Report on Harm From Menthol Cigarettes Due This Year, FDA Says


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.

Cut through the smoke on FDA regulations

East Peoria  Times Courrier


Peoria, Ill. —

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 Daily Deluge


 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 Urges FDA: Shut Door on ‘Tobacco Candy’


From KTVZ.COM News Sources
WASHINGTON — A group of senators, led by Jeff Merkley of Oregon and Sherrod Brown of Ohio, called on the Food and Drug Administration’s Center for Tobacco Products on Monday to reverse a recent decision that could potentially open the door to the possible sale of tobacco candy – addictive and dangerous dissolvable tobacco products. 

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). 

Up Next at the Center for Tobacco Products

Decision deadlines near FDA schedule
By Linda Abu-Shalback Zid

CSP Daily News

ROCKVILLE, Md. — Following the release of an annotated version of the Tobacco Products Scientific Advisory Committee’s (TPSAC’s) report on menthol, the next few weeks will be a flurry of activity for the FDA Center for Tobacco Products (CTP), notably with a conclusion expected today about which new warning messages and images will be required for cigarette packaging.

Also this week–90 days after the March 23rd deadline of the TPSAC report–the CTP is slated to update the industry on its progress regarding its review of the science surrounding menthol cigarettes. According to the CTP website, “The FDA recognizes the strong interest in this issue among all stakeholders and will continue to communicate the steps the FDA is taking as it determines what future regulatory actions, if any, are warranted.”

Dates to watch include:

Warning Labels by June 22
The FDA issued a proposed rule to modify the required warnings that appear on cigarette packages and in cigarette advertisements. The warnings include nine new text warning statements accompanied by color graphics depicting the negative health consequences of smoking.

The Family Smoking Prevention and Tobacco Control Act requires the FDA to issue final color graphics by Wednesday. It also specifies that the requirement for the new health warnings on cigarette packages and advertisements will take effect 15 months after issuance of the final rule. The nine textual statements are:

  • WARNING: Cigarettes are addictive.
  • WARNING: Tobacco smoke can harm your children.
  • WARNING: Cigarettes cause fatal lung disease.
  • WARNING: Cigarettes cause cancer.
  • WARNING: Cigarettes cause strokes and heart disease.
  • WARNING: Smoking during pregnancy can harm your baby.
  • WARNING: Smoking can kill you.
  • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
  • WARNING: Quitting smoking now greatly reduces serious risks to your health.
Compliance Training June 28
At 1 p.m. eastern time, June 28, the CTP will host a webinar to provide retailers with FDA compliance training information on “Smokeless Tobacco Product Packaging and Advertising Requirements.” Click here for more information.

Menthol Discussion July 21
In the morning, TPSAC will discuss proposed editorial changes to its menthol report and consider additional oral and written comments from the public. “The committee will consider and deliberate on proposed changes to the report and adopt amendments that constitute the advice of the committee,” according to CTP website.

Dissolvable Tobacco July 21-22.
In the afternoon these dates, TPSAC will initiate discussions on dissolvable tobacco products. The discussions will begin the process for TPSAC’s required report to the Secretary of Health and Human Services “regarding the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children,” according to the CTP website. “The final report should take under consideration (1) the risks and benefits to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products.”

Developing nations hit at tobacco pack plan

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.

Illegal-smokes trade flourishing


South China Morning Post

One poor suburb has seen a big rise this year in gangs selling cut-price cigarettes, customs officials say

Clifford Lo
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.

FDA Committee Sets Sights on Dissolvable Tobacco, Menthol

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.

FDA Updates Menthol Report Changes

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.”

Democrats Against Science: Commentary Magazine

Alana Goodman 06.07.2011 – 10:41 AM

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:

FDA official: GOP amendment could gut preventative food-safety effort: The Hill

By Julian Pecquet – 06/07/11 10:53 AM ET     The Hill


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.

The Overwhelming Adverse Health Effects of Contraband Cigarettes


 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

PR Newswire: news distribution, targeting and monitoring

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.

‘One in four is smoking illegally’

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.

FDA Week on the Rehberg Amendment

‘Hard Science’ Approps Amendment Stemmed From Antibiotic Concerns

Posted: June 2, 2011

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.

What is the Impact of the Rehberg Amendment on Tobacco Regulation? An Update

 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.”