A Public Participation Forum for the FDA Center for Tobacco Products and its Federal Advisory Committee (TPSAC)

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.

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 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?”

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Editors  Note:  Obviously TPSAC can spend its limited resources in the manner it sees fit such as historical and outdated marketing  scenarios; CRE believes it more significant that TPSAC address the shortcomings in the initation/cessation studies as addressed in the CRE Data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
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.

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.

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:

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, 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).”

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.”