NCI Recognizes the Benefits of Medical Marijuana: DQA Implications

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.

Altria Responds to Menthol Cigarette Report

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.

Cigarette Counterfeiting, Problems and Thoughts on Countermeasures

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? 

Is that right? Menthol cigarettes are more dangerous?

  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.

FDA says tobacco law doesn’t apply to two smokeless lozenges

Star Scientific was surprised to find the FDA doesn’t consider its two dissolvable tobacco lozenges to be forms of smokeless tobacco and thus aren’t covered by the 2009 tobacco law. Anti-tobacco activists say the ruling is a loophole other manufacturers will try to exploit
By Andrew Zajac, Washington Bureau
Reporting from Washington—

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.

NCI Funded Study Concludes: FDA Wrong About Menthol Cigarettes, Group Says

Editors   Note: The study described  below  provides additional evidence which compels the FDA to react favorably to the  CRE  Data Quality Petition.
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: March 23, 2011

Cigarette Ban Would Slash State Revenues

By MERRILL GOOZNER, The Fiscal Times
March 20, 2011

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.

HHS Notifies CRE that they Anticipate a Response to our Data Quality Act Petition by May 19

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.

The TPSAC statement is consistent with the repeated statements CRE made before TPSAC.

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.

Menthol tobacco firm shares soar

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?”

FDA panel: Menthol cigarette ban good for public health

By Rita Rubin, USA TODAY

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.

Decision on menthol cigarette ban could come Friday (Washington Times)

Editors Comment:

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

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?”


Big tobacco fights FDA on menthol cigarette ban

Tobacco industry report says menthol cigarettes no riskier than regular cigarettes, but not all agree

CBS News/AP Wire

(AP) RICHMOND, Va. – Menthol cigarettes are no riskier than regular cigarettes and shouldn’t be regulated differently, the tobacco industry argues in a report to the Food and Drug Administration first obtained by The Associated Press.

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.

Menthol Cigarettes Marketed as ‘Healthier,’ FDA Panel Says

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  and so reported in FDA Week


By Jenifer Goodwin
HealthDay Reporter

US  News

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.

Strategies To Exploit Uncertainty in Tobacco

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).

Data Quality Issues Raised During the Public Comment Period on Substantial Equivalence

 Several respondents raised questions concerning the scope and utility of the data being requested by the FDA.

Altria states:

“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:

The 510(k) Process: A View of the Medical Device Industry

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).”

An Unanticipated Cosequence of Family Smoking Prevention and Tobacco Control Act (FSPTCA)?

By Robert A. Mellion
Posted Mar 10, 2011 @ 12:35 PM

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.

GAO on Illicit Tobacco: Part 1

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.”

How Should Society Deal With the Drug Nicotine?

Tony Newman

Director of Media Relations, Drug Policy Alliance

Posted: March 2, 2011 05:05 PM


“Have no illusions about this, my friends: the CRE is the USA’s regulators of the FDA!”

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 .

Draft Chapters Point to Relatively Benign Menthol Outcome

by Philip Gorham | 01 Mar 11 

Morning Star  Equity Analyst in Toronto Star

emphasis supplied

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.

FDA TPSAC’s Menthol Theater Closing Its Doors

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.

Lorillard Lights Up



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. 

FDA panel findings could lead to curbs on menthol cigarettes

By Andrew Zajac, Washington Bureau
Los Angeles Times

March 2, 2011

Reporting from Washington —
Menthol flavoring may make it easier to become addicted to cigarettes and may make smoking more alluring to young people, according to an FDA advisory panel’s preliminary report. Experts don’t expect the findings will lead to a ban on menthol, however


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.

US advisers mixed on menthol smokes, Lorillard up


* 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.

Menthol eases tobacco use, FDA panel finds

Bellinham Hearld

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.”

Menthol Not Shown to Raise Health Risks of Smoking, U.S. Draft Report Says

By Molly Peterson – Mar 1, 2011 12:01 AM ET

Smokers don’t face more risks of tobacco-related disease from menthol cigarettes than unflavored cigarettes, a U.S. advisory panel says in a preliminary report.


“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.