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

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.

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

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.”

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.

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

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.

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.