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

A proposed ban on menthol cigarettes has split the black community. Some argue in favor of banning the tobacco product most preferred by African Americans as a protection, others call it discrimination. Deron Snyder of The Root argues that banning some cigarettes and not others is paternalistic and not effective.

by Deron Snyder

Deron Snyder is a regular contributor to The Root.

Banning menthol cigarettes, which 80 percent of African-American smokers prefer, won’t make folks quit.

As with virtually every other African-American smoker I know, the only acceptable brands of cigarettes for me came in green-and-white packs. If you didn’t puff Salems — my cancer sticks of choice — you probably consumed Newports or Kools.

As CRE has stated repeatedly in its statements before the TPSAC, the hard science, toxicological studies dealing with acute and chronic effects of menthol,   suggests that such studies are not an area of concern.

Two issues will determine an objective evaluation of the menthol issue, “soft” science dealing with initiation/cessation and contraband considerations.

 CRE has reviewed more that fifty percent of the studies identified by FDA and conclude that either in total, or in part, they are not compliant with the Data Quality Act and therefore can not be used by the FDA.

CRE has reviewed another study described at http://www.thecre.com/scur/?p=331

Thursday, October 14, 2010

For the past eight years, I have been warning the tobacco control community about a gradual but steady decline in the scientific rigor of the movement. During the first three of those years, my warnings were internal and expressed through tobacco control list-serves, discussion groups, and other internal communications. For the past five years, I have written about this issue on The Rest of the Story.

CRE has benefited from the comments of a  number of experts in administrative law who have reviewed the ASA v. HHS decision of the Ninth Circuit. Based upon these reviews CRE concludes:

1.   That the Ninth Circuit decision parallels the recent Prime Time decision in that the  Ninth  Circuit  has invoked the DQA in reaching a judicial decision.

 2.  The judicial precedents  established by both decisions support an inference that  the DQA is judicially reviewable.

 3.   The fact that two divergent Circuit Courts have arrived at nearly identical  conclusions, albeit for different reasons, suggests that if the DC  Circuit were to opine directly on whether the DQA is reviewable,  it would do so in the positive.

We welcome your views in the “comments” section at the end of this post.

See the decision of the Ninth Circuit on medical marijuana at http://www.thecre.com/quality/2010/20101014_regweek.html

Did the court rule against medical marijuana but in doing so did it reinforce the conclusions of the DC Circuit in Prime Time that the DQA guidelines are binding on agencies?

The court referred to the OMB DQA guidelines when stating that the process in the Controlled Substances Act governed the proceeding;  it did not refer to the  CSA as the governing statute.

 A crucial health issue that has not been addressed by the TPSAC is how a ban on menthol cigarettes would harm public health.  By statute, the FDA is supposed to examine how a menthol ban or other cigarette standard would impact the health adult tobacco users.  While the FDA has briefed the TPSAC with low-quality, unreliable and ultimately unusable studies on the purported/hypothesized effects of menthol on smoking initiation and cessation, they ignore the health harm from counterfeit cigarettes that would take the place legitimate menthol products.

Two highly influential stakeholders,  The National Black Chamber of  Commerce and the National Troopers  Coalition emphasize the negative  impacts of a menthol ban.

 Please see:

  http://www.thecre.com/tpsacnews/?p=233

 http://www.thecre.com/tpsacnews/?p=229

In order that our readers be informed of the major policy issues discussed at the TPAC meeting, we have posted  the articles below, dated October 7,  for your review.

We welcome your comments by posting on any or all of the posts.

NCI stated that a review of industry correspondence was very useful. Some TPSAC members disagreed with this assertion stating that there was no check on the credentials of the sources, Other TPSAC members stated that industry data is of limited utility when compared with information obtained from experts in the field.

 Editors Note:  CRE is not aware of any other FDA proceeding which allows the introduction of hearsay as a  credible source of scientific information.

Dr. Samet, TPSAC Chair, reminded his colleagues that  “we are the Tobacco Products  Scientific  Advisory  Committee NOT the Tobacco Products  Policy  Advisory Committee.”