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.”

Dr. Henningfield stated that if menthol were a new drug application, industry would have to demonstrate the benefits of menthol.  The Chair’s response  was that TPSAC is  to give views on science, FDA will handle the benefit considerations.  FDA, much to its credit, concurred.  

Dr. Connolly raised the possibility of incorporating the precautionary principal into the committee deliberations.

 Editors note: It appears the committee has a tendency to migrate from their statutory requirements to look at science — and only science–  into policy considerations.  The incorporation of the  precautionary principal into a scientific assessment would be a blatant violation of the Data Quality Act.

Dr. Clanton raised the possibility of the TPSAC issuing an interim report, given the large task before the committee.  Dr. Samet thinks that such a suggestion may be in order given the paucity of menthol-specific studies compared to those concerning direct smoking.

Dr. Clanton also raised the question of whether the strength of evidence used in clinical studies should not be used and instead a lower standard of evidence, i.e., “an association”– meaning a weak, statistically insignificant relationship between cause and purported effect.

Dr. Samet gave an excellent presentation on the strength of evidence to be used in determining causal relationships.  The importantace of Surgeon General’s 1964 Report was discussed but why was no mention made of of the controlling statutory requirement passed by the Congress in 2000—the Data Quality Act?

TPSAC is going to use Special Government Employees in the preparation of its report.  It is imperative that the FDA publish their names and professional background.

Dr. Connolly again asks for a six month extension for preparation of a report saying it was a herculean exercise.  There is no meaningful sanction which could be taken against FDA for granting the extension.

FDA implied that industry was not responsive to the data request from TPSAC.  However, upon questioning by members of a committee, it appears that industry submitted hundreds of pages of information.  CRE is perplexed by the negative tone of the FDA presentation. What is the FDA’s bottom line concern?

The topic for this meeting is  the impact of menthol on the prevalence of cigarette smoking and population health effects. Although the main focus is presentation and discussion of publicly available industry documents that pertain to menthol cigarettes, the meeting ;materials  also include FDA and CDC presentations of their views on what, if anything, can be concluded from the published scientific literature on certain menthol issues, an update on the work of the Menthol Report Subcommittee, and an opportunity for public comment.

The presentations on what has been gleaned from review of publicly available industry documents have been prepared by personnel from the University of California, San Francisco.

The FDA has released   material its October  meeting.

The FDA material references initiation and cessation studies. The overwhelming number of these studies were reviewed in detail by the  CRE DQA petition.

 Should not the CRE DQA petition be reviewed by TPSAC as part of its review of the studies identified by FDA?

Is the TPSAC going  to  submit  a  report  which complies with the DQA or is going to ignore the statute and send a report which the FDA can not use?

What is the role of the non-voting tobacco representatives in the preparation of the report?