FDA-Track Responds to CRE Inquiry

 Editor’s Note

 “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.

CRE Inquiry

From: Jim Tozzi
Sent: Saturday, July 23, 2011 8:00 PM
Subject: April 4, 2011: FDA-TRACK CTP Quarterly Briefing Summary

FDA Officials:

The following is a statement from the aforementioned report.

Tobacco industry’s focus on contraband is a smokescreen: Montreal Gazette

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.


FDA’s Tobacco Committee Approves Revised Menthol Report

Convenience Store News


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.

Hennigfield’s Bluster

 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.

The Countervailing Effects of Counterfeit Cigarettes

  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

Federal Money Aims To Snuff Out Underage Smoking In Maine

By Rob Poindexter – July 11th 2011 08:21pm – Read more Local News

Augusta Federal money will soon be headed to Maine to help the fight against underage smoking. Statistics show that every day in America, around 3500 kids light up their first cigarette.

Summertime in DC

 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.

New label won’t stop people from smoking

   This file image provided by the U.S. Food and Drug Administration shows one of nine new warning labels cigarette makers will have to use by the fall of 2012. In the most significant change to U.S. cigarette packs in 25 years, the FDA's the new warning labels depict in graphic detail the negative health effects of tobacco use.
This file image provided by the U.S. Food and Drug Administration shows one of nine new warning labels cigarette makers will have to use by the fall of 2012. In the most significant change to U.S. cigarette packs in 25 years, the FDA’s the new warning labels depict in graphic detail the negative health effects of tobacco use.


What’s In A Picture?

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.

No more food pyramid.

Enlarge USDANo more food pyramid.

No more food pyramid.

USDANo more food pyramid.

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.

Government May Be Violating Tobacco Companies’ 1st Amendment Rights

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.

FDA cigarette study casts doubt on whether new warning labels would help smokers quit

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.