February 10-11 2011 TPSAC Meeting

 TPSAC is making a deliberate effort to complete its first major undertaking; a report on menthol in cigarettes.

TPSAC is to be complimented for writing the report from scratch in lieu of marking up a draft prepared by FDA.

Much to its credit TPSAC has released a draft of the first two chapters of the report, available    here  .

TPSAC is conducting the review in an open and transparent method and has made every effort to accommodate public comments.

CRE encourages its readers to offer comments on these chapters on this post.

CRE will be reporting on major actions taken at the meeting

Key issues to be addressed:

Chaper 1

Page  3   Initiation/Cessation

“The availability of menthol cigarettes could have no significant effect on risk for disease outcomes, yet have a significant effect on increasing initiation or reducing the success of cessation. The resultant increase in the prevalence of smoking would represent a negative public health impact”.
Editors Note:  The reader is encouraged to examine the CRE review of key initation/cessation studies identified by FDA at this post  http://www.thecre.com/scur/?p=352
Page 4   Why no mention of the health effects of contraband cigarettes?
The draft report states:
 This report contains six additional chapters. They cover TPSAC’s approach to identifying and weighing the scientific evidence; the prevalence and patterns of smoking among the population as a whole and in subpopulations such as by race/ethnicity and gender; physiological responses to menthol and to menthol and nicotine; marketing of menthol cigarettes and the effects of marketing and menthol cigarettes versus nonmenthol cigarettes on initiation, dependence and cessation; and biomarkers of exposure and risks for health outcomes.”.


It was CRE understanding that Chapter 7 was to address the health effects of contraband. Our readers are encouraged to express their views on this important topic.

Page 4  Reference Materials

Suprisingly, this link for the January TPSAC meeting  January 10-11, 2011: TPSAC Meeting Background Materials is no longer working. CRE is the opinion that it contained relevant information on how TPSAC was to  address the contraband issue.

The Interactive Public Docket  has a considerable amount of information regarding the issue at hand; furthermore, and more importantly it contains the views of  a large number of the public that are not associated with either the professional health community or the tobacco industry, see for example http://www.thecre.com/tpsac/?p=1032 .

Within the spirt of the the Presidents Open Government Initiative CRE believes that this IPD should be included in the reference material since any member of the public is allowed to express there views on the site.

Chapter  2

Editors Note:  CRE comments are under development; readers are encouraged to post their views.

Compliance with the Data Quality Act

The chapter contains the definitions of numerous terms which may or may not be in agreement with the stautory definitions of such terms in the DQA and their binding regulations. See for example,




CRE testified at the meeting;  CRE focused on incomplete statements made by NCI at the January TPSAC meeting, see  http://www.thecre.com/tpsac/?p=1067

Select Statements Made at the Meeting

Dr. David Mendez- University of Michigan

Dr. Mendez spoke of the development of a model of the consequences for  smoker’s prevalence and disease risks.

The first question is why do we need a model given the large number of studies conducted on menthol?

However meritorious,  there is insufficient data on the construct of  the model to ascertain whether it is DQA compliant.

Furthermore there is no probability that the public can analyze the model to determine whether or not the results are reproducible.

Surprisingly, notwithstanding the fact that the model is in its infancy, TPSAC seemed anxious to use its output.

It appears that the model is focused on  mortality and morbidity associated with menthols use—an issue CRE believes has been resolved months ago—there is  no difference between  mortality and morbidity for menthol versus non-menthol cigarettes.


Battelle stated it is in the process of terminating its sponsorship of any  programs sponsored by the tobacco industry; focusing instead on government contracts.

Battelle  stated there is insufficient information to make a decision on menthol and recommended a very detailed and involved research program.

1 comment. Leave a Reply

  1. Anonymous

    I’m a menthol smoker and if you’re going to ban menthol, go ahead and ban cigarettes altogether.

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