After a meteoric rise in the market during the last few years, the future of e-cigarettes now rests with regulators, innovators.
By Howard Riell, Associate Editor
The U.S. Food and Drug Administration (FDA)’s deeming regulations on vapor products could shift the $3 billion that e-cigarettes/vape are estimated to generate this year in brick-and-mortar stores to online vendors and black market players.
Stakeholders have made the case that it’s important for the FDA to set a new predicate date in the final rule, and that Congress should update the predicate date for newly-deemed products. New FDA deeming regulations authorized earlier this year ban e-cigarette sales to Americans under age 18, among other stipulations.
From: The National Law Review
A class action failure-to-warn lawsuit against e-cigarette companies was thrown out by the Central District Court of California last week. The suit, filed by plaintiffs from CA, IL, and NY, included claims that the accused companies, including Lorillard Tobacco Co. and Reynolds American Inc. (which bought Lorillard in 2014), deceptively advertised the health benefits of e-cig products over traditional cigarettes.
All categories will be affected, but vapor dealt biggest blow, new study reveals
ATLANTA — The FDA’s new “deeming” rules will have an impact on all tobacco categories in terms of item range and unit volume, but vaping will take the biggest hit, according to a study released at last month’s NACS Show.
Most vaping products on the market today came out after the U.S. Food and Drug Administration’s designated “predicate” release date, which means that any product put onto the market after Feb. 15, 2007, would have to undergo an onerous application and review process to stay in stores.
From: R Street
A feature of this month’s annual meeting of the Smoke-Free Alternatives Trade Association (SFATA) was a videotaped interview with Mitch Zeller, director of the Food and Drug Administration’s Center for Tobacco Products. Following the video, I participated in a panel discussion of Zeller’s statements about e-cigarettes.
Mr. Zeller clearly implied that there was no population-level evidence that smokers had quit with e-cigarettes. He said the FDA is:
…absolutely aware of the anecdotal reports about individuals using e-cigarettes to help them quit, but we can’t make population-level policy on the basis of anecdotal reports … FDA is required to use a population health standard.
Electronic nicotine delivery systems face hazy future because of stricter a regulatory policy.
By CSD Staff
Because of the deeming rule published by the U.S Food and Drug Admiration earlier this year, more tobacco products now fall under the same scrutiny as cigarettes. Today, cigars, pipe tobacco, other tobacco products including vape items and e-cigarettes face stricter regulations, however, the popular and fledging vapor industry faces a threat of being snuffed out.
Following up on our post from last Thursday, the Food and Drug Administration (FDA) has announced that it will not meet its midnight deadline to submit proposed tobacco regulations. The FDA will also miss deadlines to publish a consumer-friendly list of dangerous chemicals found in electronic cigarettes (e-cigarettes or e-cigs) and testing / reporting requirements for tobacco ingredients and additives. Unfortunately, the FDA is not required to abide by the deadlines that it sets for itself, nor is it assessed any penalty for missing such deadlines.
Written by Barnaby Page
Article contributed by Soar Payments
U.S. businesses selling e-cigarettes and other vaping products online can expect to be hard hit by new rules governing the processing of credit card payments.
Many small businesses could face a difficult and potentially costly tangle of red tape – or even the loss of their existing credit card arrangement.
Small business owners and employees of vape shops in Central Jersey are concerned about the fate of their stores under new federal rules
SOMERVILLE – Ryan Bunting spells his name in the NATO phonetic alphabet as if he were still reporting to an officer of higher command.
That’s because he spent eight years in the Marines and was deployed to Iraq in 2008.
From: American Thinker
Ever the advocate of the government solution to any problem, the United Nations has trained its sights upon e-cigarettes in recent months. The World Health Organization (WHO)’s Framework Convention on Tobacco Control (FCTC), which is the UN tentacle dedicated to policing tobacco sales and consumption around the globe, is making inroads into the vaping market, ultimately hoping to regulate e-cigarettes just as traditional cigarettes, cigars, and the like.
Editor’s Note: Cross-posted from the Counterfeit Cigarette Enforcement Forum. For more information about the $5 Man and the unintended fueling of the contraband tobacco marketplace, see Weaponizing Poverty.
From: Vape Magzine
By Norm Bour
He’s called the $5 Man and he is not an urban legend, but is very real. Those in the tobacco industry have heard of him and are fearful since he steals money. Their money. State politicians don’t like him either since he takes money from their coffers, too.
Excessive Taxation Creates Illegal Responses
From: Science 2.0
A new Cochrane Review paper provided an independent, rigorous assessment of the best available evidence to date about electronic cigarettes for quitting smoking and found that electronic cigarettes may help smokers stop their smoking, and there are no serious side effects associated with their use for up to two years.
From: Washington Examiner
Facing potential bankruptcy, the nation’s 15,000 vaping and e-cigarette outlets are mounting a massive political campaign to win a congressional reversal of new and costly Food and Drug Administration rules that just went into effect.
The “Right to Vape” campaign plans to barnstorm through 15 battleground and politically influential states to pressure lawmakers up for re-election to promise to use the upcoming November lame-duck session to make changes to the regulations.
From: The Hill
By Christopher Russell, contributor
Earlier this year, the Food and Drug Administration (FDA) finalized a rule that extended the agency’s authority to regulate electronic cigarettes and related vapor products as tobacco products. However, these products do not actually contain tobacco.
In so doing, FDA started the clock ticking toward August 8, 2018, the date on which e-cigarettes, e-liquids and other related newly deemed tobacco products that do not have FDA approval to remain on the market can no longer be legally sold.
From: Winston-Salem Journal
By Richard Craver Winston-Salem Journal
The Food and Drug Administration’s response to a legal challenge on its electronic cigarette regulations is that all such products “present significant risks to the public health,” even when nicotine-free liquids are consumed.
Nicopure Labs LLC of Tampa, Fla., became on May 10 the first liquid nicotine manufacturer to file a federal lawsuit against the FDA for the controversial smokeless tobacco rules that went into effect Aug. 8.
The new rules will discourage smokers from switching to vaping, a much less dangerous alternative.
From: Convenience Store News
Industry still objects to 2007 grandfather date.
SILVER SPRING, Md. — The 90-day countdown has ticked down and the Food and Drug Administration’s (FDA) deeming rule and its regulations for electronic cigarettes and cigars are now effective.
The agency released the final deeming rule on May 5 and published it in the Federal Register on May 10, starting the countdown. The rule also extends the FDA’s regulatory authority to hookah tobacco and pipe tobacco, as CSNews Online previously reported.
By Richard Craver
The Food and Drug Administration is forging ahead with implementing a controversial set of new regulations on tobacco and nicotine products.
The rules, made official May 5, are set to go into effect Aug. 8 for electronic cigarettes, vaporizers, cigars, hookahs (water pipes), pipe tobacco, nicotine gels and certain dissolvables. The agency’s intent is clarifying the products’ potential for causing or reducing public harm.
The Food and Drug Administration’s legal rationale for regulating e-cigarettes as “tobacco products,” even though they do not contain tobacco, is that they deliver nicotine derived from tobacco. But e-cigarettes do not always do that. There are many varieties of nicotine-free e-liquids, sold in disposable e-cigarettes, replaceable cartridges and bottles for refilling vaporizer tanks. Do those liquids and the systems in which they are used also qualify as tobacco products?
On August 8, a final rule from the US Food and Drug Administration (FDA) goes into effect that tobacco control experts say could dramatically change the status of e-cigarettes in this country. The rule extends the agency’s regulatory authority to all tobacco products, including e-cigarettes, and requires manufacturers to report product ingredients and undergo the agency’s premarket review to receive marketing authorization.
Yet some experts have expressed misgivings about unintended consequences of tight regulations that could potentially block cigarette smoking cessation efforts by adult e-cigarette users.
From: The Hill
Legal challenges are mounting against the Food and Drug Administration’s move to regulate cigars and e-cigarettes, which for the first time would be treated just like traditional tobacco products under new rules.
As many as five lawsuits have been filed against the agency over the rules finalized in May, which require any product that hit store shelves after February 2007 to go through a costly approval process.
From: The Daily Signal
On May 5, the U.S. Food and Drug Administration finalized a rule known as the Deeming Regulation, extending its authority under the Family Smoking Prevention and Tobacco Control Act, or Tobacco Act, to all tobacco products, including electronic cigarettes (e-cigarettes), also known as vapor products.
It sounds good, but when all the facts are known, some enduring myths about the new regulations emerge from the mist. Do the new regulations actually accomplish the following?
From: Winston-Salem Journal
A study on the use of electronic cigarettes and vaporizers in the European Union determined that nonsmokers rarely use them and that 67 percent of smokers who do use them either quit or smoked fewer traditional cigarettes.
The study, with researcher Dr. Konstantinos Farsalinos of the University of Patras in Greece serving as principal investigator, involved 27,460 EU residents at least 16 years of age. It included representatives from all 28 member states.
From: Convenience Store News
WASHINGTON, D.C. — The Right to Be Smoke-Free Coalition, American E-Liquid Manufacturing Standards Association, American Vaping Association and the Electronic Vaping Coalition of America are among several trade associations and state associations to file a lawsuit June 20 against the Food and Drug Administration (FDA) regarding its recently released final deeming rule.
The deeming rule extends the FDA’s authority to all tobacco products, allowing it to now regulate electronic cigarettes, cigars, hookah tobacco, pipe tobacco and more, in addition to cigarettes and smokeless tobacco, which have fallen under its authority since Congress passed the Family Smoking Prevention and Tobacco Control Act of 2009.
Evidently, their Orwellian behavior wasn’t crazy enough, so the feds went full Terry Gilliam on us, pulling the Centers for Disease Control (CDC) into the circus. On April 14, the CDC announced this rousing headline: “No Decline In Tobacco Use Since 2011”.
This was, of course, insultingly false, which the CDC itself had already admitted, if one recognizes the distinction between tobacco products and non-tobacco products.
From: Inside Sources
by Graham Vyse
What if the Food and Drug Administration’s crackdown on e-cigarettes actually leads to more smokers?
That was one of many concerns raised during Thursday’s vaping forum at the American Enterprise Institute, one of the Washington’s top conservative think tanks.
From: The Daily Caller
Guy Bentley, Reporter
From: JDSupra Business Advisor
Days after the publication of the Food and Drug Administration’s controversial final rule regarding e-cigarettes (and other nicotine-delivering products), a company called Nicopure Labs LLC filed a lawsuit challenging it in the U.S. District Court for the District of Columbia. Nicopure seeks to have the rule vacated and declared unlawful, and has requested a preliminary injunction barring enforcement of the rule and prohibiting the FDA from taking any action under the rule pending resolution of the lawsuit.
In this episode of the weekly Budget & Tax News podcast, managing editor and research fellow Jesse Hathaway talks about the U.S. Food and Drug Administration new “deeming regulations” for electronic cigarettes, which require e-cigarette manufacturers to submit their products through an arduous federal approval process.
Cynthia Cabrera, president of the Smoke-Free Alternatives Trade Association, the largest e-cigarette and smoke-free alternative trade association representing the interests of manufacturers, online retailers, small businesses, distributors, importers and wholesalers, and someone who the people in Big Tobacco probably find really annoying, joins Hathaway to talk about the new regulations, and how they will affect consumers, both non-smoking and smoking alike.
From: Parent Herald
By Catherine Armecin, Parent Herald
FDA Regulations Force Consumers To Turn To The Black Market
Per the report, with the new FDA regulation, more than 90 percent would turn to the black market. Meanwhile, over one-fifth of vapers who already quit smoking responded that they would turn to cigarettes.
Additionally, 46 percent planned to increase the amount they smoke. This suggests that e-cigarette smokers would continue to use their choice even if they have to breach the law.
The agency’s final rule leaves conventional cigarettes on the market while requiring much safer alternatives to meet prohibitive requirements.
Today the Food and Drug Administration (FDA) announced what amounts to a slow-motion ban on e-cigarettes, ignoring the pleas of harm reduction advocates who say it makes no sense to prevent smokers from switching to nicotine products that are indisputably much less hazardous than the ones they are using now. The FDA rule, a preliminary version of which was published two years ago, effectively requires e-cigarette manufacturers to get their products approved as “new tobacco products,” an expensive, arduous, and time-consuming process that will be prohibitive for most, if not all, of them.
From: ars technica
Fierce debate erupts as sides fight to protect children and smokers from tobacco.
by Beth Mole
The 2017 Agriculture Appropriations Bill may not seem like a stirring piece of legislation to most, but it raised quite a few eyebrows last week as it passed through a House subcommittee with a key amendment—one that aims to spare the vast majority of electronic cigarettes from impending federal regulations.
From: Science Daily
Date: April 25, 2016
Source: Georgetown University Medical Center
Summary: Seven top international tobacco control experts are prompting regulators at the US Food and Drug Administration to have a broad ‘open-minded’ perspective when it comes to regulating vaporized nicotine products, especially e-cigarettes.
“We’re concerned the FDA, which has asserted its right to regulate e-cigarettes, will focus solely on the possibility that e-cigarettes and other vapor nicotine products might act as gateway to cigarette use,” says Levy, a professor in the department of oncology at the Georgetown Lombardi Comprehensive Cancer Center.
Tobacco industry expecting final rule this month
WASHINGTON — Tobacco industry and anti-tobacco groups are expecting the U.S. Food & Drug Administration (FDA) this month to release its long-awaited final rule “deeming” whether it can regulate cigars and electronic cigarettes, according to a report by The Hill.
While FDA spokesperson Michael Felberbaum told the newspaper that he did not have any update to share on the timing of the deeming rule’s release, most industry observers believe a final rule is imminent.
The long-awaited Food and Drug Administration’s rule to regulate cigar and e-cigarettes is believed to be coming later this month.
WASHINGTON – The Hill reports that the Food and Drug Administration could be ready to release its long-awaited final rule to regulate cigars and electronic cigarettes this month.
Initial findings were reported a year ago at the 2015 Society for Research on Nicotine and Tobacco (SRNT) annual meeting in Philadelphia, with findings published last fall in the Journal of the American Medical Association. Researchers found that 40 percent or more of smokers reported using both cigarettes and other tobacco products, including e-cigarettes; while the majority of young smokers said their first experience with tobacco included trying a flavored product.
The objective of the study is to provide information to support population-based tobacco regulations to reduce the disease burden caused by tobacco.
Where there’s smoke, there’s cancer, even if it isn’t inhaled.
That’s the position of the U.S. Food and Drug Administration, which is preparing to crack down on cigars because of their health risks, even as a new law makes it easier for Americans to obtain Cuban cigars.
From: Winston-Salem Journal
By Richard Craver Winston-Salem Journal
A second Ivy League study has found a connection between higher age requirements for purchasing electronic cigarettes and increased use of traditional cigarettes by youths.
Researchers with Weill Cornell Medicine, in a study published this month in Preventive Medicine, said lawmakers “should be cautious” in establishing the same legal purchasing age for electronic devices as for traditional cigarettes, which is age 18 in most states.
From: Daily Caller
Guy Bentley, Reporter
A new vape industry group is promising to fight tooth and nail against “junk science,” severe regulations and widespread misinformation about e-cigarettes.
The Washington, D.C.-based Vapor Technology Association (VTA) represents manufacturers, importers, wholesalers, distributors, suppliers and retailers and boasts 70 members since being launched Jan. 27.
By Melissa Vonder Haar, Tobacco Editor, CSP
But retailers are not necessarily embracing every new product with open arms. And for good reason. “The c-store channel has had its fair share of challenges,” Wiesehan says.
One major challenge is regulatory uncertainty. What good is an exciting and innovative new product if it’s doomed to be pulled off the shelves once FDA regulations go into effect? (The final regulations had not been announced at the time this article was written.)
by Jimmy Hafrey
In the heart of North Carolina, there is a growing company that is setting the vape industry on fire. Smoke Crossroads put down roots in Greensboro a little over two and a half years ago and since then, their passion for vaping has impacted thousands of former smokers and helped them cross over to a tobacco-free way of life. Owners Allen and David are passionate about what they do and they aren’t shy about the fact that they believe vaping is the best option for smokers who can’t otherwise kick the habit. We had the chance to get to know the team at Smoke Crossroads recently and we were so impressed with their mission that we thought our readers deserved to hear about this crazy cool operation.
From: Scientific American
The agency will be tackling thorny topics including food safety, biologic drugs and how to regulate e-cigarettes
By Reuters Staff
WASHINGTON (Reuters) – The U.S. Senate voted overwhelmingly on Wednesday to confirm Dr. Robert Califf as head of the Food and Drug Administration, an agency that regulates everything from food and drugs to tobacco, cosmetics and dietary supplements.
Califf, 64, a well-regarded cardiologist and researcher, takes the helm at the FDA when lawmakers are pressuring the agency to speed the approval process for drugs and medical devices and finalize a proposed rule giving it authority to regulate e-cigarettes.
From: Charleston Gazette-Mail
Regulations advocated by various groups, including the CDC and FDA, would make it so onerous to approve e-cigs as a “harm reduction” strategy that — even if approved — they would likely cost $10 or more per use, encouraging tobacco smokers to stick to cigarettes. Banning the use of these devices in public where they emit essentially the same substances as normal respirations — and far less than certain cooking, grilling and commercial processes — makes little sense scientifically. Theoretical risk of explosion or release of certain toxins at exceptionally high temperature are rarely reported and could be easily controlled by engineering changes and safety regulations.
From: The National Law Review
Sheila A. Millar, Azim Chowdhury, Nathan A. Cardon
For all of you who know the U.S. Consumer Product Safety Commission (CPSC), you know that the agency distinctly does not have authority over tobacco or tobacco products. This arguably wasn’t always the case. Early on, the American Public Health Association petitioned the CPSC to regulate cigarettes containing more than 21 mg of tar. When the Commission voted not to take action, a district court ordered it to under the Federal Hazardous Substances Act (FHSA), but Congress amended the law before the CPSC could take action. See Consumer Product Safety Commission Improvements Act,Pub. L. 94–284, 90 Stat. 503 (May 11, 1976); see also Food & Drug Administration v. Brown & Williamson Corp., 529 U.S. 120, 150–151 (2000) (discussing the petition, litigation, and statutory amendment). Tobacco and tobacco products have been explicitly excluded from CPSC jurisdiction since that 1976 law.
Germany is to ban menthol e-liquid as well as many other flavours when it transposes the EU’s Tobacco Products Directive (TPD).
A lengthy, although still only provisional, list of restricted ingredients includes additives that facilitate the inhalation or uptake of nicotine, such as the minty-tasting flavouring which has long been the subject of controversy in regulation of tobacco cigarettes.
From: Batavia News
By SCOTT DESMIT
Scaccia owned A Plus Vapes & Deals at 327 Ellicott St. Federal agents raided the business in April 2015 and seized about 90 counterfeit vaporizers.
U.S. Assistant Attorney Scott Allen Jr. said Scaccia told investigators that he obtained the vaporizers from his brother in California and through a Chinese website called AliExpress.com.
The White House Office of Management and Budget (OMB) is currently reviewing new federal regulations requiring all e-cigarette products sold after February 15, 2007, to apply for federal Food and Drug Administration (FDA) approval, regardless of whether they are new products or previously created.
The proposed FDA “deeming rule” would also extend the agency’s tobacco regulatory authority to consumer products without tobacco, such as e-cigarettes.
Prohibition, Not Regulation
From: GAO WatchBlog
Up to 90% of electronic cigarette devices in the multi-billion-dollar U.S. e-cigarette market are imported, according to expert estimates.
But until recently, the federal government couldn’t determine the volume of e-cigarette imports because they were lumped together for tracking purposes with things like glow sticks and hand-held calorie counters. Starting January 1, 2016, there are new tracking codes for imported e-cigarettes. What does this mean? Today’s WatchBlog explores.
From: The Province
Regulator Watch: Ontario delays vaping regulations, rest of the country braces
The hammer fell hard on vapers in 2015 as provincial governments across Canada began passing tough new laws intended to strictly regulate the use and sale of vapour products.
Glimmers of hope emerged in the final weeks of the year. The Ontario provincial government announced it would delay key aspects of its new regulatory regime and British Prime Minister David Cameron acknowledged the health benefits of vaping. Yet still, it’s hard to overstate the challenges facing vapers as the calendar turns to 2016.
E-cigarette advocates call omission a “modern-day prohibition”
By Melissa Vonder Haar, Tobacco Editor, CSP
WASHINGTON — A rider that would have helped electronic-cigarette manufacturers better survive the upcoming U.S. Food and Drug Administration (FDA) deeming regulations was not included in the final $1.1-billion spending bill legislators approved earlier this month. Approved by the House Appropriations Committee’s Agriculture, Rural Development, Food & Drug Administration & Related Agencies Subcommittee in June, the rider would have exempted products already on the market from the FDA’s cost-prohibitive Pre-Market Tobacco Application (PMTA) requirement, allowing companies to instead submit a less costly substantial equivalence (SE) application.
From: Daily Caller
A policy rider that could’ve saved 99 percent of the e-cigarette of from de facto prohibition failed to make it into the House’s omnibus spending bill released Tuesday night.
The rider would’ve changed the Food and Drug Administration‘s (FDA) rules requiring all e-cigarette products released after February 15, 2007, to undergo the costly Pre-Market Tobacco Applications (PMTA) process. This provision was vitally important to vaping businesses and advocates because the cost of the PMTA process for each individual product can run between $2-10 million.
By Thomas A. Briant, NATO Executive Director
This year has been marked by both anticipation of the FDA’s deeming tobacco regulations and other actions by the agency as it moves forward with regulating tobacco products. Most of the attention has been focused on finalizing the extension of the agency’s authority to cigars, pipe tobacco, e-cigarettes, hookah tobacco, dissolvables and nicotine gels. However, the other actions pursued by the FDA in 2015 are just as important.
From: NACS Online
More than 30 meetings are planned with White House officials as the final review of new regulations takes place.
WASHINGTON, D.C. – Ahead of some of the most sweeping changes to rules governing cigars and e-cigarettes, industry groups and health advocates have been bending the ear of the White House to press their suggestions, The Hill reports. The Office of Management and Budget (OMB) is conducting a final review of the new regulations, which move cigars and e-cigs under the U.S. Food and Drug Administration (FDA) for the first time.
Robert Califf, MD, who is currently deputy commissioner of the Food and Drug Administration (FDA), was nominated by President Barack Obama on Sept. 15, 2015, to be the FDA’s commissioner.
Among the early issues facing Califf if he’s confirmed is the regulation of e-cigarettes and the challenge of getting drugs to market sooner. At the time of his appointment as deputy commissioner, Califf said he was in favor of streamlining the drug approval process.
From cigarette vending machine bans to flavor prohibition
From: Winston-Salem Journal
Dr. Michael Siegel, a professor at the Boston University School of Public Health, expressed concern that the FDA’s goal with the pathway requirement will drive most small businesses, vape shops and e-cigarette companies out of business due to the high regulatory cost combined with a lack of resources and scientific expertise.
“It might be the case that not even the largest manufacturers – such as the tobacco companies – could be able to technically complete a successful application under the FDA deeming regulations and guidance,” Siegel said.
Cigar News: Leaked Draft of FDA Cigar Deeming Rule Raises More Questions About FDA Rulemaking Process
From: Stogie Guys
Two weeks ago, e-cigarette trade group Tobacco Vapor Electronic Cigarette Association (TVECA) said it was in possession of a copy of the the deeming rule sent from the Food and Drug Administration (FDA) to the Office of Management and Budget (OMB) for final review before publication and implementation. Initially, the group leaked a copy of the table of contents and promised to leak the full document soon after.
Although the documents were never fully authenticated, every indication points to the document being legitimate. The FDA even took the unusual step of issuing a statement acknowledging the leak and stating they had an understanding that no more of the document would be made public.
The FDA has not yet issued its final rule and other documents related to extending the agency’s authority to other currently unregulated tobacco products. We are aware that the Tobacco Vapor Electronic Cigarette Association (TVECA) has indicated publicly that it has a copy of the draft final rule. We cannot confirm if TVECA has a copy of the most recent version of the draft final rule, or even if their copy is authentic. It is our understanding based on recent conversations between the FDA and TVECA, that the group will not be releasing the document in question.
The Tobacco Vapor Electronic Cigarette Association (TVECA) claims that it has gotten its hand on the proposed final ruling of the deeming regulations from the U.S. Food & Drug Administration (FDA), and in it, there doesn’t appear to be great news for the cigar industry.
we now possess critical documents concerning the future of the industry in the US. We will headline this information tomorrow on all outlets
From: The Cigar Authority
This morning sources to The Cigar Authority informed us that the White House Office of Management and Budget has received a copy of the final FDA Deeming Regulations. The document which was rumored to be in their hands for more than a week has been officially acknowledged.
Update: According to Cigar Rights of America, the OMB process could take 60-90 days although the FDA is pushing for an expedited process.
From: Khaleej Times
Asma Ali Zain/Dubai
The UAE is laying down regulations for e-cigarettes which may ease the ban on the sale of the product in the country. In January this year, authorities from Emirates Authority for Standardisation and Metrology (Esma) sent a draft technical regulation to the World Trade Organisation (WTO) notifying them of the country’s intention to regulate the sale of e-cigarettes.
The document that was sent to the WTO and a copy of which is with Khaleej Times states that the objective of the regulation is to protect human health by ensuring that quality products are available in the market.
Alex Brill | | Public Comment Submitted to the Food and Drug Administration
This comment letter responds to the Food and Drug Administration’s advance notice of proposed rulemaking (ANPRM) regarding warnings and child-resistant packaging for liquid nicotine. My views on the ANPRM, described in greater detail in the letter, can be summarized as follows:
1. The increase in the number of calls to poison control centers related to e-cigarettes is not the best metric for determining the need for and appropriateness of exposure warnings and child-resistant packaging requirements for e-cigarettes. FDA should rely instead on comparative data that quantify the risks posed by these nicotine products relative to other household products and impose restrictions and requirements according to these relative risks.
If proposed FDA rules are finalized, as expected, most vaping shops will not survive, many say.
When Randy Freer was trying to quit smoking, he wanted to try vaping — battery-operated devices that deliver nicotine by vaporizing liquids. (Some ex-smokers find the combo of the flavors and the ability to dial down the nicotine helps them quit.) But Freer found he couldn’t keep a supply of the vaporizers he liked — they were always out of stock.
From: Vaper Soul
by Mr. Cloud
The Future of Vaping
The on-going e-cigarette regulations have thrown vaping into a confusing state and its future seems bleak. Many people predict that proposed FDA e-cigarette regulation could lead to the death of vaping all together. But is this the case? Are the unanimously-grim predictions for the future of the industry going to come to pass, or is there a way to change things? Can we save vaping?
With help from seven prominent advocates and vapers, Black Note delved into the issues that are responsible for this dark cloud hanging over the future of vaping, aiming to determine whether the predictions will really come to pass.
GAO: ELECTRONIC CIGARETTES, Effect on Federal Excise Taxes Collected on Traditional Cigarettes Is Not Currently Evident
Editor’s Note: The complete report GAO-15-771 is available here. Below is an excerpt.
From: Winston-Salem Journal
The thick fog — reaching from floor to ceiling at VapeMania 15 — was a clear sign of those consumers’ preference for vaporizers over electronic cigarettes at a time when just 15.2 percent of adult Americans smoke combustible cigarettes.
Traditional e-cigs are battery-powered devices that heat a liquid nicotine solution in a self-contained disposable cartridge and create a vapor that is inhaled. The manufacturers have provided few flavor choices, in part in expectations that the Food and Drug Administration eventually may limit flavorings as it does with combustible cigarettes.
From: The Hill
E-cigarette manufacturers and public health groups are sparing over a new study that claims the non-tobacco products are 95 percent safer than regular cigarettes.
The report commissioned by Public Health England (PHE), an independent panel of experts in the United Kingdom also found that of 2.6 million adult e-cigarettes users in that country, almost all are using a vapor device to help them quit smoking.
From: The Hill
By Lydia Wheeler
The Obama administration is delaying its plan to regulate how electronic cigarettes are packaged.
The Food and Drug Administration (FDA) announced in June that it was drafting rules for manufacturers, but that it wanted the public to weigh in first on what warning labels and childproof packaging should look like for products in the burgeoning vapor industry.
From: The Hill
Electronic cigarette manufacturers are fighting to change a provision in looming regulations for electronic cigarettes that they warn would all but wipe out 99 percent of the burgeoning industry.
In it’s proposed rule to assert, for the first time, its authority over e-cigarettes, the Food and Drug Administration said all products that hit stores after February of 2007 would have to apply retroactively for approval — a process that companies say would be prohibitively expensive.
From: York Dispatch
By SARA BLUMBERG
When Gregory Conley gives talks about tightening federal regulations related to e-cigarette and vape products, he usually gets three reactions.
1. He’s preaching to the choir.
2. People realize it’s worse then they thought.
3. Pure shock.
Conley, president of the American Vaping Association, an industry advocacy group, said the new regulations proposed by the U.S. Food and Drug Administration would eliminate 99 percent of the thousands of vape shops that have popped up around the country.
From: Medical Xpress
Virginia Commonwealth University Massey Cancer Center researchers at the VCU Center for the Study of Tobacco Products (CSTP) have developed the first ever, evidence-based model that can predict with up to 90 percent accuracy the amount of nicotine emitted by an electronic cigarette (e-cigarette). The study was published in the journal Nicotine and Tobacco Research.
From: FDA Voice (FDA.gov)
By: Cathy L. Backinger, Ph.D., M.P.H. and Cindy Miner, Ph.D.
We Need a Strong Science Base to Address Issues that Matter Now
In 2009 Congress passed the Family Smoking Prevention and Tobacco Control Act, creating the Center for Tobacco Products (CTP) at FDA and giving us the responsibility to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco to protect public health.
From: Hays Post
The promise of new regulations by the Food and Drug Administration regarding nicotine juices for electronic cigarettes – commonly known as e-cigs – has local businesses concerned about damage to their bottom line. Theresa Herlocker, owner and manager of Grasshopper Vapes, 706 Vine, believes that while some regulation is necessary, over-regulation by the federal government could hurt the market and drive smaller shops out of business.
From: The Weekly Standard
The case for leaving cigarette flavorings alone.
By ELI LEHRER
From Brussels to Chicago to the headquarters of the Food and Drug Administration in White Oak, Maryland, public health officials, antismoking crusaders, and mayors are waging a battle against flavorings for both tobacco cigarettes and newer e-cigarettes.
The confluence of these trends in public health—toward banning flavorings and treating e-cigarettes the same as their deadlier combustible cousins—could get ugly fast. It could herald a new Prohibition. It would be Prohibition in all but name for cigarettes, as the law would allow few attractive alternatives for those who crave nicotine.
From: NACS Online
Anticipated FDA rules likely to require expensive approval process for all vape products, leading to possible “vapocalypse.”
NEW YORK – The Wall Street Journal took a look this week at the possible ramifications for the burgeoning – and profitable – vapor business, when the FDA unveils new regulations for e-cigarette products.
According to the WSJ, within the next two months, the FDA is expected to complete rules that would require federal approval for nearly all flavored liquid nicotine juices and e-cigarette devices. Regulatory consultant SciLucent estimates that the product approval process under the new rules could cost anywhere from $2 million to $10 million for each item being regulated.
Editor’s Note: A tax or regulation that puts a business out of business is a ban.
From: Washington City Paper
But Robinson and other vape shop owners in D.C. say an all-but-approved tax increase on their products will force them out of business. Members of the D.C. Council, on the other hand, say the matter is a public health issue, plain and simple.
“They’re going to put us out of business,” Robinson says, “and they don’t care.”
From: News Medical
Source: University of Southern California
“We weren’t surprised that the web is being used to circumvent tobacco regulations,” said Jon-Patrick Allem, PhD, a postdoctoral fellow with the USC Tobacco Center of Regulatory Science (TCORS) and corresponding author on the study. “Most surprising was the constant rate of interest in the illegal products (the cigarettes) versus the legal products (cigars).”
The study is among the first to examine the reactions of consumers and the tobacco industry to flavored cigarette bans, which are also in force in the European Union and other countries.
From: The Hill
By Lydia Wheeler
The House Appropriations Rural Development, Food and Drug Administration and Related Agencies Subcommittee approved a $20.65 billion agriculture appropriations bill Thursday that would make it harder for the Food and Drug Administration to remove electronic cigarettes on the market now from store shelves.
If enacted, the bill would keep the FDA’s Center for Tobacco Products from forcing e-cigarettes already on the market to go through a lengthy and potentially costly Premarket Tobacco Review application process under the Federal Food, Drug and Cosmetic Act. The FDA would still be allowed to regulate how the products are made, packaged and sold.
From: FDA Voice
By: Cathy L. Backinger, Ph.D., M.P.H. and Cindy Miner, Ph.D.
How dramatic is the increase in e-cigarette use? Why are flavored little cigars and cigarillos increasingly popular among ethnic minorities? What would happen if we reduced the amount of nicotine in cigarettes so that they were no longer addictive?
These are just some of the questions that FDA-funded scientists are answering. Often research is focused on innovation and discovery to expand the body of scientific knowledge. Regulatory science is different—and exciting in its own way. How often do scientists get to see their research findings used to improve people’s lives? Tobacco regulatory scientists are doing just that.
Editor’s Note: The complete GAO report GAO-15-491R is available here. Below is an excerpt.
Results in Brief
E-cigarette import volume and tariff revenue are unknown, because the Harmonized Tariff Schedule of the United States (HTS)—which is used to classify U.S. imports and exports for tariff and other purposes—does not contain statistical reporting numbers specific to e-cigarettes. E-cigarettes, e-cigarette parts, and e-cigarette liquid are imported under HTS statistical reporting numbers for residual or basket categories that cover a range of goods, such as special effects strobe lights, seaweed extracts, and hand sanitizer. As a result, although CBP collects data on import volume and tariff revenue for the basket categories that include e-cigarettes, parts, and liquid, CBP officials said that they are unable to identify the volume of and tariff revenue from e-cigarette imports within these categories.
The critics’ anxieties are not without merit, but they need to be placed in the context of the good that e-cigarettes do by sparing nicotine-dependent individuals from carcinogenic smoke. Precautionists are unmoved by the harm that comes to smokers who have failed to quit but who cannot take advantage of less dangerous ways of using nicotine. Accordingly, this camp seeks heavy regulatory oversight by the FDA and bans on television advertising and on vaping in public.
From: New York Times
“We need a national debate on nicotine,” said Mitch Zeller.
Zeller is the director of the Center for Tobacco Products, a division of the Food and Drug Administration created in 2009 when Congress passed legislation giving the F.D.A. regulatory authority — at long last! — over cigarettes. In addition, the center will soon have regulatory authority over other tobacco products, including electronic cigarettes, which have become enormously controversial even as they have gained in use. Through something called a “deeming rule,” the center is in the process of asserting that oversight over e-cigarettes.
From: National Review
by Sally Satel
What is driving the controversy over e-cigarettes? At its core lies a tension between two camps: the precautionists and the pragmatists.
From: Motley Fool
Reducing the harm associated with tobacco use is a legitimate aim. … What is needed to determine how best to achieve this is good-quality science…
— Jeff Stier, senior fellow at the National Center for Public Policy Research.
To obtain this “good quality science,” the U.S. Food and Drug Administration next month will announce a new regulation “deeming” electronic cigarettes (e-cigarettes) and the nicotine-laced e-liquid that fuels them to be products subject to the Food, Drug, and Cosmetic Act. Products that, like tobacco, need government regulation.
Stier, who directs the National Center’s Risk Analysis Division, also will moderate a panel on strategies and goals for advancing harm reduction after the FDA announces its new regulations on e-cigarettes, which is expected sometime next month.
FDA is announcing a public workshop to gather scientific information and stimulate discussion among scientists about electronic cigarettes (e-cigarettes). The focus of this workshop will be the impact of e-cigarettes on population health, including prevalence and patterns of use, impacts of e-cigarettes on tobacco product users and non-users, and knowledge, attitudes, and beliefs about e-cigarette products. A workshop on December 10-11, 2014, focused on e-cigarette product science, product packaging, constituent labeling, and environmental impact; and a workshop on March 9-10, 2015, focused on the impact of e-cigarettes on individual health.
From: Morgan Lewis
While FDA’s tobacco products “deeming rule” is pending, the Agency issues Warning Letters to e-cigarette and e-liquid companies for the first time.
The US Food and Drug Administration (FDA or the Agency) is not waiting to finalize the “deeming rule” before taking enforcement action against electronic cigarette (e-cigarette) and e-liquid companies. As discussed in our previous LawFlash on the subject, FDA issued the proposed “deeming rule” almost a year ago, which for the first time establishes federal regulatory authority over e-cigarettes, cigars, pipe tobacco, dissolvable tobacco products, and nicotine gels (deemed tobacco products).
Should e-cigarettes be regulated? If so, how should they be regulated? Public health experts are divided on these issues. Some argue for a soft approach, lest regulations impede the potential of e-cigarettes to allow heavy smokers to cease smoking. Other experts call for stricter regulations or banning e-cigarettes altogether, claiming that e-cigarettes pose significant health risks, including the risk of hooking young people on nicotine.
On the one side, there are public health officials who want people to proceed with caution because much of the medical evidence is still uncertain. E-cigarettes, after all, have only been around for a decade, which means there are many unknowns about their long-term health consequences.
By contrast, the vaping community sees e-cigarettes as a powerful tool to get people off tobacco. Even if e-cigarettes have side effects, these advocates say, they can’t possibly be as harmful as regular cigarettes. Many believe these devices have saved their lives, and they see any effort to slow down the adoption of e-cigarettes through regulation as extremely harmful.
From: JDSupra Business Advisor
Ahead of finalizing FDA’s tobacco products “deeming” rule, the FTC considers taking enforcement action against e-cigarette firms for violative advertising, marketing, and sales practices.
It has been nearly a year since the US Food and Drug Administration (FDA or the Agency) published a proposed rule establishing, for the first time, federal regulatory authority over electronic cigarettes (e-cigarettes), cigars, pipe tobacco, dissolvable tobacco products, and nicotine gels (deemed tobacco products).
From: Agent Vape
Editor’s Note: The complete Report of the Standing Committee on Health, VAPING: TOWARD A REGULATORY FRAMEWORK FOR E-CIGARETTES, is available here. Below is an excerpt from the Introduction,
On 29 September 2014, a letter from the Minister of Health to the Chair of the House of Commons Standing Committee on Health (the Committee) stated: “Due to a lack of evidence on the benefits or harms of e-cigarettes, it would be helpful for the Standing Committee on Health to study their potential risks and benefits, seek advice from a variety of health stakeholders, and provide a report.”1
Customer Service Sentinel, Guest Blogger and Regulations Expert Tim Zeller is back to explain the FDA’s e-cigarette regulation workshops.
On Monday, March 9, the FDA will begin the second of three expected e-cigarette regulation workshops. The first e-cigarette regulation workshop took place in 2014. Before the second workshop starts on Monday, we’re going to try to clarify the sometimes difficult-to-understand aspects about the FDA’s role in the e-cig industry. What is the purpose of FDA e-cigarette workshops? Are they going to regulate the e-cigarette industry? What e-cigarette regulations are being considered?
From: The Daily Targum
By Dan Corey
While the United States Food and Drug Administration (FDA) is considering expanding its regulatory reach beyond traditional cigarettes to e-cigarettes, University professors are now investigating trends in how the public reacts to electronic cigarette policies.
With a nationally representative sample of 519 smokers during a two-week period last April, a study conducted by two Rutgers professors aligned with previous studies, showing that the public thinks e-cigarettes are generally less harmful than traditional ones.
From: Health Affairs (Blog)
by Wendy Parmet
[Health Affairs] Editor’s note: This post is part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come. A full agenda and links to video recordings of the panels are here.
From: FedBizOps,gov | GSA
This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This solicitation is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures, as applicable.
The solicitation number is FDA-SOL-1144027. This solicitation is issued as a Request for Quote (RFQ).
Early last week, the nation’s new Surgeon General, Dr. Vivek Murthy, said health officials are “in desperate need of clarity” on electronic cigarettes to help guide policies. The technology should be embraced, he said, if evidence shows e-cigarettes are able to help those who otherwise have trouble quitting smoking.
Dr. Murthy is right to ask for more evidence – though the fact that e-cigarette vapor contains no deadly tar is reason enough to encourage smokers to switch if other methods have failed them. But the most urgent need is for an honest discussion; this is nearly impossible as the drum beat of disinformation seems to be getting louder.
From: AP via StarTribune
Article by: MICHAEL FELBERBAUM, Associated Press
RICHMOND, Va. — Public health officials are “in desperate need of clarity” on electronic cigarettes to help guide policies, the nation’s newly appointed surgeon general said Tuesday.
Dr. Vivek Murthy, whose predecessors have been instrumental in guiding tobacco control, addressed the battery-powered devices that heat liquid nicotine during a stop in Richmond as part of a cross-country listening tour. The U.S. Senate confirmed the 37-year-old physician and Harvard Medical School instructor’s nomination as the country’s senior public health official in December.
From: New York Times | Op-Ed
By SALLY SATEL
WASHINGTON — ELECTRONIC cigarettes, battery-powered devices that convert a solution of nicotine and other chemicals into a vapor that can be inhaled, or “vaped,” have the potential to wean a vast number of smokers off cigarettes. No burned tobacco leaves, no cancer-causing tar: a public health revolution in waiting.
The problem is, not enough smokers are switching to e-cigarettes, despite their relative safety — and understandably so. Smokers are barraged with news about inaccurate labeling, shoddy counterfeits and poorly made e-cigarettes that emit toxins and cancer-causing chemicals in vapor. And to the frustration of smokers, public health experts and, yes, manufacturers, the Food and Drug Administration, which has not yet set up sensible regulations, is making the situation worse.
From: The Salt Lake Tribune
The electronic cigarettes that are currently all the rage may contain much more nicotine than their labels show. Or much less.
That’s the finding of a new study by the Salt Lake County Health Department and the Center for Human Toxicology at the University of Utah, a health department news release said.
Researchers found that 61 percent of the e-cigarettes they bought at 14 vape shops and 16 tobacco specialty stores had nicotine levels at least 10 percent higher or lower than the label showed.
They haven’t been studied enough yet for effects to be understood.
Electronic cigarettes have passed the $1 billion-a-year mark, so naturally they are catching the attention of public officials. Indiana Attorney General Greg Zoeller is calling for the FDA to regulate the product, and there are indications the General Assembly will consider regulations and restrictions.
Such scrutiny is appropriate, but caution is in order, too. E-cigarette use is steadily increasing, and the health effects of the product haven’t been studied enough for new legislation to be on the solid factual footing it should be. It would be reactionary and misguided to just regulate “vaping” the way smoking is, because they are clearly not the same thing.
by Orion Jones
A new analysis of thirteen scientific trials suggests that electronic cigarettes can help smokers reduce their amount of nicotine intake and even quit smoking all together.
E-cigarettes have only been in production since 2006, making the available scientific evidence about their effects still quite sparse, yet they appear less harmful than traditional cigarettes. And if they can help people who want to quit smoking, all the better.
When smoking traditional cigarettes made of cut tobacco leaves, paper, and a host of additives, a toxic chemical melange is created when these ingredients are burned and inhaled. But e-cigarettes work by mixing nicotine with glycerine and propylene glycol, two relatively benign chemicals, then heating the chemicals into a vapor that is inhaled.
As more teenagers vape, fewer smoke.
Survey results released last week indicate that use of electronic cigarettes by American teenagers continues to rise, even as their use of conventional cigarettes continues to fall. You might think these diverging trends would give pause to critics who worry that e-cigarettes are “reglamorizing” the old-fashioned, combustible kind. Yet opponents of vaping seem undeterred by reality’s failure to match their predictions. Longtime anti-smoking activist Stanton Glantz recently told USA Today “there’s no question that e-igarettes are a gateway to smoking.”
E-cigarettes appear to be less addictive than cigarettes in former smokers and this could help improve understanding of how various nicotine delivery devices lead to dependence, according to researchers. Although many regular users of e-cigarettes are trying to quit smoking, the Food and Drug Administration has not approved them for this use, and they cannot be marketed as a smoking cessation product.
The popularity of E-cigarettes, which typically deliver nicotine, propylene glycol, glycerin and flavorings through inhaled vapor, has increased in the past five years. There are currently more than 400 brands of “E-cigs” available. E-cigs contain far fewer cancer-causing and other toxic substances than cigarettes, however their long-term effects on health and nicotine dependence are unknown.
From: The Australian
Sean Parnell, Health Editor Brisbane
THE Abbott government has taken a tentative first step towards the regulation of e-cigarettes.
The Intergovernmental Committee on Drugs, which advises the nation’s health ministers, is hiring consultants to develop a discussion paper on the risks associated with the marketing and use of the electronic nicotine delivery systems.
The sale of e-cigarettes containing nicotine is prohibited under state and territory poisons laws and despite claims that the devices might help reduce the smoking rate, they have never been properly examined by the Therapeutic Goods Administration, which regulates other nicotine replacement therapies.
From: FDA/Federal Register
SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco Products, is establishing a public docket in conjunction with the first public workshop to gather scientific information about electronic cigarettes (e-cigarettes) as announced in Docket No. FDA-2014-N-0001-0079. Regardless of attendance at the public workshop, interested parties are invited to submit comments, supported by research and data, regarding electronic cigarettes and the public health.
DATES: Submit written or electronic comments by April 15, 2015.
From: The Guardian
Proportion of those in Great Britain who have never smoked before using e-cigarettes is negligible, according to ONS
A recent Columbia University study said it was a possibility e-cigarettes could act as a gateway to the non-electronic version and even to drugs such as cocaine. Action on Smoking and Health (ASH) estimate that there are 2.1m people in Great Britain currently using e-cigarettes.
The report states that the long-term health effects have not yet been established but doctors have said switching from tobacco to e-cigarettes could save 50,000 lives.
From: The Voice of Kaleo
Alden Alayvilla, Web Editor
With the Great American Smokeout just around the corner this Thursday, cigarette smokers may look for ways to quit. According to a KITV4 report, a study from University of Hawai‘i researchers may have the solution: e-cigarettes.
University of Hawai‘i Cancer Center Prevention and Control Program researchers Pallav Pokhrel and Thaddeus Herzog have found that smokers who use e-cigarettes as a way to quit smoking tend to be younger and more motivated to quit.
By Kate Kelland
LONDON (Reuters) – British scientists say they have found the best way yet to analyze the effects of smoking on the brain — by taking functional magnetic resonance imaging (fMRI) scans of people while they puff on e-cigarettes.
In a small pilot study, the researchers used electronic cigarettes, or e-cigarettes, to mimic the behavioral aspects of smoking tobacco cigarettes, and say future studies could help scientists understand why smoking is so addictive.
E-cigarettes use battery-powered cartridges to produce a nicotine-laced vapor to inhale — hence the new term “vaping”.
From: Northwest Herald
By JEFF ENGELHARDT
Crystal Lake officials are seeking the public’s feedback on potential e-cigarette policies.
Residents and business owners are invited to a public forum Friday from 10 a.m. to 11 a.m. at City Hall on 100 W. Woodstock St. to gather information on e-cigarettes and take a survey to indicate where they believe use of the devices should be allowed. For those who cannot make it, the educational materials and survey are available at the Crystal Lake website.
From: The Baltmore Sun
In her commentary supporting heavy-handed restrictions on e-cigarette use, Interim City Health Commissioner Jacquelyn Duval-Harvey misses a central point about how and why e-cigarettes are so widely touted as a way to reduce the harm from smoking (“Regulate Baltimore’s e-cigarettes,” Oct. 22).
By banning their use in public and indoor spaces, Baltimore would take away a competitive advantage that public health advocates should want e-cigarettes to have over regular cigarettes.
Ms. Duval-Harvey’s approach would cause the real public health heroes, former smokers who vape, to go outside bars and restaurants with other smokers. She may as well just offer them a light because many are bound to go back to smoking.
From: RIA Novisti (Russia)
MOSCOW, October 18 (RIA Novosti) – The working group of World Health Organization Framework Convention on Tobacco Control (WHO FCTC) has agreed on a draft decision on e-cigarettes regulation, final decision to be made later on Saturday.
According to the document, released on Friday, the Conference of the Parties invites parties “to consider prohibiting or regulating ENDS [Electronic nicotine delivery systems or electronic cigarettes], including as tobacco products, medicinal products, consumer products, or other categories, as appropriate.”
Tobacco Regulations and Problems Left Unresolved
Smoking used to be a big part of mainstream culture. Tobacco advertisements were prominent in just about all the major media outlets, and there were almost no restrictions on cigarette smoking in public areas, but the turning point came in 1964 when the government recognized the fact that smoking leads to increased mortality rates.
Still, it took a while for tobacco smoking to cracked down upon more seriously across the nation. Today, there are federal laws and local regulations in place that strongly discourage smoking. While these actions have caused many to quit, such measures haven’t been enough to put an end to the problem for good.
From: The Hill
By Tim Devaney
Fifty years after the U.S. Surgeon General’s first report about the dangers of smoking, public health officials are wrestling with how to regulate electronic cigarettes, as no government studies address the dangers of these products.
Senate Democrats and public health groups warn e-cigarettes will attract new smokers, including children, who have never used traditional cigarettes before. But others say e-cigarettes can help ween existing smokers off of traditional cigarettes, which are believed to be more harmful.
To this end, the FDA is currently funding 37 studies, but none of them have been completed yet.
Will cover design, liquids, aerosol, packaging, labeling, more
By Thomas A. Briant, Executive Director
MINNEAPOLIS — The Food and Drug Administration (FDA) has announced a series of three public workshops to gather scientific information and provide a forum for discussion of e-cigarettes and the public health.
These workshops will include presentations and panel discussions about the current state of scientific studies on e-cigarettes. The first workshop will be held Dec. 10-11, 2014, in Washington, D.C., and the agenda will include e-cigarette scientific studies, packaging, labeling of components and ingredients and environmental impacts. The second and third workshops will cover the topics of the health effects of electronic cigarettes on individuals and on the population as a whole.
CTP director to discuss deeming, future regulations
MINNEAPOLIS — Retailers that sell tobacco products should mark their calendars now and plan to attend the 2015 NATO Show to be held on April 22-23, 2015 at the Paris Hotel in Las Vegas, Nevada. The 2015 NATO Show will offer retailers the opportunity to hear firsthand from Mitch Zeller, the Director of the Food and Drug Administration’s (FDA) Center for Tobacco Products.
The Food and Drug Administration (FDA), Center for Tobacco Products, is announcing a public workshop to obtain information on electronic cigarettes and the public health. The workshop will include presentations and panel discussions about the current state of the science, and will focus on product science, packaging, constituent labeling, and environmental impacts. FDA intends to follow this workshop with two additional electronic cigarette workshops, with one on individual health effects and one on population health effects.
By Nick Triggle Health correspondent, BBC News
Warnings over e-cigarettes are alarmist – and increasing their use could save many lives, researchers have said.
For every million smokers who switch to e-cigarettes, more than 6,000 lives a year could be saved, according to the University College London team.
Meanwhile another group of London-based experts has attacked criticism of e-cigarettes as “misleading”.
Last week the World Health Organization called for e-cigarette use to be banned in public places and workplaces.
The WHO said this was because they could increase the levels of some toxins and nicotine in the air.
From: US News & World Report
By Randy Dotinga, HealthDay Reporter
Secondhand vapor created by one brand of electronic cigarette harbors fewer hazardous chemicals than regular cigarette smoke, although the researchers report the finding doesn’t leave e-cigarettes in the clear.
The study has caveats. For one, it doesn’t examine which hazardous chemicals in e-cig vapor actually make it into the lungs of people nearby. And the scientists only looked at indoor smoking, which is often banned in the United States.
From: Retail Gazette
E-cigarette brand Totally Wicked has announced today it is to launch a legal challenge against the EU’s Tobacco Products Directive. Alongside the UK’s MHRA, the Directive has announced its plan to regulate e-cigarettes in the UK as a ‘medicine by function’ from 2016. Electronic cigarettes are currently regulated only by general product safety regulations.
After 100 scientists and experts petitioned the WHO for greater regulation of the industry, a recent report by the Journal of Addiction has argued that regulation would “damaged health on a big scale”, according to the paper’s author Peter Hajek. This news will only fuel the “ferocious” debate taking place over the future of the electronic cigarette market.
From: National Review
My AEI colleagues Sally Satel and Alan D. Viard have a sobering op-ed discussing the FDA’s proposed regulation of the e-cigarette industry.
On balance, e-cigarettes are so much safer [than traditional cigarettes] that doctors should advise smokers who are unwilling to stop using nicotine to take up “vaping,” as e-cigarette use is called. Smokers who have tried and failed to quite using nicotine gum, patches, medications such as varenicline, or behavioral techniques should also be encouraged to switch to e-cigarettes.
UNC physicians have published a survey stating that more research must be done about the practice that physicians have taken of recommending electronic cigarettes, or e-cigarettes, as a means of quitting smoking for patients.
The Associate Director for Tobacco Prevention and Evaluation Program at UNC and leading author on the study, Dr. Leah Ranney, gave a brief summary about the study.
“We did a study of North Carolina providers, and we asked physicians about their attitudes towards e-cigarettes,” she says.
From: Real Clear Science
Posted by Alex B. Berezow
Some things in life are so indisputably true that it is a surprise that anyone disagrees. The safety and efficacy of vaccines, the benefits of GMOs, and the inability of Nicolas Cage to convincingly perform a single role all would be at the top of Captain Obvious’s list. Now, the list has a new entry: Electronic cigarettes produce far more good than harm.
Steven Reinberg, HealthDay Reporter
(HealthDay News) — Strict regulation of electronic cigarettes isn’t warranted based on current evidence, a team of researchers says.
On the contrary, allowing e-cigarettes to compete with regular cigarettes might cut tobacco-related deaths and illness, the researchers concluded after reviewing 81 prior studies on the use and safety of the nicotine-emitting devices.
“Current evidence suggests that there is a potential for smokers to reduce their health risks if electronic cigarettes are used in place of tobacco cigarettes and are considered a step toward ending all tobacco and nicotine use,” said study researcher Thomas Eissenberg, co-director of the Center for the Study of Tobacco Products at Virginia Commonwealth University in Richmond.
Only a handful of anti-tobacco measures have passed this year
By Thomas A. Briant, Executive Director
Bills to assess a new tax on e-cigarettes were proposed but not enacted in Hawaii, Indiana, Kentucky, New Jersey, Oklahoma, Oregon, Rhode Island, South Carolina, Vermont and Washington.
North Carolina enacted a tax on nicotine in a solution used for electronic-vapor products at a rate of 5 cents per fluid milliliter of consumable nicotine solution product.
From: AP via ABC News
By MICHAEL FELBERBAUM AP Tobacco Writer
The Food and Drug Administration can’t use an advisory panel’s 2011 report on menthol cigarettes because its members had conflicts of interest, a federal judge ruled Monday.
While the agency has since conducted an independent review on the public health impact of menthol cigarettes, the ruling could hinder the FDA’s ability to defend any future regulation of the minty smokes.
U.S. District Court Judge Richard Leon in Washington ordered the FDA on Monday to reconstitute the tobacco panel and barred the agency from using its older report on menthol cigarettes.
Cross-Posted from OIRA Watch
Briant offers an insider’s view of taxes, regulations and restrictions
By Mitch Morrison, Vice President & Group Editor
It could be 2016 before the FDA takes official control over cigars, pipe tobacco and e-cigarettes. In the meantime, myriad proposals, from President Obama’s near-doubling of the Federal Excise Tax to local and state initiatives to increase tobacco taxes and restrict the sale of e-cigs, should keep the country’s 175,000 sellers of tobacco products on alert.
“Even if they issued these proposed regulations tomorrow, it could be at least two years before they would go into effect.”
From: Yotta Fire
Research financed by the US Food and Drug Administration is going to give a more detailed insight into the use of cigarettes and help determine the associated risks, with a view to preventing addiction among Americans.
One team of researchers is counting the puffs taken by volunteer “vapers,” while another is occupied with scanning Facebook for posts on how people attempt to make e-cigarettes deliver extra nicotine. A third team is building a virtual convenience store for 13-17-year-olds, in order to measure how displays and price promotions influence the monors’ shopping choices.
From: OIRA Watch
Publisher’s Note: The publisher of this website was instrumental in the initiation of centralized regulatory review in the White Office of Management and Budget– its origins having begun in the Johnson Administration and utilized by eight subsequent Presidential Administrations.
A plethora of press articles are coming on line in the last eight hours which cast the OMB review in a non-favorable light. I remind all our readers that the office in OMB, the Office of Information and Regulatory Affairs, consisting of less than four dozen employees out of a million plus federal employees is the only group between an unchecked regulatory bureaucracy and the taxpayers check book.
MICHAEL FELBERBAUM, AP Tobacco Writer
RICHMOND, Va. (AP) — The public will have more time to weigh in on a federal proposal to regulate electronic cigarettes and other tobacco products.
The Food and Drug Administration said Friday that the public comment period slated to end July 9 is being extended an additional 30 days to Aug. 8 after getting lots of input on how to regulate e-cigarettes. Those are battery-powered devices that heat a liquid nicotine solution, creating vapor that users inhale. The FDA also proposed extending its authority to regulate cigars, hookahs, nicotine gels and pipe tobacco.
Regulators need to focus on nicotine delivery, acknowledge risk continuum: Zeller
By Melissa Vonder Haar, Tobacco Editor
WASHINGTON — A comprehensive nicotine policy is one of Mitch Zeller’s top priorities, the director of the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) said during a Legacy Foundation Warner Series webinar. It was something that was brought up in the preamble to the CTP’s recently released proposed deeming regulations of electronic cigarettes and vaping products.
Cost-benefit analysis viewed as radical by some.
NEW YORK – As U.S. health regulators consider what rules to impose on electronic cigarettes, in their tally of costs and benefits they have placed a value on the lost pleasure consumers may suffer if they used the products less or not at all.
According to a report from Reuters, the U.S. Food and Drug Administration says in a little-noticed document released alongside its April proposal for e-cigarette regulation that the projected benefits of the new rules — which also apply to cigars, hookahs and other vapor products — should be cut by 70% to account for the deprivation consumers would suffer.
Editor’s Note: CASAA’s comments highlight a crucial aspect of the FDA’s deeming proprosal, the regulation’s inordinate burden on small American companies.
From: Tobacco Today
Yanzhong Huang, Contributor
Amidst the growing global regulation on tobacco use and rising public awareness about the hazards of smoking, e-cigarettes are becoming a new, emerging industry. Invented by a Chinese medical researcher about one decade ago, electronic cigarettes are battery powered devices that allow users simulate smoking by vaporizing liquid nicotine (among other additives), but in fact have no tobacco. Since being first released on the consumer market in 2005, the global e-cigarette market has been growing rapidly. In the United States, e-cigarette sales have grown at an annual rate of 115 percent in the 2009-12 period. It is estimated that global e-cigarette market could increase to $10 billion by 2017. Some analysts even predict that e-cigarette use will eclipse that of combustible cigarettes in ten years. Over 95 percent of the e-cigarettes worldwide are produced in one place: Shenzhen, China.
From: Business Insider
Sarah Boseley, The Guardian
E-cigarettes are more effective than nicotine patches and gum in helping people to quit smoking, according to a study that challenges the negative views of some public health experts.
The issue of e-cigarettes has become a public health battleground, alarming those who think that their marketing and use in public places where smoking is banned risks re-normalizing tobacco.
Supporters say the vast majority of smokers are using e-cigarettes to kick their tobacco habit and that the health consequences of nicotine use without the tar from cigarettes appear, as yet, to be far less of a problem.
From: The New York Times
To the Editor:
The emerging technology of electronic cigarettes poses important questions for public health officials. Much remains to be learned about the risks of e-cigarettes to health, as well as their possible benefits, particularly for those smokers who have not been able to quit using deadly conventional cigarettes. All of us in public health are concerned about any use of e-cigarettes by children and adolescents.
It makes no sense to tax e-cigarettes like their cancer-causing alternative.
Last week, the Food and Drug Administration issued a proposal to regulate electronic cigarettes as a tobacco product. While public health and industry experts debate this much-anticipated regulation, a handful of Senate Democrats are quietly promoting the pernicious idea of extending tobacco taxes to e-cigarettes. Taxing e-cigarettes would threaten public health by penalizing a product that holds the promise of luring people away from the traditional cigarettes that have caused so much death and disease.
The first time the Food and Drug Administration (FDA) moved to regulate electronic cigarettes, it tried to ban them. Last week it took a different approach that may ultimately have a similar effect. Much will depend on whether the FDA irrationally decides to treat e-cigarettes as a menace to public health or recognizes them as a lifesaving alternative to conventional cigarettes.
From: National Public Radio
by Rob Stein
The Food and Drug Administration says it will formally propose regulating e-cigarettes.
Early Thursday, the agency unveiled a long-awaited rule that would give it power to oversee the increasingly popular devices, much in the way that it regulates traditional cigarettes.
“It’s a huge change,” FDA Commissioner told reporters in a briefing Wednesday, before the official announcement of the agency’s plans. “We will have the authority as a science-based regulatory agency to take critical actions to promote and protect the health of the public.”
The Food and Drug Administration for months has vowed to crack down on the sales and marketing practices of e-cigarette companies. Now the regulatory agency says it plans to propose rules for makers of the products as early as this month.
The policies will have big implications for a fast-growing, largely unregulated industry and its legions of customers.
If the regulations are too strict, they could kill an industry that offers the hope a safer alternative to cigarettes that could potentially help smokers quit. But the agency also has to be sure e-cigarettes really are safer and aren’t hooking children on an addictive drug.
TATEN ISLAND, N.Y. — An informal SILive.com poll revealed that Staten Islanders are overwhelmingly against FDA regulations on e-cigarettes.
Of 377 voters, 292, or 77.45 percent, believe e-cigs are a healthier alternative than conventional cigarettes and in a different class of nicotine products. Eighty-five voters, or 22.55 percent, were in favor of FDA regulations because they believe electronic cigarettes can lead to nicotine addiction.
For a borough that already has the highest number of smokers in New York City — an estimated 58,000, which amounts to 16.5 percent of the borough’s adult population — Staten Island is now home to armies of e-cig users.
From: Ottawa Sun
By Aedan Helmer
The latest round of threatening letters has been mailed out by Health Canada but electronic cigarette vendors aren’t budging.
With the border essentially closed to importing nicotine “e-juice” — Canadian Border Services seized nearly 17,000 Kg of tobacco substitutes, including those destined for e-cigarettes, last year alone — homegrown business is booming.
And despite the threat from federal agencies — with little in the way of enforcement thus far — e-cigarette retailers continue to pop up across the country, either online or in brick-and-mortar storefronts.
Article by: THOMAS BRIANT
Allow me to explain, as I have to legislators, what’s in these products and why it’s not dangerous.
The Star Tribune editorial “Take safe course on little-studied e-cigs” (March 30) unfairly criticizes Gov. Mark Dayton’s position on legislation that would regulate electronic cigarettes.
The Star Tribune Editorial Board clearly lacks an in-depth understanding of electronic cigarettes and, like many anti-tobacco advocates, would prefer to regulate these new non-tobacco products like regular cigarettes. This kind of thinking would result in a public health disservice to those smokers who are seeking to transition to using electronic cigarettes.
The attached letter from FDA’s Chief Operating Officer responds to Congressional concerns about agency regulatory actions that could increase the vulnerability of generic pharmaceutical manufacturers to lawsuits. The FDA letter suggests that the agency routinely violates the Public Participation section of President Obama’s Executive Order on regulatory review, 13563. FDA states:
FDA generally declined requests for meetings related to this issue pending publication of the proposed rule. Other than through review of the petition described above and of the comments on the petition and of correspondence from members of Congress and the public, FDA did not consult with outside parties. While FDA generally does not participate in a dialogue during the development of proposed rules, there are occasions when FDA staff will participate in a listen only session with interested parties.
Editor’s Note: The complete study, “Achieving appropriate regulations for electronic cigarettes” by Daniela Saitta, Giancarlo Antonio Ferro, and Riccardo Polosa of the University of Catania, Catania, Italy, is attached here. The article’s conclusion quotes the former director of the UK’s Action on Smoking and Health stating, with respect to e-cigarettes, that “‘there is place for regulation, but it should be to create an ‘enabling framework’ for these new, much less risky, alternatives to smoking to enter the market in a way that gives consumers confidence in switching from smoking’ [Bates, 2012].” The study abstract is reprinted below.
By KARA YORIO
As New Jersey mulls an e-cigarette tax and the medical community continues to stress the unknown health implications of so-called electronic vaping devices like e-cigarettes, a passionate community is growing in North Jersey – it’s a group of advocates largely made up of former smokers who say they quit traditional tobacco cigarettes when they started vaping.
“This completely changed my life,” said 28-year-old Adam Jankowski of Garfield, who credits vaping for quitting his six-year cigarette habit in a week last spring.
Critics of vaping are demanding regulatory action that would go far beyond current efforts to ban e-cig sales to minors under 18
By Michael McCord
One of the more eye-opening national television commercials of late shows a man using an e-cigarette in public and proclaiming his right to exercise his “free will.”
It’s stunning because by law there has been no cigarette advertising on television for more than four decades. But electronic cigarettes reside in a proverbial Wild West of no regulation and no special taxation because they aren’t cigarettes. They are nicotine delivery devices and they exude water vapor instead of tobacco smoke.
Bill would be enforced independent of FDA regulations
WASHINGTON — Despite admitting that the health implications of electronic cigarettes “are not yet clear,” five Democrats introduced a bill on Wednesday that could limit or outright ban the segments’ ability to market the new products.
U.S. Senators Barbara Boxer (D.-Calif.), Dick Durbin (D.-Ill.), Tom Harkin (D.-Iowa), Richard Blumenthal (D.-Conn.), and Edward Markey (D.-Mass.) proposed the Protecting Children from Electronic Cigarette Advertising Act, which would permit the Federal Trade Commission (FTC) to determine what constitutes marketing e-cigarettes to children, and would allow the FTC to work with states’ attorneys general to enforce the ban.
From: Los Angeles Daily News
By Richard Carmona
On the 50th anniversary of the first Surgeon General’s Report linking smoking and cancer, tobacco-caused death and disability persists, killing more than 430,000 Americans per year and disabling millions more with chronic diseases at immense social and financial costs.
The Los Angeles City Council is considering adding electronic cigarettes to the city’s current indoor smoking ban. Including electronic cigarettes in L.A.’s indoor smoking ban is a huge mistake because it may significantly hinder what is emerging as the most promising weapon yet in the fight against tobacco-related illness and death.
From: National Public Radio
by Jenny Lei Bolario
Electronic cigarettes are often billed as a safe way for smokers to try to kick their habit. But it’s not just smokers who are getting their fix this way. According to published by the Centers for Disease Control and Prevention, 1 in 5 middle school students who’ve tried one say they’ve never smoked a “real” cigarette. And between 2011 and 2012, e-cigarettes doubled in popularity among middle and high school students.
At a middle school in the San Francisco Bay Area, Viviana Turincio, an 8th grader, recently noticed some kids smoking in class — or at least, that’s what it looked like.
Editor’s Note: The following is a brief excerpt from a Medscape interview with Mitch Zeller, JD, Director of the FDA’s Center for Tobacco Products. The complete interview is available here.
Laurie Scudder, DNP, NP, Mitch Zeller, JD
Medscape: The AAP released a press statement praising the FDA for this effort but also urging increased federal regulation of all tobacco products, including electronic nicotine delivery devices (e-cigarettes). Can you discuss the current regulatory parameters under which the FDA operates? With the example of CVS, does the FDA have the authority to regulate tobacco at the point of sale?
Editor’s Note: complete article “Achieving appropriate regulations for electronic cigarettes” by Daniela Saitta, Giancarlo Antonio Ferro and Riccardo Polosa published in Therapeutic Advances in Chronic Disease is available here.
By Al Jones
KALAMAZOO, MI — The popularity of electronic cigarettes for many people is linked to using them as an alternative to tobacco smoking.
E-cigarette flavoring can be loaded with anywhere from 0 to 24 milligrams of nicotine to provide the nicotine jolt that smokers say they get with traditional tobacco products.
From: The Legal Examiner
Posted by Greg Webb
The FDA may be proposing regulations on electronic cigarettes in the very near future. “The FDA intends to propose a regulation that would extend the agency’s ‘tobacco-product‘ authorities — which currently only apply to cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco — to other categories of tobacco products that meet the statutory definition of ‘tobacco product,’” said Jenny Haliski, the FDA’s press officer for tobacco-related inquiries.
From: The Boston Globe
Lawmakers seen as cool to levy on electronic cigarettes
Aides to Governor Deval Patrick have dropped an initiative for a tax on e-cigarettes after gauging the political appetite among lawmakers and finding it limited, legislative officials said.
Administration officials checked in recent weeks to find out whether members of the Legislature. who have shied from some of the tax hikes that Patrick has previously proposed, would go along with a levy on the devices, which offer an experience similar to smoking tobacco. The administration was considering including the tax in the budget Patrick will submit next week.
by Jeff Stier
He saved his worst ban for last. Former New York City Mayor Mike Bloomberg’s nanny-state policies have left a trail of damage. His defeated soda ban, the ban on food donations to homeless shelters and other antics have cost New Yorkers money, jobs, food choices, and even their freedom to give charity.
But a bill passed by the City Council in December, and signed by Bloomberg as one of his last official acts, could cost New Yorker’s their lives. The city’s wide-ranging anti-smoking law now forbids the use of relatively harmless vapor from e-cigarettes wherever cigarette smoking is banned, not only in bars and restaurants, but in parks and on beaches. For New Yorkers trying to keep their New Year’s resolution to quit smoking, the ban is a bust.
From: The Guardian
Demand for electronic cigarettes is booming, but experts are not convinced they help people to quit smoking. Whatever the case, I am still a fan
It all started quite early on. My first words, uttered with a not-so-cherubic look on my face and a strange baby puffing sound, were: “Light! Light!” It was as if I had come out of the birth canal sucking not on my thumb, but a mini-Marlboro. Much excitement and hand-flapping ensued whenever my grandfather fired up his pipe after Sunday lunch. Family legend has it that my parents wafted my dummy through clouds of smoke just to shut me up, such was my morbid nappy-stage fascination. Age was no barrier: everyone loved smoking in the 70s.
By Rick Romell MCCLATCHY NEWSPAPERS
The surging popularity of electronic cigarettes is spurring growth at two Milwaukee-area companies that have emerged as important producers of the key ingredient, and is creating opportunity here and elsewhere for storefront entrepreneurs.
The local participants have jumped into a market that some believe will eclipse that of traditional smokes within a decade.
“This is one of those few times where you see a brand new industry, and it’s amazing,” said Christian Berkey, founder and majority owner of Hartland’s Johnson Creek Enterprises LLC, which describes itself as the country’s largest manufacturer of the flavored, nicotine-laced liquids that are at the heart of electronic cigarettes.
Where they are in the process and what’s to come
WASHINGTON — The FDA is currently on Step Four of a nine-step process to propose and adopt new rules and regulations on other tobacco products, which may include cigars, pipe tobacco, electronic cigarettes and/or hookah tobacco. Specifically, Step Four is a review of the proposed FDA tobacco rule and regulations by the White House Office of Management and Budget (OMB). Generally, under Step Four, the OMB only reviews those proposed rules or regulations that are determined to be significant.
“If e-cigarettes can reduce, even slightly, the blight of six million tobacco-related deaths a year, trying to force them out of sight is counterproductive.”
Editor’s Note: The following New York Times Op-Ed written by professors of sociomedical sciences at the Mailman School of Public Health provides regulators with a science-based approach to health policy decisions.
From: New York Times
DEBATE over e-cigarettes — battery-powered cigarette look-alikes that heat liquid nicotine but emit a harmless vapor — is raging. New York City and Chicago are considering adding e-cigarettes to their bans on smoking in bars, restaurants and parks, and Los Angeles is moving to restrict e-cigarette sales, even though e-cigarettes don’t generate smoke and, while not proved to be entirely safe for users, are undoubtedly less hazardous than tobacco cigarettes.
Editor’s Note: It’s not clear that the study has appropriately modeled causality. Or that the results can be replicated.
E-cigarettes may lead to nicotine addiction
Stephanie M. Lee, Erin Allday
E-cigarettes are promoted as safe alternates to cigarettes, but may only serve as a new route to nicotine addiction among adolescents, a new UCSF study has found.
E-cigarettes are battery-powered devices that look like cigarettes and deliver nicotine and other chemicals. Researchers assessed their use among youth in South Korea, where the devices are marketed similarly to how they are marketed in the United States.
From: Huffington Post
Chicago may soon take a first step toward becoming the first major U.S. city to regulate the sale of e-cigarettes.
The Chicago Sun-Times reports Mayor Rahm Emanuel is joining forces with two powerful alderman — Will Burns (4th) and Ed Burke (14th) — to push for e-cigarettes in Chicago to be regulated as “tobacco products” and subject to the same restrictions as are outlined in the city’s existing smoking ban.
Specifically, that means they would be banned for minors and would also not be allowed to be smoked wherever traditional cigarettes are already banned.
Editor’s Note: The following article is an argument for the balanced regulation of e-cigarettes in lieu of draconian regulatory measures which will result in an underground market for the products.
From: The Washington Post
By Donna St. George
When a teacher noticed what looked like smoke rising in her Eastern Middle School classroom one day this fall, she quickly investigated, finding an eighth-grade boy holding an e-cigarette.
The “smoke” was vapor, but for Casey B. Crouse, principal at the Silver Spring school, the episode was the first signal of what she would learn is a troubling teen trend nationally: An increasing number of students using electronic devices that simulate tobacco smoking.
I am honored to join Drs. Riccardo Polosa and Pasquale Caponnetto and their colleagues at the University of Catania in Italy as a coauthor of a new scientific article on e-cigarettes published in Harm Reduction Journal (available here). We scientifically disprove the stated premise of a recent NPR broadcast (here), “… little is known about the potential health effects [of e-cigarettes].” NPR “expert” Stanton Glantz stated that “e-cigarettes today are the triumph of wishful thinking over data.” Our publication shows that e-cigarettes are the triumph of scientific evidence over feigned ignorance.
For the benefit of members of the Flat Earth Society, I reproduce our summary here:
By Dave Franzman, Reporter
Miller, at a Cedar Rapids news conference, urged lawmakers first to impose a ban on selling the product to minors under the age of 18. E-cigarettes are typically battery operated devices that heat liquid nicotine into a vapor the user inhales. Miller said the e-cigarettes are so new, Iowa law doesn’t adequately address the use.
By Lisa Robbins, Reporter
CHARLESTON, WV – There’s a new push for the federal government to take control of all tobacco products, including flavored cigars and e-cigarettes.According to the Centers for Disease Control, more than 2 out of 5 middle and high school students who smoke use flavored little cigars or flavored cigarettes.
Some lawmakers want the Food and Drug Administration to step in and regulate all tobacco products, specifically flavored ones, which some people think targets teenagers.
Zach Fawley smokes traditional cigarettes, but said he is trying to quit. He agrees the flavored products can draw younger people in.
The State of Massachusetts has established a commissioin to study the impacts of the sale of illicit tobacco products.
SECTION 182. There shall be a special commission to study the economic impact of the illegal tobacco market in the commonwealth which shall consist of: the commissioner of revenue or a designee, who shall serve as the chair; the state treasurer or a designee; 1 member of the house of representatives; 1 member of the senate; the secretary of administration and finance or a designee; the attorney general or a designee; the executive director of the Northeast Association of Wholesale Distributors or a designee; the executive director of the New England Convenience Store Association or a designee; and 1 person to be appointed by the governor.
Editor’s Note: Interactive Public Dockets were developed so as to break the federal monoply over maintaining a regulatory docket. The e-cig community can post comments and file new posts on this IPD to make their case.
Editor’s Note: Listen to the story here.
From: National Public Radio
By Melissa Block
Electronic cigarettes are popping up in more and more stores around the country and consumers are “vaping” in bars and restaurants with gusto. Sales of the devices are expected to reach nearly $2 billion this year. Until now, the top tobacco companies have been out of the game, but both Altria, which owns Phillip Morris, and R.J. Reynolds are now launching their own brands. Back in 2009, the FDA warned that e-cigarettes could pose health risks. This month, the agency is expected to release a set of proposed regulations on the devices.
GAO Criticizes FDA/CTP’s Lack of Performance Measures for Substantial Equivalence Product Submissions
Editor’s Note: The GAO report “NEW TOBACCO PRODUCTS: FDA Needs to Set Time Frames for Its Review Process” is attached here. In the report, GAO recommended “that FDA establish performance measures that include time frames for making decisions on new tobacco product submissions and that the agency monitor performance relative to those time frames.” In HHS’ response to the report, ther Department committed to a series of measures to implement GAO’s recommendations. CRE, a regulatory watchdog, will track and report on FDA/CTP’s response to GAO.
Below is an excerpt from the Department of Health and Human Services comments on the report.
Editor’s Note: The FDA/Center for Tobacco Products response to the Tobacco Control Legal Consortium and affiliated organizations seeking a ban on menthol-flavored cigarettes is attached here. Below is an excerpt from the FDA’s reponse.
“FDA has been unable to reach a decision on your petition because it raises signficant, complex issues requiring extensive review and analysis be Agency officials.”
Jacob Sullum, Contributor
Judging from the comments on my recent post about a fear-mongering WNBC story warning that e-cigarettes encourage drug use by teenagers, I should have more clearly stated what I thought was obvious: I do not agree that “e-cigarettes lead to heroin” (as I sarcastically summarized the story’s message), and WNBC presents no evidence to back up that claim. Instead the station quotes two sources, Nassau County Police Lt. Kevin Smith and Assemblywoman Linda Rosenthal (D-Manhattan), who offer variations on what is known as the “gateway” or “stepping stone” theory of drug use. “For young people, marijuana is a gateway,” says Smith, decrying the use of e-cigarettes to consume marijuana extracts. “The next thing you know they’re doing acid, molly, even heroin.” Rosenthal says it starts with nicotine rather than marijuana: “Once you try electronic cigarettes, you can become hooked to them, move on to cigarettes and then move on to other drugs.”
Editor- Atlanta Business Chronicle
A possible crack down on menthol cigarettes by the Food and Drug Administration could spur a new market for contraband smokes sold by “rogue retailers,” the Georgia Association of Convenience Stores is warning.
In July, the FDA launched a review of menthol cigarettes, saying “menthol cigarettes raise critical public health questions,” inviting public comment as to what actions it might take.
In a letter to the FDA made public Oct. 8, Jim Tudor, president of the Georgia Association of Convenience Stores, says an FDA crackdown could hurt the more than 2,500 stores in Georgia that the organization represents.
FDA: The issuance of three substantial equivalence orders for Republic Tobacco Company products is an activity that is funded under FDA’s user fee program in the Center for Tobacco Products (CTP). Some FDA activities that do not rely on annual appropriations are continuing during the government shutdown.
Today, the U.S. Food and Drug Administration (FDA) announced that the Agency is authorizing the sale and marketing of three additional tobacco products through the substantial equivalence pathway. As directed by the Family Smoking Prevention and Tobacco Control Act, FDA has a responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review.
From: New York Times
By ANDREW HIGGINS
STRASBOURG, France — In a decision likely to resonate in the United States and other countries struggling to get a grip on a galloping market for e-cigarettes, the European Parliament on Tuesday scrapped health officials’ proposals that the nicotine-delivery devices be tightly regulated as medical devices.
Instead, lawmakers endorsed a more permissive approach to their sale and use, although the products could not be sold to anyone younger than 18.
CRE’s comments to the FDA on their “Menthol in Cigarettes” Advance Notice of Proposed Rulemaking (ANPRM) document in detail many of the public health harms to children and other vulnerable populations from tobacco trafficking. The comments also estimate the countervailing increase in the black market for menthol cigarettes that would ocurr if the FDA were to ban their sale.
Electronic cigarettes, or e-cigarettes, provide a water vapor-powered alternative to traditional smoking that may help users drop the unhealthy habit. But, in light of the recent finding that use among middle and high school students is rapidly increasing, the Food and Drug Administration (FDA) has indicated that a new regulatory regime to manage these novel products more effectively is on the horizon.
From: The Spectator
What strategy should we adopt to cope with the British Medical Association? Its members kill more people each year than President Assad — 72,000 is the latest estimate, from the House of Commons health select committee. Perhaps it is at last time to sit down and negotiate with them, much though this will stick in the craw, like a misplaced scalpel. We say that organisations like the IRA and the BMA will ‘never win’ and that we will ‘never negotiate’ – but this is empty rhetoric, because we always end up doing so. If we could just reduce by 10 per cent the number of people killed every year through medical errors it would at least bring the figure below the combined annual deaths attributed to smoking and drinking and obesity. That’s something to aim for, isn’t it? Attempt to find some common ground with the more moderate elements and then persuade them to put down their weapons. It could work, it could work.
From: The Hill
By Julian Hattem
A group of House Democrats is calling on the Obama administration to issue new rules for cigars and electronic cigarettes.
In a letter to the Food and Drug Administration (FDA) on Monday, the lawmakers asked regulators “to act quickly” with new rules for the products, over which the federal government currently has little oversight.
“Manufacturers of e-cigarettes are taking advantage of this regulatory loophole to target children,” wrote Reps. Henry Waxman (D-Calif.), Diana DeGette (D-Colo.), Frank Pallone Jr. (D-N.J.) and John Dingell (D-Mich.). “As a result, some e-cigarette makers are producing products with kid-friendly flavors such as ‘Cherry Crush’ and ‘Cookies & Cream Milkshake.’ ”
Stop—a ban on menthol cigarettes—in the name of the law!
A number of current and former top-ranking law enforcement officials from the tobacco-producing South have blasted a potential menthol cigarette ban as the Food and Drug Administration weighs restrictions on those products, contending that prohibition will spur smuggling, counterfeit cigs and other organized crime.
Their comments to the FDA mirror arguments being made by Big Tobacco companies that have cited the specter of a menthol black market.
IS THE rising popularity of electronic cigarettes a public health problem or a way for smokers to get their nicotine in a safer form? Right now, e-cigarettes appear to be both.
The Centers for Disease Control and Prevention (CDC) last week announced that the number of youth who have tried e-cigarettes doubled between 2011 and 2012. One-tenth of high school students inhaled the devices’ vapor last year. About three-quarters of those who admitted using e-cigarettes currently also smoked traditional cigarettes. But roughly 160,000 students in the National Youth Tobacco Survey last year said they had tried only e-cigarettes.
“Illicit Cigarette Markets Are A Significant Problem Today, and Will Worsen if Menthol Cigarettes are Outlawed.”
Editor’s Note: The comments of NACS The Association for Convenience and Fuel Retailing in response to the FDA’s Advance Notice of Proposed Rulemaking (ANPRM) on menthol in cigarettes are attached here. The Conclusion of NACS comments to FDA are reprinted below.
NACS encourages the FDA to undertake a thorough analysis of the potential for an illicit market, its potential size and the degree to which it would impact public health and jobs. We hope that the FDA will not be satisfied with simply receiving responses as part of the ANPRM process. Instead, we urge the FDA to assemble the responses of NACS and others to develop a robust research agenda into the existence today of illicit markets, the impact on youth smoking, the ingredients in counterfeit cigarettes and other issues.
The CRE website was attacked with the result that had we not pulled down the website we would have risked loosing content.
We appreciate your many emails and we are working to continue to install state of the art early warning systems. We must , however, add that we have only had two major outages in more than a decade of operation.
We are particularly concerned that some of you could not use the website for the preparation of regulatory filings.
The comments attached here were submitted to the FDA’s Menthol ANPRM docket by Multinational Business Services, Inc. MBS explained in their comments, based on the peer reviewed literature, that
In addition to harming younger people, the contraband cigarette trade also disproportionately impacts lower income and non-white citizens.
MBS concluded, in part, that the likely impacts of a menthol ban would include:
• More criminals selling cigarettes to children – contraband dealers don’t adhere to age restrictions;
• More contraband cigarettes with extreme levels of lead, cadmium and other toxics as well as potentially higher levels of nicotine; and
From: Los Angeles Times
E-cigarettes, a trendy alternative to smoking, are legal and little studied, but their use is being curbed in some places, just in case.
By Adolfo Flores and Marisa Gerber
Saturday was supposed to be a big day for Billy DePalma.
He envisioned a ribbon cutting and then a steady stream of new customers perusing colorful, pen-shaped electronic cigarettes behind glass cases. They’d gawk at his impressive selection of liquid nicotine — flavors like Hubba Bubba Grape, Gummy Bear and Orange Cream Soda — as he fielded questions about the fast-growing trend of “vaping,” so-called because users inhale the vapor produced when the liquid is heated.
Cigarettes kill, but menthol isn’t the culprit. Nevertheless the Food and Drug Administration is moving toward regulating, maybe even banning, menthol in cigarettes, while leaving cigarettes without the minty, cool additive available for public consumption. That makes no sense.
OK, it makes a little sense. Just not enough to justify banning menthol smokes.
More than 440,000 people in the United States die every year due to tobacco use, according to the FDA, which nailed tobacco as the nation’s leading cause of preventable death and disease. But the agency found no evidence that menthol cigarettes are more toxic than non-menthol brands, or pose a heightened risk of disease for smokers.
The FDA wants to correct inaccuracies in an August 22, 2013 article in the Wall Street Journal, titled “FDA Discusses Banning Online Sales of E-Cigarettes.”
The FDA frequently meets with members of the tobacco industry, as well as with public health groups and other stakeholders, to better understand any concerns or questions they may have. As part of this effort, “listening sessions” with e-cigarette companies have been held at their request and have given the FDA an opportunity to listen to their concerns or views.
From: Science Daily
With the third and largest of the U.S. tobacco companies planning an e-cigarette product launch this fall, this next frontier for “Big Tobacco” provides renewed presence in a declining marketplace. It’s also a potential gateway to new smokers, particularly among teens and in emerging/foreign markets, according to behavioral scientists at The University of Texas MD Anderson Cancer Center.
E-cigarettes are battery-powered devices that provide inhaled doses of nicotine vapors and flavorings. The Centers for Disease Control and Prevention estimates that about 6 percent of adults have tried e-cigarettes, a number that has nearly doubled since 2010. Absent of tobacco, e-cigarettes have been promoted as a possible aid in getting people to stop smoking and thereby reducing their lung cancer risk.
Also issues 10,000th tobacco retailer warning letter
WASHINGTON — The U.S. Food & Drug Administration’s (FDA) tobacco compliance and enforcement program–touting that it recently issued its 10,000th tobacco retailer warning letter–has also issued warning letters to three tobacco manufacturers and one tobacco retailer for promoting or selling illegal cigarette or roll-your-own (RYO) tobacco products labeled as “pipe tobacco.”
These tobacco products were found to be subject to FDA regulation, and as such, the warning letters include violations for selling modified-risk tobacco products without an order in effect or selling prohibited flavored cigarette tobacco products, the agency said in a press release.
Editor’s Note: CRE applauds FDA actions to control adulertated tobacco products. However we encourage FDA to go a step farther and respond to CRE requests to address the adverse health effects of counterfeit cigarettes.
Press Trust of India | Updated: August 11, 2013 14:15 IST
In a warning letter issued to the two websites, the Food and Drug Administration (FDA) said that their several products have been found to be “adulterated” under relevant regulations and did not carry the required permits for sale in the US.
The Risk Communication Advisory Committee ( RCAC ) is meeting separately and also jointly with TPSAC. The RCAC meeting focuses on the adverse health impacts of counterfeit drugs; the TPSAC meeting focuses on harmful and potentially harmful constituents (HPHCs} of legitimate cigarettes.
Why not eliminate the silo effect and spend some time on the adverse health impacts of counterfeit cigarettes?
TPSAC has never addressed this topic notwithstanding public comments supporting their addressing this important public policy issue.
In the attached document CRE delineates the well established public threat to the public in general, and to juveniles in particular, associated with the counterfeit cigarettes.
From: Associated Press
By MICHAEL FELBERBAUM
RICHMOND, Va. – Companies vying for a stake in the fast-growing electronic cigarette business are reviving decades-old marketing tactics the tobacco industry has used.
They are using cab-top and bus stop displays and sponsoring race cars, while encouraging smokers to “rise from the ashes” and take back their freedom in slick TV commercials featuring celebrities like Jenny McCarthy.
The FDA plans to set marketing and product regulations for electronic cigarettes in the future. But for now, almost anything goes. “Right now it’s the wild, wild west,” said Mitch Zeller of the FDA’s Center for Tobacco Products.
UC Riverside’s Rachel Behar will study the effects of electronic cigarette aerosols on cell health
By Philip Vieira
RIVERSIDE, Calif. — Ever since e-cigarettes hit the market in 2004, they have been advertised as an aid for cigarette smoking cessation. The aerosols produced by e-cigarettes, however, have yet to be screened for potential health risks.
RICHMOND, Va. — A Food and Drug Administration review concludes that menthol cigarettes likely pose a greater public health risk than regular cigarettes but does not make a recommendation on whether to limit or ban the minty smokes — one of the few growth sectors of the shrinking cigarette business.
The federal agency released the independent review on Tuesday and is seeking input from the health community, the tobacco industry and others on possible restrictions on the mint-flavored cigarettes.
University of Hawaii Cancer Center Prevention and Control Program researchers Pallav Pokhrel, PhD and Thaddeus Herzog, PhD have found that smokers who use e-cigarettes as a tool to stop smoking tend to be younger and more motivated to quit smoking as compared to other smokers.
Their study published online ahead of the print version in the American Journal of Public Health, found that approximately 13 percent of smokers had tried e-cigarettes as a means of quitting smoking. They also found that smokers who had tried e-cigarettes for smoking cessation help were younger and had been smoking for fewer years compared to other smokers.
This week, the Food and Drug Administration (FDA) released an updated version of the agency’s “Unified Agenda” indicating that the Center for Tobacco Products (CTP) intends to issue a Notice of Proposed Rulemaking by October 2013 on other products that fall within the definition of tobacco products under the Family Smoking Prevention and Tobacco Control Act.
This means that the FDA plans to issue proposed regulations on other tobacco products that may include cigars, pipe tobacco or electronic products such as electronic cigarettes and electronic cigars. Currently, the FDA regulates traditional cigarettes, roll-your-own (RYO) tobacco products and smokeless tobacco products.
By William Kremer
Dozens of countries are introducing legislation restricting the use of electronic cigarettes, but their proponents say they are harmless and their use could in fact save millions of lives. Could they be right?
A group of friends sits around a table in a pub in south London, exchanging stories and putting the world to rights in a cloud of scented vapour.
One of them is 31-year-old Jonny Lavery.
“I had a big problem with death, a really big problem with dying,” he says. “I wanted to avoid dying at all costs.”
By Dave B. Clissold –FDA Law Blog
Earlier this week, FDA’s Center for Tobacco Products (“CTP”) released its first determinations regarding the marketing of new tobacco products through the substantial equivalence (SE) pathway. CTP authorized the marketing of two new tobacco products and denied the marketing of four others. Under the Family Smoking Prevention and Tobacco Control Act of 2009, one way manufacturers can legally sell a new tobacco product is to establish that their product is substantially equivalent to a predicate product that has been marketed at least since February 15, 2007 (for more on the SE pathway, see our previous posts here and here). Before marketing the new product, the manufacturer must submit a SE Report under Section 905(j) of the Federal Food, Drug, and Cosmetic Act. If the new and predicate products have different characteristics, the SE Report must demonstrate that the new product will not raise new questions of public health compared with the predicate product. After reviewing the SE Reports for two Lorillard Tobacco Company cigarette products, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box, CTP issued each a SE Marketing Order.
From: USA Today
Look at any electronic cigarette company’s website, and you’ll read that you can smoke the battery-operated devices almost anywhere.
Up until recently, Blu eCigs boasted on its website that one benefit over traditional cigarettes is that you can “Smoke anywhere!” The website has since toned down its language to say that you can “Smoke in many places where traditional cigarettes aren’t allowed!”
The confusion about where you can or cannot smoke e-cigarettes has posed a challenge for the travel industry. The FDA has not ruled on the safety of e-cigarettes, but the agency will propose a rule on how to regulate them down the road.
From: New York Times Editorial
Rapidly growing numbers of consumers are turning to electronic cigarettes to satisfy their nicotine addiction without inhaling the carcinogens and toxic chemicals found in tobacco smoke. Buyers need to beware. Unlike nicotine gum and skin patches, electronic cigarettes have not been evaluated for safety or effectiveness.
Global sales of electronic cigarettes, although small compared with overall tobacco sales, have been rising quickly in both Europe and the United States. Several major tobacco companies have announced plans to introduce new or revamped e-cigarettes. And regulators for the European Union and Britain have released plans to regulate e-cigarettes more stringently, possibly starting in 2016.
When the U.S. Food and Drug Administration (FDA) imposes new graphic warning labels for tobacco products, they can survive a First Amendment challenge if they depict health consequences and their effectiveness is supported by adequate scientific evidence, says a Georgetown University Medical Center public health expert and attorney
Graphic tobacco warning labels—which combine images with health warnings—are a widely used tool for reducing tobacco use in other countries, but the tobacco industry argues they are unconstitutional in the United States.
By Albertina Torsoli & Makiko Kitamura
Just when smokers thought it was okay to inhale again, a debate over the safety of electronic-cigarettes is threatening to cut off their nicotine.
Smokeless and odorless e-cigarettes are catching on, touted in the U.S. and Europe as less harmful than real ones because they don’t contain tar, arsenic and other cancer-causing toxins. Yet a U.K. government decision this week to treat the steel tubes as a medicine and a plan by France to ban them from public venues raises questions about what health risks the devices carry.
By Michael Gormley of The Associated Press
“If New York acts, it would be the first state in the nation, and turbocharge efforts nationally,” said Blair Horner, vice president of advocacy at the American Cancer Society and Cancer Action Network of New York and New Jersey.
ALBANY, N.Y. — First came Mayor Michael Bloomberg’s proposal to ban tobacco displays in New York City. Then, both New York City and state introduced legislation to raise the age to purchase tobacco products to 21. Now, the American Cancer Society is pushing for New York to become the first state to restrict the sales of all flavored tobacco products (although New York City and Providence, R.I., have already banned the sales of such products).
By Justin Bachman
The electronic cigarette is about to have its turn in the spotlight. The battery-powered gadgets transform nicotine and other substances into an inhaled vapor and have been marketed as a safer alternative to tobacco smoke, which is drawn into the lungs and increases cancer risks. The rapidly growing e-cigarette business—expected to top $1 billion in annual sales in the next few years—is racing to command a bigger share of spending among smokers and potential smokers ahead of possible regulations from the U.S. Food and Drug Administration.
Editor’s Note: The Tobacco Vapor Electronic Cigarette Association’s Position Paper, “E-cigarettes in the Draft Revised Tobacco Product Directive: Avoiding a ban on a less harmful alternative” is attached here.
From: Medical Daily
French health officials announced future plans to ban smoking electronic cigarettes in public places and to restrict sales to minors.
By Justin Caba
Health officials in France have revealed plans to ban electronic cigarettes from all public settings and put restrictions on advertising. French Health Minister, Marisol Touraine, stated on Friday efforts will be similar to the 2007 initiative aimed toward lowering the number of regular tobacco users.
Editor’s Note: The French government study, “Rapport et avis d’experts sur l’e-cigarette,” discussed in the article below is attached here. The initial step in evaluating the report would be to determine if it complies with the Data Quality Act and implementing guidance. As HHS has already recognized, international studies are required to meet the same quality standards as all data considered by agencies.
By Albertina Torsoli
Use of electronic cigarettes in public spaces such as restaurants should be forbidden, French researchers wrote in a government-commissioned report.
FDA tobacco chief speaks at industry meeting
Zeller said the agency is aware that certain products could reduce individual health risks. But he said the 2009 law giving the agency authority to regulate the industry requires that it measure health effects at a population level.
By Thomas A. Briant
With the continued growth of the e-cigarette category in terms of the number of e-cigarette manufacturers, the number of brands on the market, and the increasing consumer demand for electronic cigarettes, state lawmakers have also begun to consider bills to tax e-cigarettes and prevent the sale of the products to underage youth. All of this state legislation is being considered within a potential federal regulatory framework to regulate electronic cigarettes that the U.S. Food and Drug Administration should announce in the near future.
E-Cigarette Tax Bills
COLUMBIA – Ron Sena of Charleston saw his first electronic cigarette while on a cruise with his wife.
A smoker for 40 years, Sena was aware of the regulations surrounding smoking in restaurants, so he was surprised when a man pulled out what looked to be a cigarette in the dining room.
From: Associated Press
FDA tobacco chief says health community grappling with idea that some products are less risky
WILLIAMSBURG, Va. — Changes in the marketplace have forced the public health community to wrestle with the idea that some tobacco products may pose less of a health risk than others, the new head of the Food and Drug Administration’s tobacco control efforts told an industry group on Thursday.
FDA details barriers for submitting SE, MRTP and New Tobacco Product applications, falsely claims agency’s goal is to reduce morbidity and mortality
e cigarette Forum
Title of article by FDA’s former CTFP director Lawrence Deyton and DHHS’ Corinne Husten falsely claims FDA‘s goal is to reduce tobacco morbidity and mortality, but then delineates many unwarranted and expensive barriers (i.e. SE, MRTP and New Product guidances) the agency has issued that effectively ban new smokeless tobacco products, and prevent smokers from being truthfully informed that smokefree alternatives are far less hazardous than cigarettes.
Understanding the Tobacco Control Act: efforts by the US Food and Drug Administration to make tobacco-related morbidity and mortality part of the USA’s past, not its future
New rules from Brussels effectively banning low-risk alternatives to cigarettes, like e-cigs, will cost lives.
In December 2012, the EU’s executive, the European Commission, announced its proposals to revise the Tobacco Products Directive (TPD), originally passed in 2001, to take account of ‘significant scientific, market and international developments’ that have taken place since. But far from improving Europeans’ health, the proposals as they stand could well lead to many thousands, perhaps millions, of unnecessary early deaths.
From: San Francisco Chronicle
There are a lot of public health questions surrounding the use of e-cigarettes, but one thing is not in question – they are becoming a popular alternative to tobacco cigarettes. One in 5 smokers in the United States had tried e-cigarettes in 2011 – up from 1 in 10 in 2010, according to the Centers for Disease Control and Prevention.
E-cigarettes, battery-powered devices that vaporize liquid nicotine so people can inhale it, began appearing in U.S. stores in 2007. They contain fewer hazardous chemicals than tobacco cigarettes but are so new that no long-term studies have been done to determine the health effects both for smokers and those who breathe in the vapors secondhand.
From: WECT Channel 6
EW HANOVER COUNTY, NC (WECT) – Electronic cigarettes are gaining popularity among smokers, but not all employers are on board with the idea.
More and more companies are creating policies for using the smoking alternative at work.
E-cigarettes are not allowed anywhere at New Hanover Regional Medical Center – and that goes for employees too. A spokesperson for the hospital said administrators recently notified staff about this change.
Health warnings from the FDA prompted the change, according to a hospital spokesperson.
Employees with New Hanover County government are under the same restrictions. E-cigarettes are lumped in with the county’s larger tobacco policy.
A suit brought by tobacco companies challenging new regulations which require them to display large, graphic warnings on cigarette packages will not be heard by the Supreme Court, reports The Hill.
The companies dispute the legality of a 2009 tobacco law, demanding that half of every pack of cigarettes is covered with an image and government-approved text warning of the deleterious health effects of tobacco use.
Don’t expect to see the new labels just yet. An appeals court previously blocked the labeling effort and that decision still stands, according to the U.S. News and World Report. According to the ruling, the FDA must prove that such a labeling effort will correlate with reduced smoking rates
MANILA, Philippines—It would seem that electronic cigarettes, which is being promoted as a healthier substitute for tobacco, may just be as harmful as the real thing.
The Food and Drug Administration (FDA) on Friday warned the public against e-cigarettes, saying they cannot be considered legitimate therapy for smokers to quit and that they could turn children into smokers.
E-cigarettes have been gaining favor among Filipinos as higher tobacco taxes make smoking more expensive.
Although the long-term health effects of electronic cigarettes are unknown, a new survey finds people who use the devices think of them as a safer alternative to tobacco and a means to break the smoking habit.
Researchers from the UK surveyed about 1,400 e-cigarette users on the Internet, 76 percent of whom said they started using their devices to replace cigarettes entirely. A much smaller percentage said their goal was to quit smoking or to improve their health.
One researcher who has studied e-cigarette users said the findings allay fears that people are using the devices to get more nicotine on top of what’s already in tobacco cigarettes, instead of for smoking cessation.
By Jacob Hale Russell
(Reuters) – The Federal Drug Administration is considering a recommendation that an independent body should monitor some research put to the agency by tobacco companies, underscoring the growing concern about conflicts of interest in scientific research.
The recommendation was submitted by the Institute of Medicine, a scientific research organization that’s part of the National Academy of Sciences, and is based on its 2011 report. It suggests that any research provided to the FDA by manufacturers of so-called modified-risk tobacco products, which companies want to market as “less” risky, should be overseen by an independent body.
Big Tobacco Companies Breathing Sigh of Relief After FDA Drops Graphic Warning Labels for Cigarettes
Big tobacco companies are breathing a sigh of relief Friday morning.
The Food and Drug Administration (FDA) has scrapped a series of graphic warning labels for cigarettes.
It’s decided not to challenge a court ruling which said the shocking images violated free speech protections.
Attorney General Eric Holder says the FDA will propose new labels. However, that could take a few years.
By Ben Goad
The Food and Drug Administration (FDA) is considerating of a series of year-old regulatory recommendations issued by a coalition of tobacco companies.
Beginning Tuesday, interested parties and members of the public will have 60 days to consider the proposal submitted to FDA in January of last year. The recommendations relate to manufacturing practices and the industry’s interpretation of existing regulations, according to a notice to be published in the federal register.
A docket will be created for comments and related materials, including the proposal, here.
Editor’s Note: The author of the following article concludes:
“The FDA has done an admirable job – to date – resisting the entreaties of anti-tobacco protesters to use the legislation as a vehicle for a full on assault on cigarette makers.”
We agree and suggest that all stakeholders express their support for FDA’s insistence on basing decisions on sound science. However CRE is very concerned about the following statement:
” Activists have managed to infiltrate the middle ranks of the agency’s center“
British American Tobacco Plc (BATS) said it may sell an alternative nicotine product in the U.K. as early as next year, as Europe’s largest cigarette maker moves to counter stricter global restrictions on smoking.
The maker of Lucky Strikes is expecting approval for a new “tobacco inhalation device” that is not an electronic cigarette by the end of this year and it could be “ready to launch some time in 2014, if not, 2015,” Kingsley Wheaton, BAT’s director of corporate and regulatory affairs, said in a telephone interview today.
By Associated Press,
Mitch Zeller will become the center’s director on March 4, FDA Commissioner Margaret Hamburg said in an internal memo sent late Thursday and confirmed by The Associated Press.
The center was created following a 2009 law gave the FDA authority to regulate a number of aspects of tobacco marketing and manufacturing, though the agency cannot ban nicotine or cigarettes outright. Its first chief, Dr. Lawrence Deyton, plans to step down and become a professor of medicine and health policy at George Washington University, Hamburg said.
American Lung Association Protests Against the Promotion of Smoking Cessation; Why Does the ALA Want to Deny Smokers the Opportunity to Quit?
Professor Michael Siegel
The Rest of the Story
In an op-ed published in the Arizona Republic, the Southwest chapter of the American Lung Association has called for a federal ban on the television advertising of electronic cigarettes, protesting against an ad that appeared in the Phoenix area during the Super Bowl and urging the FDA to ban such ads in the future.
OHS Occupational Health and Safety
Four labels already are required that warn of oral cancer and addiction, but the agency has established a public docket to accept comments on how to increase public understanding of the risks.
The U.S. Food and Drug Administration soon may require stronger warnings on smokeless tobacco products. The agency has established a public docket to accept comments on how to increase public understanding of the risks.
Comments may be submitted via http://www.regulations.gov (Docket No. FDA-2012-N-1032) for the next 60 days.
Last May, New York City banned smoking in parks, beaches, boardwalks and pedestrian plazas. Mayor Bloomberg said, “When you ask people in our parks and beaches they say they just don’t want smokers there.”
White Smoke Review
Perhaps one of the most controversial gadgets today is the electronic cigarette. These electronic cigarettes, or also more commonly referred to as e-cigarettes or e-cigs, are considered to be by some as the best alternative to smoking.
Editor’s Note: Third-party governance could take many directions ranging from streamlining the process to adding another layer of bureaucracy.
Center for Tobacco Products
9200 Corporate Blvd.
Rockville, MD 20850
The purpose of the workshop is to discuss the recommendation in the Institute of Medicine’s report, “Scientific Standards for Studies on Modified Risk Tobacco Products,” that sponsors of Modified Risk Tobacco Product (MRTP) applications use independent third parties to undertake one or more key functions in tobacco product research (third party governance). FDA is also considering third party governance as it relates more generally to tobacco research. Our goal is to receive input from interested stakeholders regarding features from existing third party governance models that may be applicable to tobacco product research.
In the Jan. 8, 2013, Tobacco E-News bulletin, NATO reported that the Food and Drug Administration had released its annual Regulatory Agenda, which states that the agency intends to issue a proposed rule to regulate other tobacco products sometime by April of 2013. While the FDA stated its intention to release proposed regulations on other tobacco products by April of this year, there are various steps that a federal agency needs to follow in drafting, proposing, obtaining public feedback and finalizing a new regulation.
It’s been only a few years since Congress granted the federal government the power to approve how tobacco products are made and sold in the U.S.
The Food and Drug Administration’s new Center for Tobacco Products, established under a 2009 law that gives the agency jurisdiction over tobacco, must review all new cigarettes or smokeless tobacco, as well as any changes to existing brands.
But the agency has yet to clear any products under the new system, and some cigarette makers are frustrated by the backlog of applications.
U.S. District Court Judge Richard Leon has allowed a lawsuit seeking an injunction by R.J. Reynolds and Lorillard Tobacco to proceed against the Tobacco Products Scientific Advisory Committee. It alleges a conflict of interest on the scientific panel responsible for regulating tobacco products.
FDA officials asked Judge Leon to deny the request but the judge rebuffed their claim, noting in his ruling “the limited number of viewpoints on these issues” and “the scientific as opposed to the political nature of those viewpoints, and the distinct responsibilities of the committee.”
Editor’s Note: The issue is not wheher e-cigs are safe but whether they are safer than cigarettes. Nothing in the following article suggests that e-cigs are not a safe alternative to cigarettes.
Editor’s Note: Mr Raeburn’s criticism is somewhat misplaced because a significant number of the submissions to the FDA for new products are not available to the public until which time the FDA has reviewed them and initiated a proceeding. In addition Felberbaum’s statement was that historically, prior to the new Act, that the tobacco industry introduced considerably more products than after the Act. If you compare any positive number with zero, the resultant analysis follows.
Knight Journalism Tracker MIT
A story by Michael Felberbaum at The Associated Press on delays in FDA approval of new tobacco products sticks far closer than it should to the industry position on the delays.
If you like e-cigarette smokers, possibilities t hat you don’t know how this item works a’nd how it is different from the conventional tobacco. A sensible ustomer know the primary information about the item which he is using so that he can appreciate its benefits. When you are purchased e-cigarette, you must be sure you are no longer in the black as to the benefits it has over the conventional tobacco.
The court’s decision sets up a potential Supreme Court showdown with Big Tobacco.
A federal appeals court on Wednesday rejected the government’s request for the full court to hear a case on the Food and Drug Administration’s graphic tobacco warning labels, setting up a potential Supreme Court showdown with Big Tobacco.
But first, the government has to decide whether it wants to defend the labels it developed or go back to the drawing board.
The Department of Justice has 90 days to appeal the case to the high court. A spokesman declined to comment on whether it would.
St Louis Dispatch
Editor’s Note: There are a number of studies which demonstrate that smokeless tobacco present less risk than direct smoking. Whether or not the authors of the following article agree with the studies the studies should be analyzed and the readers should be advised of their infrimities.
ASCO has joined with other anti-tobacco stakeholder groups in urging the Food and Drug Administration to deny a petition by R.J. Reynolds Tobacco Co. to alter warning labels on smokeless tobacco products. The company’s petition asks FDA to change the language on products, noting that smokeless tobacco “presents substantially lower risks to health than cigarettes.”
I respect the motives of those who wish to raise Maryland’s cigarette tax (“Activists want dollar boost in cigarette taxes,” Nov. 15). However, such an increase would make it increasingly worthwhile for Maryland smokers to travel to neighboring, lower-tax state for their purchases.
The priority should be a on fairer, more effective way to reduce cigarette smoking — by raising the legal tobacco age to 21. That would interpose three more years of maturity, and three more years’ receipt of society’s widespread anti-tobacco messages, before young people could legally buy cigarettes. That could lead to a major reduction in number of young adults who smoke.
“Electronic cigarettes could ‘damage your lungs’ as they cause less oxygen to be absorbed by the blood,” reports the Daily Mail.
The news is based on a press release of preliminary findings of a small study investigating the short-term effects of smoking an ‘e-cigarette’, commonly known as ‘vaping’. The study looked at the lung function of non-smokers and smokers with and without lung conditions.
According to the press release, researchers found that ‘smoking’ a single e-cigarette for 10 minutes caused an increase in airway resistance, blocking the air getting into and out of the lungs.
Editor’s Note: As in all statements made by CRE they are all presented on an Interactive Public Docket which allows the public to offer their views on the subjects presented herein.
This afternoon the Public Health Law Center of the William Mitchell College of Law held a webinar titled “Pressing the FDA on Menthol”
The Presenters included:
•Ellen Vargyas – General Counsel and Corporate Secretary at American Legacy Foundation
•Dr. Philip S. Gardiner – Social & Behavioral Sciences and Neurosciences and Nicotine Dependence Research Administrator for the Tobacco Related Disease Research Program, Universityof CaliforniaOffice of the President
Bruce Hendren stands in front of his $32,000 cigarette rolling machine at Roll On on Tuesday. The machine is capable of rolling a carton of cigarettes with fresh tobacco in about 10 minutes. A July 2012 Highway bill had a small amendment attached that labeled Hendren a cigarette manufacturer, so he has ceased use of the machine. ¦ Kayla Kauffman
COLUMBIA — June 28 marked the one-year anniversary for downtown tobacco store Roll On, which caters to customers who like to customize their cigarettes.
Owner Bruce Hendren’s excitement ended that day when he answered his phone.
Tennessee Violation Rate Lower Than National Averag
Tennessee had a 4.06% violation rate in those two years which is below the national average of 4.93%. Click HERE for the details of the We Card data.
American Cancer Society
One of the largest makers of e-cigarettes in the Chinese mainland has announced that it will be shipping its brands to retailing outlets in the US, with their charges at a peak low, due to their determination to penetrate the market using coupons.
This comes at a time when executives of various electronic cigarettes’ companies are acknowledging the fact that more people than ever before are going to avail these vapor-emitting tobacco pipe-lookalikes as their holiday gifts.
Channel 4 England
This month is Stoptober, a £6m Department of Health campaign to help people to quit smoking within 28 days. Health experts believe that if they can achieve that they are five times more likely to quit the habit for good.
Persuading people to stop smoking is what anti-tobacco groups describe as the holy grail. Yet next week, there will be what amounts to an official acknowledgment that sometimes it is simply impossible to persuade some smokers to quit so, instead, there needs to be harm reduction.
Editor’s Note: The problem with the Baltimore Sun’s argument is that tobacco is a legal product; if the government is going to impose conditions on its sale, the government mandates must generate benefits to the public. In the said instance not such benefits were forthccoming.
Our view: If FDA can’t require graphic photos and more compelling warnings on cigarette labels, lives will be shortened for the sake of tobacco’s ‘right’ to profit
Join Together Staff
The U.S. Justice Department has asked a federal appeals court to rehear a case about the Food and Drug Administration’s (FDA) requirement that tobacco companies place graphic labels on cigarette packages to warn about smoking’s health dangers. In August, a three-judge appeals court panel affirmed a lower court ruling that blocked the mandate.
The Justice Department is asking the full appeals court to rehear the case, USA Today reports. The U.S. Court of Appeals in Washington rarely grants such appeals, the newspaper notes.
Americans purchased 636.5 billion cigarettes way back in 1981. A good chunk of them were likely sucked in by the slew of air-traffic controllers that President Reagan fired. Or maybe it was all the people coming out of the year’s fifth most-popular film, “Cheech and Chong’s Nice Dreams.” Or those taking a break after getting down to Kool & the Gang’s “Celebration.”
It’s hard to know just where all those cigarettes were going, but that year found Americans purchasing more of the so-called cancer sticks than any other. Since then, of course, there has been a long battle to help people ditch tobacco products in the hopes of bringing down the numbers of death from cancer.
Robert Wood Johnson Foundation
Last month at the Association of State and Territorial Health Officials Annual Meeting (ASTHO), attendees focused during one session on the progress made in reducing tobacco death and disease—and the significant room for improvement, as tobacco remains the leading cause of preventable death in the United States.
We caught up with Lawrence Deyton, MSPH, MD, director of the Food and Drug Administration’s (FDA) Center for Tobacco Products at the ASTHO meeting to get his take on the value of tobacco control as a prevention strategy, as well as the role of state and local public health officials.
The FDA is publishing Federal Register notices seeking nominations for voting members of the TPSAC and for non-voting industry representatives to serve on the TPSAC.
The FDA notice for Voting members is attached here, Voting-TPSAC
The FDA notice for Non-Voting industry representatives is attached here, Nonvoting-TPSAC.
by Kirk Hawkins
CHARLOTTE, N.C.–Camel’s Orbs are smokeless tobacco products available on store shelves across the Charlotte area. The Food & Drug Administration is looking to regulate these and other cigarette alternatives because they say they are marketed to kids.
“By decreasing the size of the cigars and adding flavors to it, the tobacco companies hope to get more people addicted to their products,” said Selay Demir. A senior at Myers Park High School. Demir has been working toward a tobacco free North Carolina with Youth Empowered Solutions since the parents of two close friends passed away. “They never used any type of tobacco product in their life and their death was the result of people who had been smoking,” Demir said.
MIAMI — Six months after forming, the Smoke-Free Alternatives Trade Association (SFATA) will make its national debut at the 2012 NACS Show. The association in the smoke-free alternatives industry came together in March and represents distributors, manufacturers, retailers, and end users with the goal to address a variety of consumer matters including tobacco regulation and its possible extension to vaporizing devices, according to SFATA.
Editor’s Note: Described below is another shortsighted regulatory regime which will increase the sale of counterfeit cigarettes and the resultant adverse health effects.
Australia strikes first in move to ban individual branding
LONDON (MarketWatch)—Cigarette makers are bracing for a potential drop in demand and a fierce price war, after Big Tobacco failed to overturn an Australian law last month calling for plain wrapping on their products.
Since then, fear has mounted that generic packaging will not only hurt the premium brands that rely on distinct branding but will also trigger an illicit, counterfeit trade that will have major implications across the entire industry.
Campaign for Tobacco-Free Kids’ Argument that Sixth Circuit Validated Graphic Warning Labels is Not Entirely Correct;
Dr. Micahel Siegel
Campaign for Tobacco-Free Kids’ Argument that Sixth Circuit Validated Graphic Warning Labels is Not Entirely Correct; Supreme Court Will Never Affirm Sixth Circuit’s Reasoning on the Actual Proposed Warning Labels
Last month, I reported on the U.S. Court of Appeals for the District of Columbia upholding a district court decision that invalidated the graphic cigarette warning labels proposed by the Food and Drug Administration (FDA).
The Campaign for Tobacco-Free Kids has argued that the D.C. Circuit’s ruling is “wrong on the law” and “wrong on the science” and urged the FDA to appeal to the Supreme Court.
Despite a sharp increase in the number of “no” violations among retailers selling alcohol, the violation rate among the total retailer universe drops from 2011.
ARLINGTON, VA – The FDA’s Center for Tobacco Compliance (CTP) has updated its compliance check enforcement activity of retailers selling tobacco, which reveals a sharp increase in the number of compliance checks.
An analysis of CTP data by the We Card Program, which uses publicly available data at fda.gov, the 2012 totals and rates (through August 31) are as follows:
There exists, in some lawyer’s vault, somewhere in the United States, a secret memo that was authored by a tobacco company executive back in 1955. Written in the exclamatory patois of the time, it says, “Boy! Wouldn’t it be wonderful if our company was first to produce a cancer-free cigarette. What we could do to the competition.”
Editor’s Note: The study described below alleges certain downsides to e-cigarettes. However in addition to verifying these allegations and their continuance through time it is imperative that the resultant adverse effects of e-cigarettes be compared with those of coventional cigarettes. The author’s failed on this mission.
Medical News Today
Electronic cigarettes, seen by many as a healthy alternative to tobacco smoking, do cause damage to the lungs, scientists from the University of Athens, Greece, explained at the European Respiratory Society’s Annual Congress 2012, Vienna, on Sunday. Electronic cigarettes, also called e-cigarettes have also been marketed as effective smoking cessation devices.
Those readers who believe that agency regulatory cycles are determined by election cycles have a point in the short run–but not the long run. Agencies who are funded “off budget” through levies on the regulated industry have life cycles of their own. Consider the following research projects to be undertaken by the FDA. The FDA should advise all recipients of federal funds that the FDA can not use the results of the studies unless they are compliant with the Data Quality Act. CRE has under consideration a program to ensure that the resultant studies are DQA compliant.
Aug. 28, 2012 (Munich, Germany) — Electronic cigarettes do not appear to be bad for your heart, according to the first study to look at the effects of smoking e-cigarettes on heart function.
The devices — battery-powered metal cartridges that simulate the effect of smoking by heating nicotine-containing liquid into vapor — can be helpful to smokers trying to kick the habit, says researcher Konstantinos Farsalinos, MD, of the Onassis Cardiac Surgery Center in Athens, Greece.
Washington (CNN) — A government mandate requiring tobacco companies to place graphic images on their products warning of the dangers of smoking was tossed out Friday by a divided federal appeals court, with the majority saying the requirements were a violation of free speech protections.
The Food and Drug Administration was ordered to immediately revise its rules.
Consumers face a barrage of product claims each day. These claims create consumer expectation of safety and product performance and, assuming they are accurate, facilitate well informed choice. But increased scrutiny of claims, especially where the claim involves potential health outcomes, means that claim substantiation and the science behind it are more important than ever.
The FDA is looking into regulations for premium cigars, which has some members of Congress looking for ways to exclude the tobacco products from agency rules.
WASHINGTON – Premium cigars have had little oversight from the U.S. Food and Drug Administration (FDA), but that is likely to change, Reuters reports.
The FDA has heavily regulated cigarettes and smokeless tobacco since it gained authority over tobacco three years ago, but the agency has largely left cigars alone.
FDA Daily Digest
FDA Center for Tobacco Products Participates in 2012 National Conference on Tobacco or Health
The National Conference on Tobacco or Health (NCTOH) is one of the largest gatherings of the United States tobacco control movement. This year’s theme, “A New Era of Tobacco Control: Policy, Regulation, and Prevention”, will attract a diverse tobacco control audience including more than 2,500 national, state and local tobacco control scientists, program managers, communicators, and advocates, and over 30 public health exhibitors.
The purpose of the conference is to help improve and sustain the effectiveness and reach of tobacco control programs and activities in the United States.
The law firm of Miller and Zois reports:
“In early 2011, the FDA received over 500 reports of Pradaxa bleeding injuries—this within months of the drug’s release. Users of Pradaxa may suffer from internal bleeding, hemorrhaging, or other problems. By December of 2011, the FDA announced a Pradaxa safety review, the first step toward determining whether a Pradaxa recall is necessary.
The National Institutes of Health reports 932 serious events between January 2011 and March 2011:
- 120 deaths
- 25 permanent disabilities because of the drug
- 543 hospitalizations
- 505 incidents of hemorrhage or internal bleeding
Editor’s Note: RIP Harm Reduction. The public policy question is not whether e-cigarettes are “safe” but whether they impart less harm than coventional cigarettes. If we applied the type of thinking set forth in the article below there would be very few prescription drugs on the market.
The jury is still out on safety of e-cigarettes
By Danielle Haynes, danielle.haynes@tonawanda-news.
Tonawanda News — While many electronic cigarettes contain a fraction of the chemicals found in traditional tobacco products, some doctors — and at least one politician — are urging caution until more can be learned about the devices’ health effects and regulations have been implemented.
In a recent Op-Ed for Reuters, FDA Commissioner Margaret Hamburg boasted about the success of the 2009 Family Smoking Prevention and Tobacco Control Act. The news would be quite welcome — if only it were true.
Unfortunately, the effectiveness of the new law’s various measures is nil. Its ban on candy cigarettes and requirement that cigarette makers divulge their ingredients will save exactly zero smokers. And the FDA’s recent attempt to impose large graphic health warning labels on cigarette packages and ads is another empty gesture: Most studies show that such graphic labels have no impact. Dr. Hamburg’s praise for the enforcement actions in the law would be appropriate, except that those rules were enacted first by the Tobacco Master Settlement Agreement in 1999.
The Arkansas Project
just got back from an ALEC conference — a meeting for state legislators and others who are interested in state-level policy ideas that promote free markets, limited government, and federalism. As you may know, ALEC has recently become an object of controversy, largely because some people find the notion of state legislators getting together to discuss conservative ideas frightening and dangerous. Indeed, the attacks on ALEC are typically devoid of analysis; in fact, those attacks are usually composed of (as Lionel Trillingonce wrote in a very different context) “irritable mental gestures which seek to resemble ideas.”
Editor’s Note: The sale of legal cigarettes to minors continues to decline but the sale of contraband cigarettes to minors continues to increase. Federal regulatory agencies continue to devote the entirety of their effort to regulating the sale of legal cigarettes and have walked away from their responsibility to address the contraband issue.
RICHMOND, Va. — Sales of tobacco to minors in the U.S. reached an all-time low in 2011 under a federal and state inspection program intended to curb underage tobacco use, according to a report released Thursday.
Editor’s Note: FDA should take note that, not withstanding the deference generally accorded to federal agencies, courts are willing to enforce agency adherence to legal requirements that regulatory proceedings be balanced. Consequentially, FDA should view the decision to deny the agency’s motion to dismiss the lawsuit as having ramifications that are considerably broader than the TPSAC; the District Court’s precedent effectively upholds and applies to the balance requirements for all agency peer reviewed documents.
By Associated Press
RICHMOND, Va. — A challenge by two of the nation’s largest cigarette makers alleging conflicts of interest in the Food and Drug Administration advisory panel’s review of tobacco products can move forward, a federal judge has ruled.
The Tobacco Control Act gave FDA the authority to regulate the manufacturing, marketing, and distribution of tobacco products, which are responsible for more than 443,000 deaths in the United States each year. FDA now has a powerful new regulatory tool to make tobacco-related disease and death part of America’s past, not its future—and to ensure a healthier life for every family.
In three years, FDA has moved science-based, tobacco-related regulation forward and started a rigorous tobacco research program to enhance the science already available. FDA focuses on three strategic priorities: preventing initiation, particularly among youth; decreasing the harms of tobacco product use; and encouraging cessation.
Dr. Michael Siegel
A WebMD article published yesterday highlights the debate over electronic cigarettes.
On one side of the debate are public health practitioners who argue that there is no evidence that these products are safer than regular cigarettes and that they may be leading to smoking among youth and former smokers.
Editor’s Note: This research is aimed at providing a basis for future regulation
—The US’ National Institutes of Health and the Food and Drug Administration have formed an interagency partnership to foster research relevant to tobacco regulations.
According to an FDA Center for Tobacco Products’ (CTP) press note, this funding opportunity ‘invites center grant (P50) applications for Tobacco Centers of Regulatory Science (TCORS) for research relevant to the Family Smoking Prevention and Tobacco Control Act’.
The press note said that the overall TCORS program objective was to conduct programs of multidisciplinary research that would inform the manufacture, distribution, and marketing of tobacco products related to the regulatory authority of the CTP.
International Tobacco on Line
The U.S. Food and Drug Administration (FDA) on the harm-reduction tobacco products developed by the draft directive, the content and standards are very strict.
Analysts believe that the cigarette manufacturers in accordance with the draft guidance is developed, then it probably never will not enter the market to meet with consumers.
Since then, the U.S. Commission on Science and Health in its daily reports also pointed out that the U.S. Food and Drug Administration believes that the harm-reduction cigarette products and harm reduction.
We read with interest the continuing controversy over FDA’s surveillance of several agency scientists.
The FDA controversy is representative of a government-wide issue regarding the management of scientific conflicts in the US government. Consequently the issue at hand is not an agency specific issue
Does not the USG have the right to monitor emails to safeguard against the release of national security secrets, criminal activities, racial slurs and confidential business information? Why then is there a blanket assumption that the USG government can not monitor the emails of its employees at any level of intensity, however great? Does not the government have the right to monitor to guard against the deaths related to Wiki Leaks?
American Council on Science and Health
In an op-ed for Reuters, Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, boasts about the success of the Family Smoking Prevention and Tobacco Control Act. The news would be quite welcome — if only it were true.
The bill, signed into law by President Obama three years ago, was supposed to reduce the devastating toll of cigarette smoking. As Dr. Hamburg puts it: “The FDA pulled candy and certain other flavored cigarettes off the market; issued new regulations to halt sales of cigarettes, cigarette tobacco, and smokeless tobacco to young people; banned brand-name sponsorship of sporting events and concerts; and implemented requirements for new warning labels for smokeless tobacco products.”
(Any opinions expressed are the author’s own)
By Margaret Hamburg
WASHINGTON (Reuters) – Three years ago, President Obama signed the Family Smoking Prevention and Tobacco Control Act into law. Those of us present knew we were witnessing history. With the stroke of a pen and strong bipartisan support from Congress, the Food and Drug Administration was charged with protecting public health from tobacco use – the nation’s single most preventable cause of disease, disability and death. More than 1,200 people die each day in the United States because of cigarette use. That is one person every 71 seconds. Today, I am pleased to report that the law is working.
new-press. comm (Gannett)
Mike Mangione of Fort Myers can name more reasons than he has non-nicotine-stained fingers for switching from regular cigarettes to an electronic alternative.
He is among an estimated 2.5 million people now inhaling nicotine through a battery-operated device that heats liquid to make vapor, which takes the fire — and the tar and many other cancer-causing chemicals found in cigarettes — out of smoking.
John Celock Huffington Post
Kansas lawmakers are considering a resolution that would require state health officials to conduct a study about the health effects of smokeless tobacco, potentially allowing the state to market smokeless tobacco as a healthier alternative to cigarette smoking.
The Federal and State Affairs Committee of Kansas’ House of Representatives has been debating a measure that would require the state’s Department of Health and Environment to conduct a study of the health effects of using smokeless tobacco — commonly known as chewing tobacco — to determine if it is safer than cigarette smoking.
David Caruson AP
NEW YORK — The City of New York filed a lawsuit Wednesday against a cigarette dealer on an Indian reservation in western New York, claiming that the business has been flouting state and federal law by shipping thousands of packs into the city without paying state or local taxes or verifying the age of the buyer.
The suit, filed in a federal court in Manhattan, targets Robert and Marcia Gordon, members of the Seneca tribe who were outspoken opponents of attempts by state and federal authorities to rein in the sale of untaxed cigarettes from reservations.
WASHINGTON — This month marks the third anniversary of the passage and implementation of the Family Smoking Prevention and Tobacco Control Act, the federal law that authorized the FDA to regulate cigarettes, roll-your-own and smokeless tobacco products.
Over the past three years, some of the major tobacco regulations have included the banning of the sale of cigarettes with a characterizing flavor, the prohibition of self-service displays in retail stores (except in age-restricted tobacco shops), restrictions on advertising claims and the release of nine text and graphic picture cigarette health warnings. The cigarette health warnings are now the subject of two federal lawsuits resulting in a delay of the original effective date of Sept. 22, 2012.
Smoke rises from a cigarette in Sacramento, Calif., Friday, June 22, 2012. Proposition 29, the California initiative to increase the tax on tobacco to pay for cancer research was snuffed out by voters as it failed 49.7 percent to 50.3 precent after remaining to close to call for more than two weeks. (AP Photo/Rich Pedroncelli) Photo: Rich Pedroncelli, Associated Press / SF
AWMA President & CEO Scott Ramminger Wednesday urged the Food and Drug Administration (FDA) to refrain from issuing additional onerous reporting requirements on distributors when finalizing rules on non-face-to-face sales and distribution of tobacco products.
(In the photo, Ramminger and Anne Holloway, AWMA vice president of government affairs, pause before meeting with FDA officials.)
Ramminger, addressing representatives of FDA’s Center for Tobacco Products, explained the role of convenience distributors in the sale of tobacco products and stressed AWMA’s role in enactment of the Prevent All Cigarette Trafficking Act (PACT Act), which is now helping to reduce remote sales, particularly internet sales, of cigarettes for the purpose of evading appropriate taxes.
Another article completely silent on the adverse health effects of counterfeit cigarettes: “Menthol Cigarettes Ban”
Editor’s Note: The following article is representative of the tobacco stakeholder community’s failure to recognize the adverse health effects of counterfeit cigarettes; an event which which will occur with mathematical certainty and one which has never been challenged by any federal agency.
Why then do TPSAC and a number of academic researchers and analysts refuse to study the adverse health effects of counterfeit cigarettes as dcoumented in several CRE studies? One can only speculate but it appears that a number of researchers are more interested in preserving their financial grants than they are in telling their paymasters the straight facts.
A study published this week in the American Journal of Preventative Medicine suggests that graphic cigarette warning labels are more memorable than the standard text warnings that currently appear on the side of every cigarette pack.
Beginning this fall, the Food and Drug Administration (FDA) wants to slap one of the grotesque labels on every pack of cigarettes. The tobacco industry’s legal challenge may prevent the new policy from taking effect, but the researchers and media are claiming the study as evidence that the graphic warnings will reduce smoking. There’s no doubt that a picture of a man smoking through a hole in his neck is more memorable than a text warning about the dangers of tobacco, but there isn’t a bit of evidence that the shocking images will do anything to reduce cigarette consumption.
Where there’s smoke there’s ire, at least when it comes to critics of the tobacco industry on native reserves, evidenced in Ojibway filmmaker Jeff Dorn’s Smoke Traders.
Dorn, who works at CTV Ottawa, spent three years filming in the Mohawk communities of Akwesasne and Kahnawake, documenting a thriving economy both among cigarette runners and the growing number of native-run cigarette factories and tobacco companies.
Announcement From Commissioner Hamburg Announcing Selection of the Deputy Director for the Center for Tobacco Products, FDA
It is with great pleasure that I announce the selection of Richard J. Turman as the Center for Tobacco Products’ (CTP’s) Deputy Director. In this important senior leadership position, Mr. Turman will be responsible for assuring that CTP accomplishes its public health goals and objectives, including implementation of the Family Smoking Prevention and Tobacco Control Act. This will involve assuring effective communications across the Food and Drug Administration (FDA) and CTP, within the Department of Health and Human Services (HHS), and among stakeholders on matters related to tobacco product regulation and CTP’s regulatory authorities.
Editor’s Note: The following article is from the CRE website titled: FACA Under Fire. CRE is submitting comments requesting that the DOJ Science Advisory Board request that federal agencies examine the adverse health effects of counterfeit cigarettes as referenced in several CRE reports.
DOJ Science Advisory Board Meets
Los Angeles Times
Two bills in Congress would remove its authority to regulate cigars. That would be a mistake
The following is the comment letter CASAA has submitted to the FDA. CASAA encourages members to submit their own comments by the end of the day (6/4/12) at http://www.regulations.gov/?
Under the FDA’s Draft Guidance for MRTP Applications, it would cost any smokeless tobacco manufacturer (and any e-cigarette manufacturer if the agency “deems” they should be regulated by Chapter IX, as the FDA has stated it intends to do) tens of millions of dollars conducting unnecessary research before applying to the FDA to truthfully claim that any of its smokefree tobacco products is less hazardous than cigarettes.
Two top American business groups echoed apprehensions by some Filipino legislators that the Malacañang-backed sin-tax reform bill would abet smuggling, undermine the government’s revenue growth targets and subsequently pose serious threats to national security.
The US Chamber of Commerce and the US-Asean Business Council have asked Speaker Feliciano Belmonte Jr. to consider the supposedly counterproductive and deleterious impact of House Bill (HB) 5727 that seeks to impose 1,000-percent to 1,500-percent tax increase on alcohol and tobacco products.
The bill’s principal author, Liberal Party Rep. Joseph Emilio Abaya of Cavite, earlier said that smuggling would be an inevitable aftermath if the proposed law is enacted.
The Indian Express
The campaign against smoking at public places and sale of gutkha packets within 100 metres of educational institutions seems to have lost steam in the city with the Food and Drug Administration (FDA) unable to strictly implement Sections 4 and 6 of the Control of Tobacco Products Act (COTPA). After an impressive show in 2010-11, as seen from the fines collected from violators, 2011-12 saw a dip in number of people being fined. Food and Drug Administration officials admit that the focus on regularisation of licenses of food vendors under the Food and Safety Standards Act was partly responsible for the decline in 2011-12.
Deadline News UK
NHS Fife has prohibited the use of the battery-operated devices in all their premises.
The devices work by heating nicotine capsules to give smokers their fix without the harmful chemicals.
But health bosses say the gadgets are a potential fire hazard, claiming that the heating element that it contains could set bedding alight and that the vapour may set off smoke alarms.
Other NHS trusts are considering implementing similar bans, with NHS Tayside expected to be the next trust to do so.
Cal State Fullerton Bans Smoking, Smokeless Tobacco Use, Alcohol Use, Binge Drinking, Unprotected Sex, and Junk Food Consumption on Campus; Actually, Just Smoking and Smokeless Tobacco Use
Professor Siegel: Rest of the Story
In an act of selective paternalism, the California State University at Fullerton has banned all tobacco use on campus, including smoking in cars and all smokeless tobacco use. The reason for the ban? According to the president of the Academic Senate: “Shouldn’t the university be about health?”
I call this selective paternalism because while the policy bans some unhealthy personal behaviors – smoking and smokeless tobacco use – it does not prohibit others, such as alcohol use, binge drinking, unsafe sex, and excessive junk food consumption.
Editor’s Note: The accuracy of the following statement will be determined in large part by whether FDA’s Harm Reduction is confined to cessation or if, as stautorily required, allows for a decrease in the exposure to toxicants.
“One respondent went so far as to describe e-cigarettes as an “extreme liability risk,” noting the lack of regulation in both the United States and in China, where most of the products are manufactured.”
By JANICE PODSADA, firstname.lastname@example.orgThe Hartford Courant
Tobacco manufacturers that re-label roll-your-own cigarette tobacco as pipe tobacco are cheating federal and state authorities out of an estimated $1.3 billion in lost state and federal tax revenues, according to a report released Wednesday by the Centers for Disease Control and Prevention.
Last month, the Government Accountability Office found that cases of roll-your-own tobacco were being sold in packages labeled as pipe tobacco. The federal excise tax on loose tobacco used for roll-your-own cigarettes is $22 per pound higher than the excise tax on pipe tobacco.
FDA Warns Smokers Against Using Electronic Cigarettes Because Unlike Tobacco Cigarettes, Their Risks are Not Precisely Known
Editor’s Note: We have had our doubts whether FDA’s harm reduction progam was in fact a cessation only program. FDA actions suggest our concerns were well founded.
Rest of the Story- Professor Siegel
Electronic cigarettes, or e-cigarettes, do not contain tobacco, tar, or any of the harmful chemicals packed into traditional cigarettes. But these modern-day nicotine delivery devices may soon be outlawed in certain parts of Cohasset.
The town’s board of health will ask town meeting voters on May 12 to amend the community’s smoking bylaws to ban the use of e-cigarettes in all locations where traditional cigarettes are not allowed. This includes business offices, restaurants, athletic fields, bars, train stations and other spaces where crowds typically gather.
A response to the recent misleading “Deadly Alliance” report implicating convenience stores.
By Seth A. Mailhot, Special Counsel, Sheppard Mullin Richter & Hampton LLP.
This is the first of what will be a continuing series on the regulation of tobacco retailing. In future articles, I will address the U.S. Food and Drug Administration’s (FDA’s) regulation of tobacco retailers, and the pressing issues with FDA enforcement at the retail level. For my inaugural article, however, I address the recently released report “Deadly Alliance: How Big Tobacco and Convenience Stores Partner to Market Tobacco Products and Fight Life-Saving Policies.”
I recently testified before theKansaslegislature in support of a resolution asking the state health department to review the scientific evidence for tobacco harm reduction and its potential benefits for smokers. An American Cancer Society spokesperson opposed the resolution, saying that because the U.S. Food and Drug Administration (FDA) regulates tobacco, it is unnecessary and a waste of resources for any other agency to review tobacco harm reduction.
The FDA was authorized to regulate tobacco in 2009. In March of this year, the agency released a 50-page draft document advising what information will be required for a product to be accepted by the agency as “modified [i.e. reduced] risk” (available here).
Marla Scarola –Weinberg Group
In March 2011, the Tobacco Products Scientific Advisory Committee released a report on the impact of menthol on public health. Based on the committee’s review of all available evidence, they recommended the ban of menthol. Following the release of TPSAC’s report, the FDA began a thorough review of their findings and also considered a report on the issue prepared by the tobacco industry. Stakeholders continue to await the FDA’s final determination and it is unclear when this information will be available.
WASHINGTON — Americans’ smoking habits experienced “sizable market shifts” since federal tobacco taxes were increased in 2009, a new government report concludes.
Sales of pipe tobacco and large cigars, which are taxed at a lower rate, have skyrocketed as smokers have adjusted their buying habits to the new price structure.
Pipe tobacco is increasingly used to make relatively inexpensive cartons of roll-your-own cigarettes. The Fox Valley has several shops with roll-your-own machines available for customers.
Kim Schafer of Appleton Souvenir and Cigar Co. said she’s noticed changing trends in tobacco use.
WASHINGTON — U.S. Senators Dick Durbin (D-Ill.) and Frank R. Lautenberg (D-N.J.) said that the Senate Appropriations Committee, of which they are members, approved report language that would urge the Food & Drug Administration (FDA) to issue regulations asserting its regulatory authority over tobacco products–including cigars–as part of the 2013 appropriations bill for Agriculture, Rural Development, FDA & Related Agencies. The measure now moves to the full Senate for its consideration.
In 2009, President Obama signed the Family Smoking Prevention & Tobacco Control Act, which expanded the authority of the FDA to regulate all tobacco products. The law banned flavored cigarettes, but not flavored cigars.
Analyst breaks news, breaks down Lorillard’s blu ecigs buy
LAS VEGAS — Bonnie Herzog, senior analyst and managing director of tobacco, beverage and consumer research at Wells Fargo Securities LLC, had more than just industry insight to share with those in attendance of her “U.S. Tobacco Trends & Insights” talk Wednesday at the NATO Show in Las Vegas–for many in the audience, she had breaking news. “There was an announcement this morning: Lorillard has bought blu ecigs for $135 million,” Herzog said, who had only just heard the news herself (see full story in this issue of CSP Daily News).
Editor’s Note: It is only appropriate that CRE restate its concern that the FDA in its entirety should be concerned about the safety of imported products and continues to challenge the failure of the FDA to addess the adverse health effects of counterfeit tobacco products.
New report presents FDA’s focus on global cooperation for product safety
The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report1,” detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.
Progress comes one small step at a time. Numerous researchers, including those as at the Centers for Disease Control and Prevention (CDC), have warned that counterfeit cigarettes contain far higher leads of lead, cadmium and other metals compared with legally produced products.
To study the health effects of contraband, researchers need to conduct two types of studies:
- Research on the levels of toxic metals in counterfeit cigarettes compared with genuine brand products; and
- Research on elevated health consequences of consuming counterfeit products.
Written by Frederic J. Frommer Associated Press
Companies argue against corrective advertising mandate
WASHINGTON — A bid by tobacco companies to overrule a court judgment that they must do corrective advertising about the dangers of smoking received a chilly response from a federal appeals court Friday.
The companies want U.S. District Judge Gladys Kessler’s order overturned because a 2009 law gave the Food and Drug Administration authority over the industry, including power to require graphic cigarette warnings. In 2006, Kessler ruled that America’s largest cigarette makers concealed the dangers of smoking for decades, in a civil case the government had brought under the Racketeer Influenced and Corrupt Organizations, or RICO, law.
|By Laura Walter|
|Penton Business Media|
James P. Moriarty, MSc, and colleagues of theMayo ClinicinRochester, Minn., analyzed the incremental costs of smoking and obesity amongMayo Clinicemployees and retirees who had continuous health insurance coverage between 2001 and 2007. They found that both obesity and smoking were associated with excess health care costs.
Smokers, for example, carried average health costs that were $1,275higher than those for non-smokers. But the incremental costs associated with obesity were even higher: $1,850more than for normal-weight individuals. For those with morbid obesity, the excess costs added up to $5,500per year. (According to the Mayo Clinic, individuals with a body mass index, or BMI, of 30 or higher are obese; those with a BMI of 40 and higher suffer from extreme, or morbid, obesity.)
Editor’s Note: Unilateral actions by one state is another step in ensuring the sale of contraband products whose toxicty has been demonstrated to exceed allowable norms. The State of Virgina recognized the harmful effects of contraband cigarettes and took the responsible approach passing legislation to address the public health implications to prevent – not accelerate- contraband cigarette trade. See the attachment below.
By WKBW News
According to a news release:
National Public Radio
by Alva Noë
Can the federal government require tobacco companies to put scary pictures on cigarette packs? At least one federal district judge has said “no.” You can regulate commercial speech to protect consumers. This means you can punish tobacco companies for making false claims, denying the health risks associated with smoking. And you can even require cigarette packaging to contain labels disclosing those risks. But you can’t compel makers of cigarettes to participate in a campaign against smoking. That crosses the line, wrote Judge Richard Leon.
U.S. Food and Drug Administration
Everyone knows that smoking is bad for you, but the government has decided the situation is so dire that consumers who want to light up need to be greeted with a dead man on an autopsy table.
A federal appeals court heard arguments on Tuesday and is considering the constitutionality of the government’s requirement that cigarette packs carry graphic warning labels, which include diseased lungs and gums and a cadaver on an autopsy table.
Talkine Host Hoppy Kercheval
West Virginai Metro News
Smoking is bad for you. It causes a litany of health problems, including cancer, lung and heart disease. Pregnant women who smoke can harm their unborn child. Smoking is addictive.
We know these things because we have been told over and over. Anti-smoking groups run campaigns to discourage kids from starting to smoke and to try to get people to stop. Cigarette companies must include health warnings on each pack.
But should cigarette makers be forced to do even more to prevent people from buying their product?
Two weeks after fighting for the survival of its signature healthcare reform law before the Supreme Court, the Obama administration will be back in court Tuesday to defend another part of the president’s agenda to make Americans healthier.
The D.C. Court of Appeals is scheduled to hear oral arguments in a case brought by five tobacco companies challenging regulations requiring graphic warning labels on cigarette packs and advertisements starting in September. Once again, the administration is finding itself accused of overstepping its constitutional authority, this time on First Amendment grounds.
Sheppard Mullin Richter & Hampton LLP on 4/4/2012
author: Seth A. Mailhot]
As part of Sheppard Mullin’s monthly blog on tobacco retailer issues, we are taking a look at the possible future of retailer-operated rolling machines. On March 8, 2012, the U.S. Senate adopted an amendment to the federal highway bill “Moving Ahead for Progress in the 21st Century Act” (MAP–21) that included a provision impacting retail establishments that offer rolling machines for use to customers. The provision would have changed the definition of “manufacturer of tobacco products” in section 5702(d) of the Internal Revenue Code of 1986 to “include any person who for commercial purposes makes available for consumer use . . . a machine capable of making cigarettes, cigars, or other tobacco products.”
A new report on the crime effects of smoking demonstrates that there would be an increase in counterfeit cigarettes, smuggling, and hard-line new rules could be counter-productive, argues Milan-based professor Ernesto Savona.
Savona is professor of criminology at the Università Cattolica del Sacro Cuore in Milan and the director of Transcrime, a joint research centre with the Università degli Studi di Trento. He spoke from Milan to EurActiv’s Jeremy Fleming.
In your work as a criminologist, have you conducted these criminal proofings of policy proposals before, and if so what types?
The U.S. Food and Drug Administration (FDA) released two separate draft guidance documents to help fight the tobacco epidemic and stop children from using tobacco. The draft guidance documents implement provisions of the Family Smoking Prevention and Tobacco Control Act that will ultimately provide the public with previously unknown information about the chemicals in tobacco products and help prevent misleading marketing about the risks associated with tobacco products.
The first document provides guidance on how companies will comply with the requirement to report on the quantities of potentially harmful chemicals in tobacco products. The second document provides guidance to companies that seek to advertise or market a tobacco product as less harmful or associated with reducing the risk of tobacco-related disease.
Editor’s Note: The following commentary by Geoffrey C. Kabat, Ph.D., a cancer epidemiologist at the at the Albert Einstein College of Medicine, concludes that “our study indicates that smoking mentholated cigarettes does not appear to influence risk over and above the effect of smoking per se.”
By Geoffrey C. Kabat
The U.S. Food and Drug Administration (FDA) is currently considering whether to ban the use of menthol as an additive to cigarettes. Mentholated cigarettes account for roughly 30 percent of cigarettes sold in the United States, and they are favored by African-American smokers by roughly a threefold margin compared to white smokers. They are also favored by women smokers. A major aspect of the FDA charge is to determine whether use of mentholated cigarettes is more harmful than use of non-mentholated cigarettes.
GREENSBORO — Todd Ridge stopped smoking Camel Lights last year after taxes pushed the price to $4.60 a pack. Now he makes his own cigarettes at the Liberty Tobacco store in Archdale, cutting his habit’s cost in half.
Over the past 4-1/2 years, mom-and-pop stores have installed more than 1,900 roll-your-own cigarette machines in 42 states, according to RYO Machines, which makes them. Taking advantage of a loophole in federal tax laws, some retailers are selling tobacco labeled as the pipe variety, which is taxed less, even though it often winds up in cigarettes.
THE NEWS: A Food and Drug Administration scientific advisory panel says dissolvable tobacco products could reduce health risks compared with smoking cigarettes but also have the potential to increase the overall number of tobacco users.
THE DRAWBACK: Despite its findings after months of public meetings and presentations, the panel noted that there’s a lack of research on the products that account for a small share of the market.
Following a federal court decision that graphic warning labels were unconstitutional, an appellate court has ruled that requiring cigarette warning labels are not a violation of free speech, rather they fall under commercial speech disclosures, are disclosing the health risks of cigarettes and are reasonably related to the government’s interest of preventing the deception of consumers.
The U.S. Court of Appeals for the Sixth Circuit issued a ruling on the appeal of a 2009 lawsuit challenging numerous FDA tobacco regulations, the National Association of Tobacco Outlets (NATO) reported.
Editor’s Note: CRE is generally in sync with a number of statements made on CSPNet.Com—a website sponsored by the retailing industry. Regarding the menthol proceeding, CSPNet.com states: “the extensive delay has become the butt of jokes and doubts about the FDA’s ability to truly oversee the complex tobacco industry.”
We fail to understand why it is a joke when a federal agency works in a diligent manner to base its analyses and decisions on sound science and therefore not act in an arbitrary fashion to address an alleged delay which is not at all that extensive given the complexity and myriad of issues the FDA is addressing.
Another day, another series of legal challenges for the tobacco companies. Is their any industry other than the tobacco industry where the legal and regulatory environment has been more treacherous over the last several decades? While the big three, Altria (MO), Reynolds (RAI), Lorillard (LO), faced their biggest legal challenges in the 1990s, the onslaught of constant civil litigation against these companies has continued. While the S&P 500 (SPY) has outperfomred most tobacco and other consumer staple names this year, most major U.S. tobacco companies have outperformed major index funds by a large margin over the last several decades.
Five U.S. senators (all Democrats) sent a letter to the U.S. Justice Department and the Food and Drug Administration (FDA) this week in a call to action. Legislators say a “misguided ruling” from a U.S. District Court “threatens to undermine efforts to prevent the deadly impacts of smoking.”
EDITORIAL | TOM KEANE
March 10, 2012|By Tom Keane
FREE SPEECH has been in the news lately. In the wake of Rush Limbaugh calling a Georgetown law student a “slut,’’ the ubiquity of vile commentary has caught public attention. CNN contributor Roland Martin tweeting an anti-gay comment and liberal talk show host Bill Maher calling Sarah Palin a “dumb [expletive]’’ are just two more examples of a coarsening of political discourse that treats the ad hominem as argument and polarizes rather than illuminates.
FDA Appealing Cigarette Warning Label DecisionChallenging ruling tossing out graphic image requirement as violation of free speech
WASHINGTON — The U.S. government has appealed a federal judge’s ruling throwing out requirements for graphic warning labels regarding the health risks of cigarettes, said a Bloomberg report.
The U.S. Food & Drug Administration (FDA) has filed a notice of appeal in U.S. District Court in Washington seeking to overturn Judge Richard Leon’s February 29 decision that the government’s rule violates the tobacco companies’ rights to free speech.
Last summer, the Tobacco Products Scientific Advisory Committee (TPSAC) released a report that was supposed to help guide the FDA in deciding whether to ban menthol cigarettes from the market. Instead of issuing a specific recommendation, however, the TPSAC report merely suggested that the agency should consider all of the potential effects of a menthol ban if it does consider such a policy. Unlike TPSAC, however, ACSH’s Dr. Gilbert Ross has a strong opinion on the potential menthol proscription: He thinks it’s a bad idea. “The rationale for such a ban is flawed, and the repercussions will be dangerous for public health,” he says.
March 2 (Bloomberg) — The Obama administration’s delay of costly regulations, including one to require rearview cameras on cars and light trucks, weakens a Republican line of attack ahead of the election.
President Barack Obama has been hammered by Republicans for promulgating expensive rules, and the party’s front-runner for the presidential nomination, Mitt Romney, vows to do away with “job-killing regulation.” The camera requirement, mandated by a 2008 law signed by Republican President George W. Bush, was listed by the Obama administration last year as one of the five most expensive pending regulations, with an estimated price tag of as much as $2.7 billion.
Editor’s Note: FDA has lost the single most high profile issue on the maiden voyage of the Center for Tobacco Products. CTP is need of a serious post mortem to ensure that the agency has in place procedures that result in regulations that are not only supported by prevailing law but are science based. To this end CTP should invite public suggestions on how its evalution procedures could be improved while the agency is in its infancy.
Bloomberg NewsThe U.S. Food and Drug Administration was blocked Wednesday by a federal judge from requiring tobacco companies to put graphic health warnings on cigarette packaging.
Yesterday CTP held a meeting, chaired by Dr. Ashley, aimed at describing its research program. The agency described in considerable detail the wide range of research programs it was undertaking.
The program was highly interactive in that it was not the normal drab program of technical wonks speaking in a monotone to a dazed audience. Instead each panel was followed by a lively discussion of relevant issues.
CTP made it clear that the purpose of the meeting was not only to educate the audience of what it was doing but that CTP was interested in the scientific undertakings of those attending the meeting.
Coakely Health Report
February 22, 2012 – UK quit smoking campaigns come under fire February 22, 2012 – 10:07 am, by Melissa Sweet Quit smoking campaigns in the UK that promote nicotine replacement therapies (NRT) are wrong to discourage the “cold turkey” approach, and could learn a lesson from Australian efforts, suggests Simon Chapman, professor of public health at the University of Sydney. ***
Paul A. Achoa
Recently, the Food and Drug Administration conducted an electronic cigarette review to test the safety of these popular electrical devices. According to the agency, the results of its examination revealed some troubling issues; and it has issued a report warning consumers about the potential health risks associated with the products.
What is an e-cigarette?
E-cigarettes are battery-powered devices designed to provide users with nicotine and flavor by converting the drug into an inhalable vapor. Most of these devices are designed to resemble traditional cigarettes; however, some may look like other products, such as USB memory devices or pens.
Since June, New York has seized more than 5 million cigarettes produced by Native American companies
ALBANY, NY – New York has seized more than 5 million cigarettes produced by Native American companies since June for failure to pay state excise taxes, the Buffalo News reports.
State officials said the seizures represent roughly $1.5 million in taxes that its sellers were intending to avoid.
Last summer and pursuant to a court ruling, New York began enforcing a state law prohibiting wholesalers from selling untaxed cigarettes to Indian retailers for sale to non-Indians.
Convenience Store Decisions
By Lou Maiellano.
Imagine, if you will, that European explorers land in Africa, North America or South America in the 14th, 15th or 16th centuries. Upon landing, these explorers find the inhabitants of these exotic new lands drinking a strange, energizing brew and smoking the dried beans of a native tree in hand carved pipes.
But in this case, the brew is from tobacco and the smoke is from the coffee bean. The beverage delivers the energizing effects of nicotine and the pipe delivers the stimulation of caffeine in its rich, aromatic smoke. Given that set of facts in this brief, retelling of the history of the new world, how would today’s world be different? I think we know.
Editor’s Note: Attached below is a study from the Adam Smith Institute, Plain Packaging: Commercial expression, anti-smoking extremism and the risks of hyper-regulation. Key points emphasized in the study include:
1. “One in nine cigarettes smoked around the world is counterfeit or smuggled. The illicit market lowers prices, fuels underage consumption, deprives the treasury of tax revenue and makes an unhealthy habit still more hazardous.”
2. “190 billion counterfeit cigarettes are made each year in China alone and 65% of the cigarettes seized in the EU are counterfeit.”
CBS/AP) So much for being safer. An electronic cigarette blew up in a Florida man’s face, leaving him in a hospital with severe burns, missing his front teeth and a chunk of his tongue.
Fire officials said Wednesday that the man had switched to electronic cigarettes to try and quit smoking, and that the scary situation was caused by a faulty battery.
“The best analogy is like it was trying to hold a bottle rocket in your mouth when it went off,” said Joseph Parker, division chief for the North Bay Fire Department. “The battery flew out of the tube and set the closet on fire.”
The Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) has posted a draft summary of their report on dissolvable tobacco products. The report is available for download here. The report was required by Congress and will be considered by the FDA is it evaluates how to regulate newer dissolvable tobacco products.
I attended portions of the meetings held in preparation for this report, and offered my comments as part of the open hearing. A video of my testimony is available here. I am disappointed with TPSAC’s approach so far.
Editor’s Note: Sorry we are old school. We see no compelling reason for federal employees to turn to the Congress as the first institution for redress as opposed to the last institution. There are a number of channels the employees could have used to address their concerns prior to turning to the Congress. The federal managers who took actions to correct the actions of the disgruntled scientists should be promoted.
Official says agency perused private email accounts of workers while investigating leaks of confidential information
The Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) has posted a draft summary of their report on dissolvable tobacco products. The report is available for download here. The report was required by Congress and will be considered by the FDA is it evaluates how to regulate newer dissolvable tobacco products.
I attended portions of the meetings held in preparation for this report, and offered my comments as part of the open hearing. A video of my testimony is available here. I am disappointed with TPSAC’s approach so far.
Counterfeit cigarettes being sold in Sussex contain abnormally high levels of cancer-causing chemicals, a BBC investigation has revealed.
BBC South East Today found some brands had eight times as much lead as normal cigarettes.
Hastings MP Amber Rudd said many people were not aware of the dangers posed by brands smuggled into the country.
A pro-smoking lobby group said the high level of taxation on legal cigarettes was driving the illegal trade
The tests follow a BBC investigation in October into the illegal cigarette trade in Hastings and St Leonards.
CSP Daily News
ROCKVILLE, Md. — As the tobacco industry awaits a decision on menthol from the FDA’s Center for Tobacco Products (CTP), Dr. Lawrence Deyton, CTP director, took time to provide information to CSP Daily News/Tobacco E-News about where the process currently stands.
Deyton explained that the menthol report provided to the CTP by the Tobacco Products Scientific Advisory Committee was a requirement of the Tobacco Control Act and “just that, advisory.” That report, released in March 2011, concluded that the “removal of menthol cigarettes from the marketplace would benefit public health in the United States.”
Editor’s Note: CRE has a different view from FDA with respect to the applicability of the DQA peer review guidelines to this proceeding. CRE is of the view that the intent of the guidelines was to allow the public to interact with the peer reviewers while the peer review is underway. FDA has rejected the CRE call for transparency and public participation.
Update on FDA’s Review of the Science
The Iowa Alcoholic Beverages Division has won a three-year contract to help the F.D.A.’s effort to cut smoking among minors. I.A.B.D. spokesperson, Tonya Dusold, says the program will make sure retailers are complying with marketing and sales laws regarding tobacco.
She says the certified investigators will go out and do tobacco checks on retailers and then send that information for enforcement and penalties to the F.D.A. Dusold says it’s part of a nationwide effort to curb underage smoking.
Source: NPR.org, INFORUM
The Food and Drug Administration has gathered a group of scientists and other experts to study flavored melt-in-your-mouth tobacco products.
The panel, meeting this week, will hear from two camps of stop-smoking advocates: those who worry that dissolvables are a gateway to smoking and others who say they help people kick the habit.
The government regulates dissolvables like other smokeless products such as chew and snuff and the warning labels are similar.
Companies can’t market dissolvables as a stop-smoking aid. Some health officials and a group of U.S. senators have called them “nicotine candy” and want the FDA to tighten the rules.
The Associated Press
Ohio’s top prison official has asked his department to investigate whether an increase in violence is linked to a tobacco ban and the subsequent use of contraband tobacco as a commodity among inmates.
“Tobacco has become a currency that’s used in our prisons,” with a hand-rolled cigarette valued at up to $5, Ohio Department of Rehabilitation and Correction Director Gary Mohr told the Dayton Daily News .
As required under the provisions of the Family Smoking Prevention and Tobacco Control Act (the law which granted the FDA the authority to regulate cigarettes, roll-your-own tobacco and smokeless tobacco), the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) studied the use of menthol in cigarettes and issued a report and set of recommendations on March 18, 2011.
The TPSAC report contained numerous conclusions, and several of the most significant conclusions are as follows:
(1) The evidence does not indicate increased disease risks in smokers of menthol cigarettes compared to non-menthol cigarettes.
By Pamela McGowan Health reporter
Published at 12:01, Tuesday, 17 January 2012
A major clampdown on illicit tobacco has made a dent in sales across Cumbria, a new survey has shown.
Since 2009 a campaign has been underway to encourage organisations to tackle sales of illegal cigarettes and tobacco. Since then, the total volume being bought has dropped by 11 per cent across the north west, including Cumbria.
This equates to nearly 60 million fewer illegal cigarettes – and over £13m less in duty and VAT evasion as a result.
The Ariva tablet is “the future of tobacco,” according to its maker. A proposal in Linn County to regulate the sale of the dissolvable product may be the future of public-health efforts to restrict access to nicotine.
“These products are popping up more and more,” said Jill Roeder, Linn County Public Health healthy behaviors branch manager. “This is just to set the stage so when they come our kids can’t buy them.”
At least one retailer doesn’t care to be caught up by the new rules.
By Nancy Walsh, Staff Writer, MedPage Today
Published: January 10, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Smokers are no more likely to give up cigarettes for good by using nicotine replacement products such as patches and gum than if they did not use those quit-smoking aids, a prospective cohort study showed.
by Sam Adams on December 31, 2011
H.R. 1639 / S. 1461 – Traditional Cigar Manufacturing and Small Business Jobs Preservation Act
Did you know that on April 26, 2010, December 20, 2010, and July 7, 2011 the U.S. Food & Drug Administration publicly posted their intent to regulate cigars in the Federal Register?
Some of the measures FDA could consider, as we believe they are, include:
- Ban on walk-in humidors, self serve cigar displays, and mail-order cigar sales;
- Ban on all flavored cigars, that are enjoyed by legal-age adults;
SYRACUSE, N.Y. — Midnight on Dec. 31, 2011 will bring more than a new year. In New York State it will bring tougher tobacco laws.
Beginning with this Sunday, a new law bans the sale of flavored tobacco and water pipes used to smoke it to anyone under 18 years old. But, as WSYR-TV reports, the ban is coming at time when using a hookah pipe is growing in popularity in Central New York.
The law will also require smoke shops to post signs informing customers of the new law.
In “dueling press releases” by Sebelius and FDA Commissioner Margaret Hamburg, the latter cited studies showing Plan B safety below the age of 16, while Sebelius claimed insufficient testing in 11-year-old girls, of whom 10 percent are capable of becoming pregnant.
Jacob Sullum | Reason Magazine
A couple of weeks ago, I noted that if the FDA chooses to regulate cigars it could decide to follow New York City’s asinine example by banning flavored varieties because they supposedly encourage kids to smoke. Last week five senators—Dick Durbin (D-Ill.), Frank Lautenberg (D-N.J.), Sherrod Brown (D-Ohio), Jeff Merkley (D-Ore.), and Richard Blumenthal (D-Conn.)—urged the FDA to do just that:
As teenagers turn to cigars instead of cigarettes, these products pose a serious threat to public health and threaten to undermine the important public health protections of the Family Smoking Prevention and Tobacco Control Act.
FDA may soon propose regulation that could ban many/most e-cigarette products, eliminate many/most companies in Electronic Cigarette News
A note of clarification here: While the FDA has announced their intent to regulate not only e-cigarettes but all tobacco products under the Tobacco Act, this has not yet occurred. The Family Smoking Prevention and Tobacco Control Act (which became Chapter IX of the Food, Drug, and Cosmetics Act) named specific products. NOT named were such products as cigars, hookahs, e-cigarettes. In order to bring these additional products in, the FDA will need to propose the regulations (which they have already announced that they plan to do, but have not done so yet). Then, there will be a period of public comment (Regulations.gov). Finally, the FDA will announce that it has published (or decided to drop) the proposed regulation.
If you have a risk factor for lung cancer, smoking is going to make it worse. Sure, if you have a rick factor you may get lung cancer whether you smoke or not and 90% of smokers will never get lung cancer, but the multi-billion dollar marketing campaign against smoking doesn’t like to engage in science or fact – yet an “e-cigarette” would seem to be a happy medium for everyone, right? They mimic mimic the look, feel and taste of traditional cigarettes, and deliver the dose of nicotine a smoker craves without most of the 10,000 chemicals in cigarettes. That has to be better, for people who just will not quit.
|Editor’s Note: Industry documents have been on public record for months if not years. At no time during the extensive public comment period provided by the FDA did the aformentioned “researchers” surface these argments.–unlike CRE who not only made all their arguments public but allowed the public to comment on them on this Interactive Public Docket. Notwithstanding the constant flow of ‘hail mary” passes against menthol, CRE will read the study and if warrants a review CRE will conduct a detailed review and report the findings herein. Interesting the “researchers” refuse to look at the toxic effects of contraband.|
Swisher Sweets could be the next target of federal tobacco regulation.
A group of U.S. senators is urging the Food and Drug Administration to ban flavored cigars, claiming the “candy-like flavorings” increasingly are luring teens into the smoking habit — even as they turn away from cigarettes.
“Cigars contain the same toxic and cancer-causing chemicals contained in cigarettes, and public health experts have warned that cigars are not safe alternatives to cigarettes,” the senators wrote in a letter to FDA Commissioner Margaret Hamburg.
2011 in Review: Local Tobacco IssuesNATO executive director looks at issues that have affected retailers at the local level this year
In 2011, there has been an increase in local governments considering ordinances to further regulate tobacco products, restrict tobacco advertising and impose new local excise taxes on tobacco products. Aside from budget deficits prompting proposals to raise excise taxes, there are two main reasons why local governments have been pursuing more restrictive laws and higher taxes on tobacco products.
It is easy to see why one-in-five small businesses list regulations as their biggest obstacle; just look at Tampa-based J.C. Newman Cigar Company.
At 116 years old, it is America’s oldest family-owned premium cigar maker. In 1895, J.C. Newman borrowed $50 and started a cigar company. At the time, he was an unemployed cigar maker eager to achieve the American Dream. He did just that, building a small business that withstood 19 recessions, three panics, two depressions, two world wars and the Cuban embargo. Newman Cigar Co. innovated and adapted to a changing world, and today employs 125 people.
The Obama administration on Tuesday appealed a U.S. judge’s ruling and injunction that blocked tobacco companies from having to display graphic images on cigarette packs and advertising, such as a man exhaling smoke through a hole in his throat.
The appeal had been widely expected after U.S. District Judge Richard Leon earlier this month sided with tobacco companies and granted a temporary injunction blocking the requirement.
He said the companies would likely succeed in their lawsuit challenging the new graphic warnings as unconstitutional because it compels speech in violation of the First Amendment.
WINSTOM-SALEM, N.C. — Since starting a second round of testing, R.J. Reynolds Tobacco Co.’s dissolvable tobacco products are proving popular among women.
The product line — Camel Sticks, Camel Strips and Camel Orbs –do not require spitting, which could be a deciding factor among female tobacco users. According to a report in the Winston-Salem Journal, females represented 45 percent of all adult smokers who bought Camel Sticks, Camel Strips and Camel Orbs during September and October. Of all adult tobacco users, 31 percent were women.
By comparison, the news outlet reported that adult males make up 85 percent of moist snuff and Camel Snus users.
Judge rules that New York City flavor ban is allowed under FDA law
NEW YORK — A federal district court judge has issued an order upholding a New York City ordinance that bans the sale of all flavored tobacco products, except cigarettes, that contain a constituent or additive that imparts a characterizing flavor other than the taste or aroma of tobacco, menthol, mint or wintergreen.
NATO Retailers Respond to FDA Form Fourteen submit comments electronically on FDA violation reporting form
Fourteen NATO retail members submitted comments electronically via the federal government’s www.regulations.gov Web site, in response to the FDA’s proposed Tobacco Products Violation Reporting Form.
The FDA is proposing to allow the public and other stakeholder organizations (including anti-tobacco groups) to report possible retail violations of the FDA’s tobacco regulations by using a new Violation Reporting Form. The FDA is planning to allow the reports to be filed over the telephone, over the Internet, through a smart phone application or by mail.
Decisions are expected by end of March
Just over a month ago, the Food and Drug Administration issued two requests for proposals for the government agency’s first tobacco public education campaigns, all of which will target teens.
The FDA was granted the authority to regulate tobacco products by the Family Smoking Prevention and Tobacco Act, signed into law in 2009, and could spend up to $600 million on the combined budgets over the course of five years. The first RFP is aimed at preventing tobacco use among youth, aged 13-17, with a budget ceiling of $390 million.
By Laura Leslie
Politics is my first love, but science is a close second. So it’s a good day for two intersect, as they did today in Research Triangle Park.
Governor Bev Perdue, Senator Richard Burr, and Congressman David Price were on hand for this morning’s ribbon-cutting at Medicago, a Quebec-based vaccine maker that’s figured out how to use tobacco plants to produce flu vaccine – bringing in 85 jobs and $11 million in investment along the way.
We have an FDA who hasn’t done their job in protecting us from listeria from Cantaloupes, Salmonella from lettuce, mercury from fish, poor health conditions in slaughter houses. Yet this same FDA wants to ban Menthol cigarettes in spite of being opposed by almost every police organization in this country. How will we enforce it? Will police stop and taste people’s cigarettes? What will happen is the companies will manufacture overseas, (more loss of jobs), and create a whole new group of violent smugglers. We have put a notice on cigarettes that they are harmful to health and limited the advertising, (you can lead a horse to water,etc).
By Maggie Fox
A federal judge blocked a U.S. rule requiring tobacco companies to display graphic images on packs of cigarettes on Monday, saying cigarette companies were likely to win their argument that the law violates free speech rights, Reuters reported.
U.S. District Judge Richard Leon sided with tobacco companies in their fight against the U.S. Food and Drug Administration’s requirement that cigarette packs carry the images, which include pictures of diseased mouths and a person smoking through a tracheostomy tube in the neck.
In the previous post we alerted our readers to the fact that as a result of the Center for Tobacco Products overwhelming large budget they are able to work simultaneously on many fronts–including the award of hundreds of million dollars in grants which will purchase both technical and political support. We also identified the recently initiated study on the establishment of nicotine standards.
As expected when an agency embarks upon a regulatory pilgrimage studies come out of the woodwork. For years it has been accepted that nicotine per se does not constitute a threat to public health. With the new nicotine standards program ready to take off, one might expect the following research to emerge.
Editors Note: The FDA Center that regulates the tobacco industry is turning out to be the “regulator of all regulators”; not only because it has attracted some of the most talented personnel in the agency but because it is has an independent source of funds—-direct charges to the tobacco industry. Reports are that the budget for the Center will eventually approach 3/4 of a billion dollars per year. Funds of this magnitude will overshadow by far the advocacy efforts of the industry. The recent initiatives announced by the Center regarding the longitudinal study of smokers and its nicotine standards program will be presented in a manner which will challenge the ability of the public and the industry to challenge them because of their breadth, depth, complexity and sheer volume resulting from an overwhelming level of resources which may or may not attain an acceptable level of quality.
New York Times
When a truck recently delivered 45,000 cartons of cigarettes to a research company in North Carolina, it was a turning point in the government’s war on smoking.
These were no ordinary cigarettes, but experimental ones, made of genetically altered tobacco to lower the nicotine content by 97 percent while preserving all the other tastes and smells and rituals for smokers of conventional cigarettes.
Researchers had been seeking a new and bigger supply because shortages had limited previous studies to just dozens of people. The experimental cigarettes are produced by a Massachusetts company, the 22nd Century Group, which holds 98 patents for genetic manipulation of tobacco plants to reduce or increase the amount of nicotine in cigarettes.
As a result, St. Louis Circuit Judge Michael David declared a mistrial in the $700 million lawsuit against the cigarette maker.
“After 11 years of pre-trial proceedings and a month and a half of testimony, today’s mistrial shows that the plaintiffs failed to convince a jury of their claims,” Murray Garnick, Altria Client Services senior vice president and associate general counsel, speaking on behalf of Philip Morris, said in a statement Tuesday.
The House Judiciary Committee held a hearing on October 25th to consider the proposed Regulatory Accountability Act of 2011. The bill would mandate analysis of the costs and benefits of any attempt by FDA to ban menthol cigarettes. The bill would also allow judicial enforcement of the bill’s analytic requirements. Such analysis would shed new light on proposals to outlaw menthol cigarettes. The legislation would mandate the analysis of the key issues CRE has raised to the TPSAC and FDA including:
1. The public health consequences from the sale of counterfeit cigarettes which contain far higher levels of lead, mercury and other toxins than legal products; and
By Kevin Godbee
U.S. Senators Richard Blumenthal (D-Conn.), Frank Lautenberg (D-N.J.), and Sherrod Brown (D-Ohio) have sent a letter dated October 14, 2011, to U.S. Food and Drug Administration Commissioner Margaret Hamburg, requesting that the agency “move swiftly to issue a strong regulation that would legally treat or deem all tobacco products, including cigars, pipe tobacco, and hookah tobacco and accessories, as subject to the Tobacco Control Act.”
The Fraternal Order of Police has sent a letter to the Commissioner of the FDA stating:
“Historically, the FOP has been very engaged in matters of public policy which impact the trafficking in illegal products. As a result, we have endured significant criticism in the past because we questioned the wisdom of government policies which, while designed to combat youth smoking or reduce smoking overall, also greatly contributed to a rise in tobacco smuggling and a huge loss in revenue from taxes on tobacco products.”
HILLSBORO, Ohio (AP) – The Ohio Supreme Court is set to hear arguments Wednesday in a bar owner’s challenge to the state’s ban on smoking in workplaces.
The ban prohibiting smoking in most indoor, public places was overwhelmingly approved by voters in 2006 and took effect in 2007.
The owner of Zeno’s Victorian Village in Columbus challenged the law after the tavern was cited for violations and fined $33,000. It argues the law is unconstitutional.
California, ever the trendsetter, has inspired proposed congressional legislation aimed at cracking down on tobacco smuggling and increasing cigarette tax revenues.
The Smuggled Tobacco Prevention, or STOP, Act would require that tobacco products carry a high-tech stamp, similar to one used in the Golden State, that allows government investigators to track cigarette packages and determine whether taxes were paid and whether tobacco is being diverted to illegal markets.
The measure is modeled after a California program that began in 2005 and has reduced cigarette tax evasion by $133 million annually, according to the State Board of Equalization.
By Rob Taylor
CANBERRA | Wed Oct 12, 2011 6:27am BST
CANBERRA (Reuters) – Australia’s government may have to delay plans for the world’s toughest anti-tobacco laws after conservative opposition lawmakers on Wednesday postponed a final vote on the controversial legislation in parliament.
The new laws, which will force cigarettes to be sold in plain packaging from 2012, are being closely watched by New Zealand, Canada, the European Union and Britain, which are considering similar restrictions.
“More than 100 illegal brands appeared on the market against the 30 detected in 2010,” ACPI spokesman Gerardo Velazquez said.
The number of packs of illegal cigarettes sold last year rose to “40 million, against the 200 million estimated by the end of 2011,” Velazquez said.
By Marti Lotman
The Food and Drug Administration and the National Institutes of Health announced Thursday that they will be working to follow the health and behavior of 40,000 smokers aged 12 and older to study the effects of sweeping 2009 tobacco regulations.
Congress asked the FDA to regulate tobacco products that year and the agency has since overseen the advertisement and product designs of the tobacco industry, including marketing to children.
The new study aims to not only make consumers even more aware of the risks associated with tobacco products, but to help modify regulations.
Electronic cigarettes, more commonly referred to as E cigarette devices, are cigarette alternatives where in instead of burning tobacco, it vaporizes nicotine in small amounts and provides you with the same smoking experience while avoiding all the adverse health risks associated with tobacco smoke inhalation.
One of the more reliable electronic cigarettes have been first made available in 2004 by a Chinese company called Ruyan which is now well-known for manufacturing good quality electric cigarettes.
Editor’s Note: On the first reading of this article in BackStage Magazine we were astounded only to realize that it was in the humor section of the magazine
Illustration by Eric Kohn
WASHINGTON — Regulators for the Food and Drug Administration announced this week that beginning in 2012 cigarette manufacturers will be required by federal law to display a nude photo of actor Marlon Brando on all packages of cigarettes sold in the United States.
Editors Note: In the CRE testimony to TPSAC on Modified Risk Products, CRE stated that:
“the marketing of modifiable risk tobacco products will be permitted when it is reasonably clear that:
1. The new product will not be more harmful than existing products; and
2. There is a reasonable scientific basis indicating the new product has the potential to reduce the risk of adverse health effects from consumption of tobacco products.”
Complete testimony at http://www.thecre.com/tpsac/?p=1652
Some health experts are now stating that dissolvable tobacco products are targeted towards youth notwithstanding the following statement which is buried in the article.
Editor’s Note: We can not identify the date of the following post; however its substance supports the conclusion that contraband is a significant issue.
September 27, 2011 — A federal judge expressed doubts during a hearing last week about whether the U.S. Food and Drug Administration (FDA) can force tobacco companies to post graphic images on their cigarette packages showing the negative effects of smoking, according to a Washington Post report.
In June, the FDA announced that it will require larger, more prominent health warnings on all cigarette packaging and advertisements in the U.S., beginning in September 2012. (Click here to see the nine graphic health warnings the agency has chosen.)
Editor’s Note: Health professionals are on a slippery slope when they believe they have the inherent authority to determine what is socially acceptable behavior.
Employers burdened with mandated health insurance by the federal government will think about yet another cost when it comes hiring time; a history of illness? No job. Obese? No job. And the only solution to that would be even more government employees investigating companies for hiring discrimination. The Baylor Health Care System is already doing it. If there is any evidence you use any tobacco product of any kind, you are not getting hired.
The ANA (Association of National Advertisers) has filed a “friend of the court” brief in opposition to a series of graphic warnings required by the Food and Drug Administration (FDA) on all tobacco products and advertising.
Six tobacco companies filed a lawsuit in federal court in DC challenging the new rules and are seeking a preliminary injunction.
The new FDA Graphic Warnings Rule was mandated by Congress under the Family Smoking Prevention and Tobacco Control Act of 2009. The FDA issued its final rule on June 21.
Convenience Store News
RICHMOND, Va. — Tobacco companies are gathering support in their legal battle against the Food and Drug Administration (FDA) over new graphic cigarette warning labels. In their corner now are two advertising industry groups which joined the opposition to the new mandates on Friday.
The Association of National Advertisers and the American Advertising Federation filed briefs with the U.S. District Court in Washington, D.C. in connection with the lawsuit brought by R.J. Reynolds Tobacco Co., Lorillard Tobacco Co., Commonwealth Brands Inc. and Liggett Group LLC. The advertising groups contend the labels infringe on commercial free speech and could lead to further government intrusion if left unchallenged, according to the Associated Press.
Harvard Medical School Adviser
QUESTION: After smoking for more than 15 years, I finally quit eight months ago. I think I’m past the physical cravings, but I still miss cigarettes. I recently heard about electronic cigarettes, which vaporize nicotine and don’t create actual smoke. Are they a safer alternative to cigarettes?
ANSWER: There is no question that cigarette withdrawal symptoms are frustrating. They are the reason most people do not succeed at quitting.
Craving cigarettes is one of the hardest symptoms to deal with for many people. But whatever you do, don’t give in to the lure. If you do, all your hard work and health gains will go up in smoke.
Non-Face-to-Face Sale of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products by FDA
On Monday, September 12th, FDA informed the tobacco industry, anti-tobacco groups, and interested parties that they are preparing to consider rules which will further regulate non-face-to-face sale and distribution of tobacco products (e.g. E-commerce). Equal focus will be paid to the advertising, promotion and marketing of tobacco products sold via non-face-to-face exchange.
FDA admits in this advanced notice of proposed rulemaking (ANPRM) that the enactment of the PACT Act effectively satisfied the requirements of the Tobacco Act by requiring positive age verification and adult signatures for accepting tobacco product deliveries. Their alleged concern is whether these are enough to prevent minors from illegally obtaining tobacco products, particularly by category.
Both RFPs are intended to select pools of firms to compete for and handle communications projects over the next five years for assignments related to the Family Smoking Prevention and Tobacco Control Act passed in January 2009. That law gave the FDA the authority to address both tobacco dependence and its use by young people, nearly a decade after the Supreme Court said in 2000 that the FDA didn’t have such power.
News Record Greensboro NC
It is endlessly surprising that a newspaper whose very existence is protected by the First Amendment would so quickly brush off those same rights for an unpopular industry such as tobacco without even examining the facts. At the very least we would hope that our local paper would acknowledge that the company is entitled to a fair review of these facts in the court system, even if the News & Record is unwilling to do the same (Sept. 1 editorial, “A warning worth hearing”).
By Patricia Sullivan, Published: September 7
As a college student during the 1970s, Lawrence Deyton grew a ponytail to the middle of his back. His mother “hated it, she just hated it,” he said.
So the young man, headed toward a career in public health, offered a trade.
“Quit smoking, and I’ll cut my ponytail. She said, ‘Deal,’ ” recalled Deyton, sporting considerably less hair now. His mother quit the Pall Malls, and he mailed her the remains of his coiffure.
She lived 35 more years, said Deyton, director of the Food and Drug Administration’s Center for Tobacco Products. “In her effects, after she died, there was the ponytail.”
In CRE’s recent testimony to TPSAC we emphasized the importance of not having total abstinence as the default position. Dr. Eissenberg’s appointment is a movement in that direction.
Thomas E. Eissenberg, Ph.D.
Expertise: Psychology, Potentially reduced exposure products, Waterpipes
Professor, Department of Psychology and Institute for Drug and Alcohol Studies, and
Director, Clinical Behavioral Pharmacology Laboratory
Virginia Commonwealth University
Richmond, Virginia 23298
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Request for Nominations for Voting Members on a Public Advisory
Committee; Tobacco Products Scientific Advisory Committee
AGENCY: Food and Drug Administration, HHS.
The Daily Reveile
The head honchos at Big Tobacco recently filed suit in the U.S. District Court of Washington, D.C., against — interestingly enough — the federal government.
The plaintiffs, led by J.R. Reynolds Tobacco Company, allege that the government’s newly revealed, mandatory, graphic (read: grotesque) warning labels on cigarette packages — one of the extensive regulating powers granted the Food and Drug Administration by the Family Smoking Prevention and Tobacco Control Act of 2009 — infringe upon their constitutional rights.
I know what you’re saying — it’s a patently open-and-shut case, more smokescreen litigation, mere smoke-and-mirrors politics. You’re right. Big Tobacco is blowing smoke, for all intents and purposes.
WARNING: Reading this newspaper might cause paper cuts. Or, for Web users — WARNING: Reading this page might cause eye strain. We doubt those warnings would cause many readers to stop using Star Press products.
If this sounds silly, then one has to question the efficacy of the government forcing cigarette makers to slap graphic photos on their packages starting in 2012. The Food and Drug Administration has approved nine new warnings to rotate on cigarette packs. They will be printed on the entire top half, front and back, of the packaging. The new warnings also must constitute 20 percent of any cigarette advertising, and will include a number for a stop-smoking hotline.
The Center for Regulatory Effectiveness provided testimony to the FDA in support of advancing effective harm reduction strategies. Specifically, CRE advised the agency to state, as an overarching principle, that the marketing of modifiable risk tobacco products will be permitted when it is reasonably clear that:
1. The new product will not be more harmful than existing products; and
2. There is a reasonable scientific basis indicating the new product has the potential to reduce the risk of adverse health effects from consumption of tobacco products.
CRE’s complete testimony is attached below.
FDA is to be complimented for having an extensive outreach program to address the implementation of the agency’s Modified Risk Tobacco Products (MRTP) program.
In FDA’s words:
FDA is: announcing a public workshop to obtain input on specific issues associated with the scientific evaluation of modified risk tobacco product (MRTP) applications.
The FDA Workshop affords all stakeholders the opportunity to have an input into this important deliberative process. The Workshop is on August 25 and 26th the FDA Conference Center in Silver Spring.
The public is given the opportunity to speak on August 25 beginning at 11:00 AM.
Editors Note: As we expected, the FDA is going to be deluged by studies conducted by organizations in support of a menthol ban. The study described below is only one such study. The authors of the current study agree with CRE on one point; that the earlier studies on iniatition/cessation were mixed at best. However,the authors go on to state that they have the silver bullet study–the study of all studies on menthol.
To that claim, CRE will allow the late trumpeter Harry James ( the editors’ icon) and Helen Forrest to respond, http://www.youtube.com/watch?v=MA2hk_CIZeo
CSP/Tobacco E-News Exclusive:
NATO executive director updates industry on tobacco legislation, regulations
By Linda Abu-Shalback Zid
ROSEMONT, Ill. — “It has been a very active year, both legislatively and with FDA tobacco regulations,” Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO) told participants at the CSP 8th Annual Tobacco Category Review Meeting.
Briant then outlined some of the more recent legislative highlights:
Taxation. Out of 18 states that proposed cigarette and tobacco tax increases, only Vermont and Connecticut adopted higher cigarette and OTP tax rates, Briant informed retailers.
The Hearld Scotland
9 Aug 2011
- DIRTY HABIT: Money made from selling black market tobacco and cigarettes, like those seized at a Glasgow market, is ploughed straight back into criminal activities, the authorities say. Picture: Mark Gibson
Now, in Scotland, cigarettes are increasingly linked to organised crime through the black market, according to a new survey.
More than one in 10 cigarettes smoked in some parts of the country were sold illegally, figures published yesterday suggest.
CRE Advises FDA That Its Peer Review Plan For Mentholated Cigarettes Fails to Comply with the Peer Review Guidelines Mandated by the Data Quality Act
In an August 8 letter, attached hereto, to Dr. Deyton of the Center for Tobacco Products, CRE explains in detail the reasons that the FDA peer review fails to comply with the peer review guidelines mandated by the Data Quality Act.
CRE concludes that the FDA must take the following actions to come into compliance:
1. The agency must inform the public of how it can comment on the peer review plan and must consider any public comments.
CSP Daily News
Don’t “throttle permissible speech in cradle,” tobacco company lawyer argues
CINCINNATI — The free-speech rights of tobacco companies are improperly restricted by a federal law giving the U.S. Food & Drug Administration (FDA) the power to impose graphic warnings about the dangers of smoking and regulate how tobacco companies market and advertise their products, an attorney for the tobacco companies argued Wednesday.
According to an Associated Press report, Noel Francisco, a lawyer for R.J. Reynolds Co., told a three-judge panel from the 6th U.S. Circuit Court of Appeals on Wednesday that the Family Smoking Prevention & Tobacco Control Act is so sweeping that it stops companies from making statements that are true and not misleading.
The federal agency can now limit tobacco marketing, ban some ingredients, mandate big, graphic labels and outlaw some flavored cigarettes. And the largest tobacco companies are paying state governments billions of dollars a year under a lawsuit settlement covering health care and smoking cessation programs.
Electronic cigarettes have been removed from the shelves of Irish pharmacies due to concerns about the safety of the products.
The device allows people to smoke in areas where tobacco is banned and were invented by a
Chinese pharmacist. They offer the sensation of smoking but have no tobacco or tar. However concerns were expressed that the cigarettes could contain harmful chemicals.
The EU must now establish if the device can be classified as a medical or tobacco products
FDA has released the transcript of the July 21 TPSAC meeting. CRE has reproduced the Tozzi presentation, attached hereto, and the Hennigfield criticism:
“The fact that the FDA and TPSAC continually, for whatever reason, refuse not to address the adverse impacts of counterfeit tobacco I think puts a cloud over this proceeding because, as in a point that I will make, there are a lot of proceedings around the world that address this particular issue.”
“Initially we were going to look solely at contraband but as we got into the record we saw very clearly that in our mind a huge and very important issue is the one associated with the health effects of these cigarettes”
“FDA states: “FDA-TRACK is a new agency-wide program performance management system that monitors over 100 FDA program offices through key performance measures… Each quarter, monthly performance data is analyzed and senior managers present this data to FDA senior leadership.”
Below is an inquiry CRE made to the FDA Track and its response.
From: Jim Tozzi
Sent: Saturday, July 23, 2011 8:00 PM
To: FDA TRACK
Subject: April 4, 2011: FDA-TRACK CTP Quarterly Briefing Summary
The following is a statement from the aforementioned report.
Editor’s Note: It appears that nobody in the public health community wishes to address the adverse health effects of counterfeit cigarettes. CRE had limited success with TPSAC in that the advisory group stated that contraband had to be addressed prior to developing a regulatory regime but they did not address the health effects of contraband. The article below, like most others, addresses contraband but not the adverse health effects of contraband. Nonetheless given the increasing greater readership of our counterfeit IPD by law enforcement agences, we see some positive developments.
By FRANÇOIS DAMPHOUSSE, FREELANCE July 26, 2011
ROCKVILLE, Md. — With noted objections from tobacco industry representatives, the Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) gave a thumbs up to revisions to its report on menthol today.
The TPSAC’s Menthol Report was released in March and recommended that removing menthol cigarettes from the market would benefit public health. At today’s meeting, the TPSAC members discussed revisions to the report — which were primarily editorial in nature and do not change the March recommendation — and approved those revisions by a 8-to-0 vote.
Editors Note: bluster: “Talk in a loud, aggressive, or indignant way with little effect'”
Dr. Henningfield, a member of TPSAC, was a model of bluster yesterday at the TPSAC meeting.
Jim Tozzi of CRE made the following points:
l. There is a dark cloud over the TPSAC and FDA until it addresses the adverse health effects of counterfeit cigarettes.
2. TPSAC did not address the adverse health effects of counterfeit cigarettes.
3. FDA could revisit the matter when its draft report is subject to peer review.
CRE has completed an extensive analysis of the literature related to the adverse health impacts of counterfeit cigarettes. CRE’s analysis is included as an attachment herewith.
The analyses presented therein were conducted primarily by recognized academicians and government agencies throughout the world. The evidence is convincing beyond a doubt; counterfeit cigarettes have adverse health impacts orders of magnitude greater than legal cigarettes.
Neither TPSAC not the FDA can not ignore these findings when they address issues dealing with the regulation of the tobacco industry. Failure to do so will jeopardize the scientific credibility of both organizations.
The Power of Anti-Contraband Networking:ATF Executes Search Warrants in Contraband Cigarette Trafficking Investigation
Editors Note: CRE through this IPD as well as the Counterfeit Enforcement Forum has been leading the charge to have Federal and State enforcement agencies increase contraband enforcement. To this end CRE is pleased of the substantial readership of both of the aforementioned Interactive Public Dockets by enforcement agencies.
July 13, 2011
Contact: SA/PIO Cheryl Bishop (206) 255-5981
Or SA/PIO Brad Beyersdorf (303) 710-7643
Given the season at hand, we thought it appropriate to deviate from our customary posts to emphasize summertime in DC. Since the editor of this IPD spent time in the New Orleans music scene, there is nothing better to describe this month than a wonderful rendition of a tune from one of New Orleans most famous citizens.
By Ana Veciana-Suarez
by Alva Noë NPR
We use words and pictures to communicate. And communication comes in different shapes and sizes. Case in point: consider the very different ways the FDA and USDA have responded to the challenge of influencing the public’s attitude to smoking, on the one hand, and diet, on the other.
The USDA designed a representation of the optimal distribution of food groups in a healthful diet. The design is forcible and clear. It usefully informs the public of principles of smart eating; in this way it serves an important social goal and does so in a way that shows respect for the public at large.
Scoop Independent News
By Walter Brasch
July 3, 2011
A controversial US Supreme Court decision less than two years ago could have the unintended consequence of significantly reducing the government’s 46-year campaign against cigarettes.
In a 5–4 decision, largely along political lines, the Supreme Court ruled in Citizens United v. Federal Elections Commission (October 2009) that not only were parts of the Bipartisan Campaign Reform Act of 2002 (also known as the McCain–Feingold Campaign Reform Act) unconstitutional, but that corporations and political action committees enjoyed the same First Amendment rights as private citizens.
Philip Morris International: Illicit Cigarettes In EU Reach Record Levels In 2010: KPMG Study Shows Annual Consumption Up By 5.1% To An Estimated 64 Billion Units
CRE Note: The sale of counterfeit cigarettes continues to grow at disturbing rate with the result that the adverse health impacts associated with the wide range of contaminants in the product continue to expand. CRE’s testimony at the upcoming TPSAC meeting will highlight this trend and will release a detailed report on the same. If the sale of counterfeit cigarettes are going to be curtailed, the public, the tobacco industry and other relevant stakeholders have to convince federal governments that enforcement resources can not be overwhelmingly given to narcotics at the expense of tobacco products.
CRE Note: CRE Recognizes that the FDA does not necessarily need to be bound by the results of a particular contractor but they should give a transparent explanation for differing–which was not the case in the instance below. It is interesting that the FDA discards surveys that do not support regulation but adopts surveys, however imperfect, that supports additional regulation. For example, in one instance CRE notified the FDA of its blind acceptance of a NCI survey that supported regulation but had serious defaults; the FDA did not move to distance itself from the said survey. In another instance an NCI sponsored study concluded that menthol did not have an impact on smoking cessation and thus no need for regulation; in this instance the FDA rejected the findings. Hopefully the aforementioned cases are the extremes and are not representative of FDA actions in general. In any event, if the funding for the FDA tobacco regulators were subject to review in the annual appropriation process in lieu of funding from dedicated revenues, then there would be a public forum to discuss these important public policy issues. The use of dedicated revenues to fund the FDA tobacco center outside the normal appropriation process could be the subject of a CRE investigative study.
The Food and Drug Administration said it will issue preliminary findings on the health effects of menthol cigarettes this year after outside advisers review an internal report starting next month.
The U.S. market for menthol tobacco products is $25 billion a year, or about 30 percent of cigarette sales, according to data compiled by Bloomberg Government. Lorillard Inc. (LO) of Greensboro, North Carolina, makes the best-selling brand, Newport, with sales of $5 billion a year. Marlboro Menthol, made by Richmond, Virginia-based Altria Group Inc. (MO) and the Kool and Salem brands sold by Reynolds American Inc. (RAI) of Winston Salem, North Carolina, are other leading brands.
East Peoria Times Courrier
Scare tactics have been known to work in political advertisements, and now, members of the Food and Drug Administration are banking on the fact that such tactics will help deter smokers from lighting up.
Last week the FDA released images that will be featured on cigarette packs Each of the pictures is gory or frightening.
The proponents of a menthol ban continue to deluge the American public with studies and press statements supporting their position.
In the past several days consider:
FDA Must Ban Menthol Smokes, Louis Sullivan, Atlanta Constitution
Tobacco Giants Engage in ‘Predatory Marketing’, Stanford School of Medicine
Preceding the aforementioned actions, the American Public Health Association released a number of studies supporting a ban.
Much in the same way that water will always flow downhill, the public can expect to continue to be inundated by studies proposing a ban sponsored by organizations whose alleged mission is to protect the public health.
Merkley and Brown were joined in this effort by Senators Tom Harkin (IA), Barbara Mikulski (MD), Ron Wyden (OR), Bob Casey (PA), Al Franken (MN), Michael Bennet (CO), Jeff Bingaman (NM), Richard Blumenthal (CT), Frank Lautenberg (NJ), and Bernie Sanders (VT).
AUSTRALIA’S plan for plain cigarette packaging has drawn fire from a bloc of poor countries, many of them reliant on money from growing tobacco.
The Dominican Republic has led a push backed by eight countries at a meeting of the World Trade Organisation in Geneva, saying it had ”serious and grave concerns” that the plain packs would hurt tobacco producers in small and vulnerable economies.
An official WTO report of proceedings said ”support or sympathy” for the Dominican Republic argument came from Honduras, Nicaragua, Ukraine, the Philippines, Zambia, Mexico, Cuba and Ecuador.
South China Morning Post
One poor suburb has seen a big rise this year in gangs selling cut-price cigarettes, customs officials say
Jun 14, 2011
|The number of gangs selling illegal cigarettes in the public housing estates of Tin Shui Wai, a poor suburb, has trebled this year, and citywide seizures of contraband cigarettes have soared.|
CSP Daily News
ROCKVILLE, Md. — July 21 and 22 are dates tobacco manufacturers and convenience retailers may want to circle on their calendars. The Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) has placed both smokeless tobacco and menthol on the agenda for its two-day meeting then.
CSP Daily News
As deadline approaches, FDA explains “proposed changes” to TPSAC report
By Linda Abu-Shalback Zid
ROCKVILLE, Md. — As the deadline approaches for the Food & Drug Administration (FDA) Center for Tobacco Products to provide a menthol review status, questions have arisen about “proposed changes” to the Tobacco Products Scientific Advisory Committee’s (TPSAC) menthol report.
According to a Federal Register notice, at an upcoming meeting on July 21, “The committee will consider and deliberate on proposed changes to the report and adopt amendments that constitute the advice of the committee.”
After years of accusing the Republican Party of being “anti-science,” the Democrats are now opposing a bill that would require the FDA to base its rulings on hard scientific facts. It’s all part of the left’s latest attempt to use the FDA to ban products it’s always despised—meat, cigarettes, junk food, etc.—based on pseudo-science, ideological distaste, and conjecture. The House GOP is now fighting back with a bill from Rep. Danny Rehberg:
The top regulator in charge of putting in place the new food-safety law said Tuesday that a Republican-sponsored amendment to the Food and Drug Administration’s budget would curtail the agency’s ability to protect the public health.
The amendment cleared the House Appropriations Committee last week on a 29-20 vote. Introduced by Rep. Denny Rehberg (Mont.), it prohibits funding for FDA regulatory activity unless it is based on “hard science” and a cost-benefit analysis.
With each passing day, new evidence demonstrates the extreme adverse health impacts sustained by smoking contraband tobacco.
Nonetheless the public health community refuses to address this matter. Why? CRE suspects that the public health community simply can not come to grips with the simple fact that if one is to smoke they are better off smoking legal products than illegal products.
It appears that a fair number of the public health community believe if you ignore a problem it will go away.
Increasing Public Access to Federal Contract Information – Reinvigorating the Data Access Act: Center for Regulatory Effectiveness in Science Magazine
WASHINGTON, May 30, 2011 /PRNewswire-USNewswire/ — The Data Quality Act continues to be used by the public to correct erroneous information disseminated by the Federal government. However, its companion legislation goes virtually unnoticed because OMB under the Clinton Administration emasculated the statute by prescribing overly restrictive regulations which were infinitely more limiting than required by statute.
The Data Access Act states that federal agencies must make available to the public all research and underlying data developed under a federal award. The term “all” means all; OMB in its implementing regulations stated, however, that the only reports covered by the Data Access Act were those reports which carry the “force and effect of law”, meaning only those reports which change one’s legal rights — a tiny fraction of the reports which were to be covered by the Act.
CRE Note: Subsequent to the issuance of the TPSAC report a number of groups are flooding the market with additional studies which, in the mind of the authors, highlight the need for additional regulatory action on menthol. Surprisingly, none of the studies address the central issue identified by CRE: A menthol ban will result in the introduction of contraband cigarettes which present a far greater threat to smokers and non-smokers than legal products. It seems the public health community does not want to recognize publicly, even though they are convinced of the accuracy of the underlying data compiled by CRE because they have never criticized it, that if one is to smoke, you had better not smoke contraband.
‘Hard Science’ Approps Amendment Stemmed From Antibiotic Concerns
The full House Appropriations Committee’s approval of an amendment to the FDA spending bill Tuesday (May 31) that would mandate the agency base its guidance or regulations purely on “hard science” stems from a lawmaker’s concerns that FDA might limit antibiotic use in animals based on contentions that utilization of these drugs on the farm promotes antimicrobial resistance of bugs in humans. The measure garnered substantial opposition from key Democrats, FDA and many other stakeholders, with the amendment possibly set to be stripped from the bill before it hits the floor because it is not germane to appropriations and would better suit consideration by an authorizing committee.
Congressman Denny Rehberg of Montana offered the following amendment which was adopted by the House Appropriation’s Committee:
“None of the funds made available by this Act may be used by the Food and Drug Administration to write, prepare, develop or publish a proposed, interim, or final rule, regulation or guidance that is intended to restrict the use of a substance or a compound unless the Secretary bases such rule, regulation or guidance on hard science (and not on such factors as cost and consumer behavior), and determines that the weight of toxicological evidence, epidemiological evidence, and risk assessments clearly justifies such action, including a demonstration that a product containing such substance or compound is more harmful to users than a product that does not contain such substance or compound, or in the case of pharmaceuticals, has been demonstrated by scientific study to have none of the purported benefits.”
CRE Brazil reports:
|New Rules for Exporting Cigarettes|
|The Federal Revenue Office established a series of norms to avoid cigarettes exported by Brazilian industries returning to the Country as contraband. Now, products destined to be sent abroad will have a special bar code on their packages which will store all the producer’s data. Companies that make the appropriate changes will be exempt from export taxes which are equivalent to 150% of the market value.Packages of cigarettes sold in Brazil will have to include the following inscription: “For export only – The selling of this product in Brazil is prohibited.” If an inspection catches these products circulating in the national market, they will be considered illegal merchandise resulting in serious fines.|
CRE Note: Every President since Ronald Reagan has instituted a program to review existing regulations and every President since Ronald Reagan has been criticized for both killing regulations and failing to kill them. The article that follows demonstrates that the Obama Administration is suffering a similar fate.
A far more useful approach is for the critics to present their arguments in a coherent and systematic manner using an Interactive Public Docket (IPD) not controlled by the federal government. One such IPD is available here.
Dan Froomkin Huffington Post
The thirtieth anniversary of OMB’s regulatory review office, OIRA–the Office of Information and Regulatory Affairs, was celebrated on Friday, May 20th. The event was sponsored by Susan Dudley, a former OIRA Administrator, who presently heads the George Washington University Regulatory Studies Center.
Virtually all former Administrator’s and Deputy Administrators made presentations, including Jim Tozzi, the first Deputy Administrator of OIRA.
The Bureau of National Affairs Reports:
Jim Tozzi, the first deputy administrator of OIRA, said the institution gives a protective shield against the wholesale dismantling of regulatory agencies, which play an integral role in society.
CRE Note: In the article below the author states: “Ashley also assured industry representatives that the agency’s decision-making on tobacco regulation would be based on solid scientific evidence.” Dr. Ashley personally addressed the CRE Data Quality petition; based upon Dr. Ashley’s actions to date CRE concludes that his actions are going to be science-based.
Richmond Times Dispatch
Some tobacco industry representatives expressed frustration Monday with how the U.S. Food and Drug Administration has handled its regulatory authority over tobacco products so far.
CRE Note: FDA needs to establish guidance which would allow tobacco manufacturers to address claims of “reduced harm”. FDA awaits the report of the IOM which appears to be in the distant future.
By DAVID KESMODEL Wall Street Journal
Tobacco giant Reynolds American Inc. is seizing on new antismoking laws in New York City this week to launch an advertising campaign for Camel Snus, its small but growing smokeless brand.
Full-page ads beginning Monday in The Wall Street Journal, USA Today, the New York Daily News and other newspapers will urge smokers to drop their cigarettes for Camel Snus, a type of spitless oral tobacco that comes in pouches.
CRE Note: The establishment of a FDA office dedicated to the regulation of the tobacco industry has generated a cottage industry focused on implementing an ever increasing volume of regulations. Fortunately none of the studies submitted can be used by the FDA until which time the FDA determines they are compliant with the Data Quality Act. Those stakeholders interested in addressing the following studies should submit their analyses by posting on the comments section below or providing financial support to CRE to do the same.
Medical News Today
CRE Note: Rest assured, the release of the TPSAC report on menthol represents the launching point of a contentious debate and a prolonged regulatory review. Well financed anti-menthol groups will flood the regulators with a series of studies aimed at moving the FDA to regulate menthol. CRE will be responding to these studies to ensure that the resultant regulatory docket is not one-sided. CRE can not carry this load alone due to constrained resources; our readers are encouraged to post relevant comments in the section below and they will be used in the preparation of the CRE analyses which will be forwared to the FDA. (Detailed studies can be posted in the Concepts and Studies Discussion Forum)
CRE Note: Mr. Sullum we agree with your point ” For both practical and moral reasons, I don’t agree that banning menthol cigarettes is a good idea, any more than banning cigarettes in general would be.” We differ however with your assertion that one action that is not science-based (banning all flavors other than menthol) should be corrected by taking another non-science based action (banning menthol).
Jacob Sullum | May 9, 2011 Reason Magazine
CRE Note: It would be interesting to compare New Zealand’s risk reduction paradigm compared with that to be used by the FDA.
The Ministry of Health has stated that electronic cigarettes are “far safer” than smoking tobacco.
The statement – made to MPs – has been welcomed by End Smoking trust chairman Dr Murray Laugesen, who is investigating e-cigarettes as a quit-smoking tool.
“End Smoking NZ congratulates the NZ ministry on possibly being the first ministry of health to concede e-cigarettes are safer than smoking.”
Two perspective pieces addressing the menthol cigarette problem appear in today’s New England Journal of Medicine. One, by ACSH advisor and Boston University School of Public Health Professor Dr. Michael Siegel, argues that, by refusing to recommend clearly that the FDA ban menthol cigarettes, the Tobacco Products Scientific Advisory Committee (TPSAC) contradicted the scientific literature featured in its report and thus failed in its mission to provide a public health solution.
CRE Note: Dr’s Benowitz and Samet know the menthol issue well because of their leadership role in TPSAC.
What is surprising is the statement: : “The TPSAC, a scientific advisory committee, was not charged with addressing regulatory options and did not have the time or expertise to analyze regulatory scenarios, including any involving inadvertently opening a door for the introduction of contraband menthol cigarettes into the U.S. market”.
CRE agrees that the magnitude of contraband is outside the purview of TPSAC but a review of the health effects of contraband is not. CRE provided in written and verbal testimony to TPSAC considerable data from governmental authorities which demonstrated that the health effects of contraband were immense compared to legal cigarettes.
The Ban on Menthol Cigarettes Can Help Close the Health Disparities Gap: Center for American Progress
CRE Note: We are publishing the following article to demonstrate the challenge before opponents of the menthol ban; more specifically the FDA is being bombarded with biased articles which lack a sound science foundation. Not only does this article neglect to say that the smokers of interest will switch to contraband which has demonstrated adverse health effects significantly more severe than legal cigarettes but it makes determinative conclusions regarding the impact menthol has on smoking initiation/cessation which is not substantiated by the record. Fortunately because of the considerable traffic on this Interactive Public Docket (IPD) devoted to TPSAC, rejoinders to these inaccurate statements are being broadcast throughout the web community.
April is Minority Health Month so one can expect a number of articles written on the FDA menthol issue. We print this one because it is representative of a major argument which is omitted from the proponents of a menthol ban. If one is interested in protecting the health of minorities, then an action should be taken to shield minorities from the onslaught of violence which would occur from organized crime cells operating primarily in their largest markets—minority populated areas– through the sale of contraband.
CRE discussed these points in its submission to TPSAC.
Editors Note: The proponents of a menthol ban conveniently forget to mention a key recommendation of TPSAC namely: “ Should FDA choose to implement a ban…FDA would need to assess the potential for contraband menthol cigarettes as required by the Act.”.
Continued neglect of this key recommendation suggests that the proponents of ban realize that contraband considerations will dominate the debate since other considerations are either non-existent or mixed as outlined in the industry report on menthol.
FDA, as a matter of law, will have to address the fact that contraband cigarettes impose extremely adverse health effects on both smokers and non-smokers—the unilateral recommendation in the following article is the bow of a sinking ship.
Editors Note: The regulation of e-cigarettes will require FDA to develop a harm reduction program that complies with the Data Quality Act and reviewable by TPSAC.
Agency Will Not Regulate E-Cigarettes Under the Stricter Rules That Apply to Medical Products
WebMD Health News
April 27, 2011 — The FDA has decided to oversee electronic cigarettes the same way it does tobacco products. The agency will not regulate the vapor-producing devices under the stricter federal rules that apply to medical products.
Editors Note: Unlike the statement of Senator Blumenthal the AP story is complete with respect to the TPSAC recommendations”
‘The panel stopped short of recommending an outright ban, saying the FDA should consider other factors, including whether a ban could increase the market for counterfeit and smuggled cigarettes.”
CEO Murray Kessler of Lorillard Inc. — the third-largest U.S. tobacco maker, whose biggest brand, Newport, is the nation’s top-selling menthol cigarette — spoke during a conference call with analysts Tuesday about a report on menthols from a Food and Drug Administration advisory panel.
By Michael Felberbaum, The Associated Press – 1 day ago
RICHMOND, Va. — The Food and Drug Administration wants to get schooled in cigarette making.
The federal agency’s 2-year-old Center for Tobacco Products is asking tobacco companies to invite it to tour farms and factories that grow or process tobacco.
It says the visits are meant to help the agency better understand how each step in the process — from field to package — could influence the final product.
The FDA wants to tour large and small cigarette factories, a smokeless tobacco plant, tobacco farms, a rolling-paper factory and a tobacco warehouse.
Editors Note: When a US Senator states that an action to ban menthol cigarettes is based upon on the TPSAC report, he has not read the report in its entirety. The TPSAC made it clear that no action can be taken on a ban until the issue of contraband has been addressed. CRE has an Interactive Public Docket entitled Counterfeit Cigarettes: An Enforcement Forum which is dedicated to the contraband issue.
Editors Note: There is considerable data to demonstrate that plain packaging increases contraband. See Counterfeit Cigarettes: An Enforcement Forum
Sydney Morning Hearld
WHEN the Rudd government’s National Preventative Health Taskforce released a position paper on anti-tobacco measures, they titled it ”Making Smoking History”.
If that was the goal you’d think the government could just ban cigarettes – a clear, bold, unequivocal stance on what it has condemned as a very dangerous and addictive product
Issue Date: CSP Daily News, April 15, 2011
By Linda Abu-Shalback Zid
LAS VEGAS — When it comes to tobacco regulation, Dr. Lawrence Deyton, director of the FDA’s Center for Tobacco Products (CTP), acknowledges that there might be discord on occasion. But as he told retailers and manufacturers at the NATO Show Thursday, communication is an important focus of the CTP, even during those times.
“We want to establish a relationship of good communication and trust,” he said. “We may not always agree on everything. But we can disagree on things, but we don’t need to be disagreeable. And we need to keep communicating with each other about how this is all going, so that we can all learn for each other.”
Plain packaging may require up to $3.4 billion taxpayer gift annually to big tobacco and film companies
Bad anti-intellectual property laws by State and Federal Parliaments could require taxpayers to gift up to $3.4 billion per year in compensation to film companies and big tobacco for the loss of their trademarks”, Director of the IP and Free Trade Unit at the Institute of Public Affairs, Tim Wilson, said today.
Mr Wilson’s comments follow the release of a new IPA report, Governing in ignorance: Australian governments legislating, without understanding, intellectual property, released today for World Intellectual Property Day.
Center for Public Integrity Reports on Potential Multi-Billion Dollar Overpayment by Tobacco Companies
The Center for Regulatory Effectiveness has established an Interactive Public Docket dedicated exclusively to the discussion of counterfeit cigarettes. Counterfeit cigarettes play a crucial role in understanding many tobacco-related public policy issues ranging from a proposed ban on menthol flavoring to overpayment by tobacco companies under the 1998 settlement.
CRE has posted on the Counterfeit Cigarette IPD an article prepared by the Center for Public Integrity on an arbitration hearing to determine the extent of tobacco industry overpayment to states under the 1998 settlement. As the article explains, the marketshare held by counterfeit cigarettes is one of the issues being considered. The Center for Public Integrity article may be found here, http://www.thecre.com/cc/?p=134
Editor’s Note: What is the metric to be used to judge anti-smoking therapies? “Modified Risk” determinations are to apply to the entry of new tobacco products; should the metric being developed by the Institute of Medicine apply to anti-smoking therapies?
Siegel: Rest of the Story
The black box warning for Chantix notes the following:
A study says the products are more hazardous and addictive, but a journal article says they are no worse than other cigarettes.
By Alicia Gallegos, amednews staff. Posted April 6, 2011.
Menthol cigarettes have a higher risk of causing tobacco-related diseases than other cigarettes and should be pulled from shelves, according to a report by the Food and Drug Administration’s Tobacco Product Scientific Advisory Committee.
About the TPSAC’s actions, Dr. Blum writes: “Unfortunately, the committee that produced this sobering report did not translate its conclusion into a recommendation that menthol be banned. Instead, the committee fretted about a potential black market for menthol cigarettes and the possible introduction of do-it-yourself menthol cigarette kits to circumvent such a ban. But this reasoning puts the cart before the horse. In the end, the committee proved weak-willed.”…”The horrific impact menthol cigarettes have had on the African-American community warrants that all health organizations and everyone concerned about the rising cost of health care urge the FDA and Congress to add menthol to the list of far less widely consumed but already banned candy flavorings.”
Unlawful trade in cigarettes, particularly smuggling and counterfeiting, undermines the inflow of government revenues, encourages organised crime, misleads consumers with products whose quality is doubtful, and hampers efforts to prevent consumption by minors. This unfair practice stunts the growth of the brands of the British American Tobacco Group in several countries, lowering the values of investments in distribution and weakens the systems regulating the legally-established side of this industry.
Editors Note: The NCI announcement is of particular interest to CRE because the reviewability of the Data Quality Act was not addressed by the Ninth Circuit in ASA v. HHS; the court claimed that the thrust of the petition was being addressed in another forum—the rescheduling petition described below which has seen no movement for a nearly a decade. In Prime Time the DC Circuit found the DQA to be binding on agencies. The NCI announcement provides a basis for a reconsideration of the Ninth Circuit decision because it emphasizes that the ASA venue is the only practicable forum for the introduction of the new information.
The company submitted a report on the use of menthol in cigarettes to the FDA
RICHMOND, Va. – Altria Client Services on behalf of Philip Morris USA Inc. has sent the U.S. Food and Drug Administration a written report summarizing the science and evidence on the impact of the use of menthol in cigarettes on the public health. The FDA asked the tobacco industry to provide a separate report on the topic to the Tobacco Products Science Advisory Committee (TPSAC), which recently released its findings that there is scientific evidence to back up the notion that removing menthol cigarettes from the market would benefit public health in the United States. Lorillard Inc. issued its own response to the findings.
From: China Tobacco/Shandong Provincial Tobacco Monopoly Bureau
Editor’s Note: Translation courtesy of the Center for Regulatory Effectiveness
Although China’s is working to crack down on counterfeit cigarettes, the manufacturing and sale of fake smokes is a covert activity that changes location, has the strong ability to regenerate. Counterfeit cigarette cases are increasingly complex. The counterfeit cigarette trade is conducted by large organizations and results in the loss of State revenue. The high level of chemicals in counterfeit cigarettes will affect the health of people to a certain extent. If the problem of counterfeit cigarettes is not solved as soon as possible, is bound to affect the healthy and orderly development of China’s tobacco market as a whole. So, what are the harms from making and selling fake cigarettes?
By Jennifer LaRue Huget Washington Post
The federal government is contemplating banning menthol cigarettes on the grounds that they pose a substantial public-health risk.
But federally funded research published this week seems to weaken that argument.
An Food and Drug Administration prohibition on the sale of menthol cigarettes would parallel its ban on other flavored cigarettes in 2009. At issue is whether menthol cigarettes, perhaps because they may taste less harsh than others, might lure more people, particularly young ones, into smoking.
It’s not often a tobacco company gets released from government regulation without asking.
But that’s apparently what happened to Star Scientific Inc. after it asked the Food and Drug Administration to treat two versions of its smokeless, dissolvable tobacco lozenges as “modified risk” because they contain lower levels of carcinogens than other tobacco products.
A Food and Drug Administration advisory committee on Friday said banning menthol cigarettes will be a boon to public health, especially among young people and African-Americans, for whom mentholated brands are often a gateway to lifetime smoking.
But strategies that are good for public health are starting to adversely affect federal and state revenues. Raising taxes on the declining number of people who smoke has finally reached a tipping point with revenues generated by cigarette taxes starting to fall, according to government documents and data provided by the Campaign for Tobacco Free Kids. A menthol ban would accelerate the trend.
CRE applauds HHS for their compliance with their Data Quality Act (DQA) guidelines which require the agency to notify petitioners when additional time is required to complete a response to a Request for Correction. HHS expects that response to CRE’s petition will be provided by May 19, 2011.
CRE’s DQA petition may be found here.
HHS’ letter is attached below.
TPSAC Concludes: “Should FDA choose to implement a ban…FDA would need to assess the potential for contraband menthol cigarettes as required by the Act.”
The above statement is contained in the TPSAC report on menthol. CRE compliments TPSAC for its recognition of the significant impact contraband will have on increasing youth access to cigarettes, exposing smokers to unacceptably high levels of toxic metals and exposing both smokers and non-smokers to an increase in violence as a result of funding organized crime and terrorists groups.
FDA’s review should be augmented by an orderly examination of the contraband issue by academics, enforcement officials and the public. To this end, CRE has under consideration the establishment of an Interactive Public Docket (IPD) dedicated to contraband.
Shares in tobacco firm Lorillard closed up 10.6% at $87.11 after fears of a US ban on menthol cigarettes were reduced.
A report by the US Food and Drug Administration (FDA) called for more research before a decision could be taken, rather than saying a ban would help improve public health.
Lorillard owns the best-selling Newport menthol cigarette brand.
MF Global Holdings analyst Mark McMinimy said it was “very unlikely” the FDA would ban menthol cigarettes.
“If you’re calling for more research, how can you call for something like removing menthol cigarettes from the market, which seems very final?”
SILVER SPRING, Md. — Taking menthol cigarettes off the market would benefit public health, the Food and Drug Administration’s Tobacco Products Scientific Advisory Committee concluded Friday after a year of reviewing the issue.
Panel members stopped short of recommending specific regulatory action by the FDA, such as banning menthol cigarettes, which are preferred by about 30% of smokers overall and 80% of African-American smokers. Minty menthol has been the only cigarette flavor on the market since Congress gave the FDA regulatory authority over tobacco products in 2009.
Note to Ms. Vargyas : We believe you are conveniently ignoring the magnitude of the contraband problem when you state:
“I’m sure there are going to be some illegal-trade cigarettes” Please read CRE and ATF data on this matter at http://www.thecre.com/tpsac/?p=777
Note to Dr. Siegel:
Unforunately CRE believes that some members of the TPSAC share the observation that politics not science should govern TPSAC activities when you state:
“If the flavorings which almost no one smokes are banned, then how can we not ban the one flavoring which actually does entice kids to smoke?”
Tobacco industry report says menthol cigarettes no riskier than regular cigarettes, but not all agree
CBS News/AP Wire
The federal agency is considering banning the minty cigarette flavoring that makes menthols different from other smokes. Many health experts, including an FDA advisory panel, say consumers seem to think menthol flavoring offers health protection or benefits, and menthol cigarettes are disproportionately marketed to African Americans.
Editors Note: Obviously TPSAC can spend its limited resources in the manner it sees fit such as historical and outdated marketing scenarios; CRE believes it more significant that TPSAC address the shortcomings in the initation/cessation studies as addressed in the CRE Data Quality petition at http://www.thecre.com/tpsac/wp-content/uploads/2010/09/TPSAC-FDA-DQA-Petition-09.18.10-f.pdf and so reported in FDA Week http://www.thecre.com/tpsac/?p=592
By Jenifer Goodwin
THURSDAY, March 17 (HealthDay News) — Marketing messages for menthol cigarettes disproportionately target youths and blacks and are crafted to imply that menthols are safer than other cigarettes, although they are not, according to a newly-released draft section of a long awaited FDA advisory committee’s report.
Credit and equity investments to play amid scrutiny of the menthol category
By Philip Gorham, CFA | 03-16-11
Philip Gorham is a Senior Stock Analyst for Morningstar
After taking control of tobacco regulation in 2009, the U.S. Food and Drug Administration (FDA) is investigating the use of menthol in cigarettes. Its tobacco panel, the Tobacco Products Scientific Advisory Committee (TPSAC) is due to report its findings by March 23, 2011, and the FDA will issue a binding ruling after that. We envision three ultimate outcomes: menthol is banned (6% probability); no action is taken against menthol (16% probability); no ban, but tighter regulation (78% probability).
Several respondents raised questions concerning the scope and utility of the data being requested by the FDA.
“Congress excluded from the criteria for substantial equivalence under § 910(a), and for reporting under § 905(j), any consideration of behavioral effects such as initiation or cessation, or of consumer perception studies. This absence shows Congressional intent that the criteria should not be considered in the substantial equivalence evaluation.”
Altria quotes the following statement in an IOM report in support of its conclusion:
Medical device pathway gets touch-ups
Published in Packaging World Magazine, March 2011 , p. 28
Written by Eric F. Greenberg | Attorney-at-Law
It might soon get easier to be OK with the 510(k).
The very common FDA clearance process for medical devices, called “510(k) notice” after the section of the law, is supposed to be a swift path to market, but it’s not always so.
What’s more, although large swaths of the device industry have been exempted from having to file a 510(k) notice before entering the market, those companies that do have to file 510(k)s will often struggle with knowing exactly what’s expected of them.
Japan Tobacco and Swedish Match on “Substantial Equivalence”: Support for the 510(k) Program as a Model
Japan Tobacco and Swedish Match, among others, state their support for the 510(k) medical device provision as a model for substantial equivalence in the tobacco program, they state:
The 510(k) Program Provides A Clear Model For An Effective Pre-Market Review Program
“If FDA determines that the proposed device is “substantially equivalent” to a legally marketed predicate device, FDA will issue a letter “clearing” the device for marketing. In implementing these provisions, FDA noted that it “should not require a premarket notification for every change…since too many…changes are made on a regular basis.”FDA concluded that changes with little to no impact on health should be exempt from the substantial equivalence filing requirement, and issued regulations establishing that only those modifications that could “significantly affect the safety or effectiveness of the device” or that constitute a “major change or modification” in the device’s intended use require a submission under Section 510(k).”
Enactment of the proposed amendment to Chapter 34 of the Revised Ordinances to the City of Fall River (1999) would ban the sale of tobacco products at retail establishments that also operate or maintain a health care institution within it, such as a pharmacy or drugstore.
As presented, the amendment is a deliberate intervention by local government officials to institute a restraint against lawful trade and commerce in Fall River. Government action that obstructs lawful trade cannot be disregarded as trivial. Nor can it be supported in principal by an organization that represents the interests of local businesses.
In adherence with their statutory duty, GAO has released the first part of its report on contraband tobacco. The report analyzes the illicit cross-border trade in cigarettes with a focus on tax evasion schemes. GAO explained that their second report, to be released later in 2011, will discuss “the health effects from cross-border and illicit trade.”
Based on information from the Treasury Department, report explains that “the diversion of tobacco products occurs for two principal reasons: the potential for illicit gains is high and the risk to illegal operators is low.”
Director of Media Relations, Drug Policy Alliance
From a leading blog in England:
“Well, well, well. Who would have thought that the USA could have something as effective and efficient as the Center for Regulatory Effectiveness (CRE)? And, perhaps more to the point, who would have believed that such an agency would openly (and with authority!) challenge the FDA?”
See complete post .
by Philip Gorham | 01 Mar 11
Morning Star Equity Analyst in Toronto Star
Two draft chapters of the upcoming report into the use of menthol by the Tobacco Products Scientific Advisory Committee (TPSAC) point to a relatively benign outcome to the Food and Drug Administration’s (FDA) investigation into menthol. We continue to expect measures to be taken against the menthol category that will not have a material impact on equity valuations. Our fair value estimates for the industry remain in place. We think the industry is fairly valued at present, but Lorillard, which stands to be most impacted by the outcome of the FDA review, still offers around 15% upside, even if the FDA imposes some restrictions.
Editors Note: See CRE Press Release
The TPSAC is moving toward completion of its assigned task, producing a report on menthol in cigarettes—with all the drama inherent in Broadway Theater. What will be their ultimate decision?
Attached below is the Center for Regulatory Effectiveness’ statement at the March 2nd TPSAC meeting.
An FDA advisory panel’s draft report about menthol cigarettes helps make the case for Lorillard shares.
Lorillard, whose Newport brand is the top selling menthol cigarette, saw its stock rise Tuesday after a Food and Drug Administration advisory panel said menthol cigarettes pose no added health risk.
Late Monday, advisors to the Food and Drug Administration posted two chapters of their report on menthol cigarettes. In one chapter, the panel found that there is insufficient evidence to conclude that smokers of menthol cigarettes face any different or greater health danger than those who smoke regular cigarettes.
March 2, 2011
Adding menthol to cigarettes may increase the likelihood of addiction and make it easier for young people to start smoking, according to preliminary findings of a Food and Drug Administration advisory panel.
* FDA releases partial draft from menthol committee
* Lorillard shares up 1.6 pct
* Analysts: proposal may not change final view on ban
* Agency also kicks off dissolvable tobacco review (Adds more details on smokeless tobacco, reaction; updates share prices)
By Susan Heavey
WASHINGTON, March 1 (Reuters) – Some U.S. advisory panel members say there is a lack of evidence to show menthol cigarettes expose smokers to higher risk of disease, boosting shares of top-menthol maker Lorillard Inc (LO.N) on Tuesday.
WASHINGTON Adding menthol to cigarettes may increase the likelihood of addiction and make it easier for young people to start smoking, according to preliminary findings of a Food and Drug Administration advisory panel considering whether to recommend a ban or otherwise restrict menthol cigarettes.
The Tobacco Products Scientific Advisory Committee said the scientific evidence showed that “menthol has cooling and anesthetic effects that reduce that harshness of cigarette smoke” and this reduction “could facilitate initiation or early persistence of smoking by youth.”
By Molly Peterson – Mar 1, 2011 12:01 AM ET
“The evidence is insufficient” to conclude that menthol smokers face a different disease risk than people who use regular cigarettes, said advisers to the Food and Drug Administration. Still, menthol may make smoking more addictive, the panelists said. The comments were posted yesterday on the FDA website in two draft chapters of a report the panel must submit by March 23.
Editors Note: CRE will be making periodic reports on the recent action taken against FDA/TPSAC. CRE has a website dedicated to such actions, titled FACA Under Fire Influential regulators have followed the reports on these sites for years, see archives
Grasping at Straws: “Making wild and often times unbelievable assumptions or using far fetched ideas and possibilities to reach the desired conclusion”. (Urban Dictionary)
ABC News reports:
“Two of the nation’s largest cigarette makers on Friday asked a federal court to stop the Food and Drug Administration from relying on recommendations made by an advisory panel on issues such as menthol cigarettes.”
FDA’s Tobacco Advisory Committee’s Failure to Address the Health Effects of Contraband Cigarettes is an Invitation to a Legal Challenge
FDA’s tobacco advisory committee continues to ignore statements by the Center for Regulatory Effectiveness that its organic statute requires it to address the negative health impacts of contraband cigarettes, see http://www.thecre.com/tpsac/?p=1119
Consequently, in the attached letter CRE is requesting that the General Counsel of the FDA apprise the FDA Center for Tobacco Products and TPSAC of their statutory responsibilities to study, and report, in detail on the well documented negative impacts that counterfeit cigarettes have on the health of smokers and the violence sustained by non-smokers resulting from attacks by drug cartels.
The letter states, in part,
- Written By: TOB Editor
The Center for Regulatory Effectiveness (CRE) has informed the US Food and Drug Administration and its Tobacco Products Scientific Advisory Committee that “contraband cigarettes pose a serious health problem and that TPSAC is required by statute to address this issue in its study of menthol.”
The CRE sent the FDA three documents that make its case for the FDA’s responsibilities regarding counterfeit cigarettes. Those documents contain information regarding the health risks posed by counterfeit tobacco products and wording in the law that created the TPSAC requiring it to protect public health.
Editors Note: CRE is interested in the views of the e-cigarette community on the February 17 post http://www.thecre.com/tpsac/?p=1119 which describes the extremely adverse health effects sustained from smoking counterfeit cigarettes.
Who is CRE?
CRE is a regulatory watchdog which ensures that federal regulators do not exceed their statutory charge to regulate. In doing so CRE acts to ensure that federal regulators comply with the “good government” laws which “regulate the regulators”.
The “good government” laws include the Data Quality Act, the Paperwork Reduction Act and Executive Order 12866-regulatory review.
Center for Regulatory Effectiveness (CRE) Provides FDA with Evidence Which Compels an Examination of the Health Effects of Counterfeit Cigarettes
Notwithstanding a law that directs the FDA Tobacco Advisory Committee to review the health effects of counterfeit tobacco, the Tobacco Advisory Committee continues to ignore the law. In response to this dereliction of duty, the Center for Regulatory Effectiveness sent the following email to the FDA and its Advisory Committee.
It should be noted that when FDA regulates tobacco it is imperative that it not be able to pick and choose at will which studies are to be considered and those which are to be ignored; it must examine the totality of the record. It is difficult to understand why an agency charged with protecting public health would not want to examine the health effects of counterfeit cigarettes which are recognized throughout the world as having a demonstrable record of extremely adverse health impacts.
Editor’s Note. Leading articles on te 510(k) process for medical devices are posted herein because they are based upon the term “substantial equivalence”– the same term applied to new tobacco products in the recently enacted tobacco control legislation.
January 21, 2011 | Reed Miller
Silver Spring, MD – The FDA has outlined plans to make the 510(k) device clearance process “more predictable and smarter” but acceded to industry pressure by declining to act yet on some of the most controversial issues . The news is being hailed by industry advocates as progress and booed by critics who call the plan “not forceful enough.”
Editors Note: Please view the following to ascertain the public acceptance of this message.
CNBC covered the CRE press release .
Youth Use of Contraband Cigarettees Out of Control In Ontario .
Read News Feeds Which Carried the CRE Press Release Throughout the US
NO RESPONSE FROM FDA
— CRE Press Release —
At today’s TPSAC meeting, the committee presented its outline of topics to be reviewed in its analysis of the contraband which will result if there were a ban on menthol cigarettes.
An e-cigarette is a battery-powered tube that looks like a regular cigarette but instead of tobacco, it houses a battery-operated heating element that turns a liquid ingredient into a vapor mist which is inhaled into the lungs like a traditional cigarette. According to USA Today, more than one million Americans claim to have used the device to quit smoking since it first became available in the United States in 2006.
In case you somehow missed it, President Obama has quit smoking. That’s right, the Commander in Chief no longer smokes. And while there’s no clear word on Obama’s chosen method — cold turkey, nicotine gum, etc. — we wonder if he gave any thought to a cessation tool that’s been getting a lot of attention recently. The electronic cigarette.
So what, pray tell, is an e-cigarette? It’s a smokeless, battery-operated mechanism — either plastic or metal — that heats a liquid nicotine solution, letting users inhale doses of nicotine in vapor form. E-cigarettes don’t contain tobacco or create smoke, which is why manufacturers claim they “provide you with a similar experience without the tar and second-hand smoke that is related to traditional smoking.”
The TPSAC Interactive Public Docket is rapidly becoming a forum for informed public comments on tobacco issues. CRE appreciates your continued visits to the site.
Members of the public are encouraged to express their views on tobacco issues on the Studies and Concepts forum on the right hand side of this page–no registration is needed. CRE will post leading comments on the home page.
CRE is impressed with the thoughtfulness of the comments received on e-cigarettes, see http://www.thecre.com/tpsac/?p=1027
Those members of the public who wish to supply additional comments or studies on e-cigarettes are encouraged to post them on the “Studies and Concepts Forum” on the right hand side of this page at http://www.thecre.com/scur/.
Each article is also equipped to take comments.
CRE Assessment of Questions Raised by the NCI Presentation to TPSAC: “What Menthol Smokers Report They Would Do If Menthol Cigarettes Were No Longer Sold”
In a January 10, 2011 presentation to TPSAC, Ms. Anne Hartman1, a representative of NCI, used the newest May 2010 Tobacco Use Supplement to the Current Population Survey (TUS-CPS) data to allege that:
1. Overall 39% of menthol smokers say they would quit all tobacco use if menthol cigarettes were no longer sold”.
2. Behavioral intention is associated with actual behavior-therefore, results suggest a potential substantial reduction in tobacco use if menthol cigarettes were no longer sold”.
See the attachment for the complete article.
Also attached are two influential studies regarding the relationship between intention/behavior.
TPSAC is making a deliberate effort to complete its first major undertaking; a report on menthol in cigarettes.
TPSAC is to be complimented for writing the report from scratch in lieu of marking up a draft prepared by FDA.
Much to its credit TPSAC has released a draft of the first two chapters of the report, available here .
TPSAC is conducting the review in an open and transparent method and has made every effort to accommodate public comments.
CRE encourages its readers to offer comments on these chapters on this post.
“Editors Note: The CRE Board is reviewing a proposal to have CRE follow in detail regulatory actions related to e-cigarettes. Also see the previous post on this topic at http://www.thecre.com/tpsac/?p=1027. The following is taken from ECF’s Forum at http://www.e-cigarette-forum.com/forum/campaigning-discussions/155402-public-participation-forum-fda-advisory-committee-tpsac.html
A Public Participation Forum for the FDA Advisory Committee (TPSAC)
Question: Does anyone know anything about this website:
January « 2011 « A Public Participation Forum for the FDA Advisory Committee (TPSAC)
”A Public Participation Forum for the FDA Advisory Committee (TPSAC).
I have been looking around on the net to find wesibtes where I can leave comments. Does anyone esle feel that this something worth doing?”
February 7, 2011 by Staff
The National Black Police Association (NBPA) has a firm foundation, a strong commitment, and an unbreakable connection to the Black community. The NBPA is obligated to address any issues in the Black community that are not equitable, fair or just. Our role is advocacy and activism to protect the greater good.
WASHINGTON — The Justice Department plans to ask a federal judge to make public the proposed statements the government wants tobacco companies to publish about the dangers of their products.
Department spokesman Charles Miller said the agency planned to file the proposed statements in a Washington, D.C., court Thursday, but ran into resistance from cigarette makers about whether the information should be made public now.
“It was our understanding that this would be publicly filed, but there is a difference of opinion on that,” Mr. Miller said.
Editors Note: CRE looks forward to FDA’s program to allow the public to express its views on this matter as well as the weight to be accorded to the Data Quality Act in making the resultant determination.
Tobacco maker Star Scientific Inc. is asking the Food and Drug Administration to certify a moist smokeless tobacco it has developed as less harmful than other forms of tobacco on the market.
The small Virginia company said Wednesday it has filed an application with the FDA to approve its Stonewall Moist-BDL as a “modified risk” product under the 2009 law that gave the FDA authority over tobacco.
Editors Note: CRE is receiving a substantial volume of comments on menthol. We are particularly impressed with the thoughtfulness of the comments. Based upon our experience in running a number of IPD’s, when public participation on an IPD increases there is a corresponding increase in visits and reviews of the IPD by federal regulators. Consequently, we encourage the public to continue to post on the IPD.
Please do not ban menthol cigarettes. I have smoked for 39 years and tried to quit twice and could not stand the coughing and stress on my heart. Also my blood pressure rose 20-30 points.
There appears to be considerable interest regarding CRE’s background, please see http://www.thecre.com/tpsac/?p=1132
Given the very large public response to this post, CRE will analyze the comments and prepare a White Paper for transmittal to the FDA.
TPSAC and CTR have a lot on their agenda but eventually they are going to have to develop an algorithm for addressing the “reduced harm” provisions of the new tobacco statute. In doing so they will have to be mindful of the applicability of the Data Quality Act to the resultant proceedings. Smokeless tobacco and e-cigarettes will be two issues leading the parade.
OTTAWA — The lobby group representing Canada’s tobacco companies, convenience stores and customs officers has given the federal government a failing grade for weak efforts to crack down on black-market cigarettes.
The National Coalition Against Contraband Tobacco (NCACT) assigned the government an F overall for failing to make progress on contraband tobacco, downgrading them from a D on a report issued in last May.
“The Harper government’s response to this problem amounts to unfulfilled promises or activities that have more public relations value than real impact,” Gary Grant, a spokesperson for NCACT, said at a news conference on Parliament Hill Wednesday morning. “It’s a government that talks tough on crime, but doesn’t follow through, in this area at least.”
The Daily Caller
Here’s a word of advice to the Food and Drug Administration (FDA) regulators deciding this week whether or not to ban menthol cigarettes: Cool it. If the FDA sows this wind, I fear we will reap the whirlwind.
It was only last year that the agency prohibited the sale of all other flavored cigarettes, but would outlawing menthol be a good idea?
The FDA’s power to ban it goes back to the 2009 “Family Smoking Prevention and Tobacco Control Act” — the law giving the Food and Drug Administration (FDA) authority to regulate tobacco. That bill contained a provision barring all flavorings except menthol.
Questions Raised by the NCI Presentation to TPSAC: “What Menthol Smokers Report They Would Do If Menthol Cigarettes Were No Longer Sold”
Editors Note: Hopefully the very talented staff of NCI can shed additional light on the questions which follow. Recognizing, however, that they have a wide range of commitments, CRE, as a safeguard, is initiating its own in-depth review of this subject. This action is warranted because a number of press articles reported the following conclusions but without any caveats.
In a January 10, 2011 presentation to TPSAC, a representative of NCI concluded:
o “Behavioral intention is associated with actual behavior”
o ” 39% of menthol smokers say they would quit all tobacco use if menthol cigarettes were no longer sold”
In my October 23 letter I explained in detail how I am vehemently opposed to smoking and try my best to advise young people on the hazards of smoking.
Nonetheless, people have the right to smoke, and despite my rage and railing, youngsters continue to take up smoking. So, I’ve decided I’m not going to get an ulcer over it anymore, better to get a dividend check.
Editors Note: The term “substantial equivalence” is going to determine in large part the initial—and possibly— the ultimate regulatory regime for the tobacco industry. The term has its genesis in non-tobacco regulatory programs which have been the subject of CRE interventions for a number of years.
CRE will be making periodic posts regarding this important subject notwithstanding the longstanding American disdain for reviewing historical developments on pending topics.
For starters, the term substantial equivalence goes back to the work of Food and Agriculture Organization, the World Health Organization and subsequently OECD recommendations in 1991 dealing with genetically modified foods. The Congressional Research Service offers the following definition of “substantial equivalence”
New Surgeon General’s Report Blows FDA Tobacco Act Out of the Water; Shows that Anti-Smoking Groups Were Untruthful in Their Public Statements
A major conclusion of the report is that there is no evidence that reducing levels of specific tobacco smoke constituents will lead to a decrease in human disease.
Benzinga Staff Writer
In the report, Goldman writes “Today’s meeting revealed little incremental news. While there remains a potential headline risk as we head into the March 23 deadline of TPSAC’s recommendation, we still believe that a ban or any draconian measure on menthol by the FDA is highly unlikely. In addition, TPSAC also appears to be struggling to come up with any drastic recommendation, given the limited time, lack of finished research, and the risk of a large-scale contraband market. Following are key takeaways from today’s meeting.”
Whatever one thinks about a menthol ban, the attached report prepared by CRE makes it clear that:
l. Contraband cigarettes are a lot worse for smokers than legitimate cigarettes. For one contaminant alone, lead, contraband cigarettes have been found to contain more than ten times the level found in legal cigarettes.
2. The very negative health effects of a ban will be the burden of two groups; adolescents who purchase contraband cigarettes with no age check, and African American smokers, over 80% of which smoke menthol.
3. Non-smokers will suffer also because of increased crime and violence.
Editors Note: CRE will make periodic posts of statements having major regulatory implications made by TPSAC and meeting attendees.
TPSAC is on course to issue a report on March 23, 2011 as required by statute.
TPSAC has asked Dr. David Mendez to develop a model to assess impacts of menthol on initiation/cessation. The author claims the model results are comparable with published results. The basis for this conclusion was not obvious from the presentation.
The fact that TPSAC is sponsoring a model to generate additional information on initiation/cessation suggests that the committee agrees with the thrust of the CRE DQA petition that the existing initiation/cessation studies are not ready for prime time.
A Nod Towards Regulating Tobacco Products Similar to a Medical Device: The Significance of the Menthol Review
Editors Note: We aplogize for not responding to the many emails we receive. But our readers must understand we have a very select audience of experts in science, law, public affairs and politics. Consequently any response requires a very well reasoned response, not necessarily in length but in content. The following post is made in response to inquiries regarding a likely regulatory scenario for tobacco regulation by the FDA. Nonetheless we encourage you to continue to express your opinions either by posting on this website or sending us an email through the link provided to the right of this article under “Important Sites”.
CRE has reviewed the studies commissioned by FDA on menthol. CRE’s review focuses on initiation/cessation studies.
1. Only one study investigated the association between smoking initiation and use of menthol cigarettes . This was a secondary analysis of the American Legacy Longitudinal Tobacco Use Reduction Study (ALLTURS), a large longitudinal school-based survey of middle school and high school youth conducted in three waves from 2000 through 2003. In this study, subjects were aged 12 to 17 at baseline. It found that starting smoking with menthol (initiating first to menthol) is associated with each of the six indicators of smoking initiation in this study. However, this relationship was not adjusted for well known confounders including race, family income, and parents/caregivers’ education and smoking status.
FDA has commissioned a number of studies of menthol based upon secondary analyses, meaning that the survey had been completed in past years and the data is then reexamined by researchers, often against study objectives that do not match the intent of the original survey. For example, in the studies by Okuyemi (2003 and 2007), National Survey data was re-categorized into menthol and non-menthol sub-groups which became disproportional and not adequate for computing statistics.
CRE is not alone in this conclusion in that authors of one of the FDA commissioned studies state:
A member of a key tobacco-advisory committee for the Food and Drug Administration who came under industry criticism has stepped down.
Gregory N. Connolly, a Harvard School of Public Health professor, no longer is listed on the agency’s website as a member of the panel. He didn’t respond to requests for comment.
In an email, FDA spokesman Jeff Ventura said: “Dr. Connolly has resigned from the Tobacco Products Scientific Advisory Committee. His departure will not impede the schedule or progress of the Committee.”
The FDA’s website now says the 12-member committee has one vacancy.
Two Studies That TPSAC Should Review in Detail
In an effort to attempt to disgorge CRE conclusion that studies to date regarding the impact menthol has on smoking initiation/cessation proponents of a menthol ban are in a rush to publicize studies however meritorious.
Examples include the eleven reviews of the literature studies commissioned by the FDA, the midnight publication of a special edition of Addiction as well as the recent barrage of studies submitted to TPSAC and so posted as meeting materials for its January 10 and 11 meetings.