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

Editors Note: 

There appears to be considerable interest regarding  CRE’s background, please see  http://www.thecre.com/tpsac/?p=1132

Given the very large public response to this post, CRE will analyze the comments and prepare a White Paper for transmittal to the FDA.

TPSAC and CTR have a lot on their agenda but eventually they are going to have to develop an algorithm for addressing the “reduced harm” provisions of the new tobacco statute.  In doing so they will have to be mindful of the applicability of the Data Quality Act to the resultant proceedings.  Smokeless tobacco and e-cigarettes will be two issues leading the parade.

By Dr. Gilbert Ross

The Daily Caller

Editors Note: Hopefully the very talented staff of NCI can shed additional light on the questions which follow.   Recognizing, however, that they have a wide range of commitments, CRE, as a safeguard, is initiating its own in-depth review of this subject. This action is warranted because a number of press articles reported the following  conclusions but without any caveats.

 In a January 10, 2011 presentation to TPSAC, a representative of NCI concluded:

   o   “Behavioral intention is associated with actual behavior”

   o     ” 39% of menthol smokers say they would quit all tobacco use if menthol cigarettes were no longer sold”

Ideas from Forbes Investor Team

 Nonetheless, people have the right to smoke, and despite my rage and railing, youngsters continue to take up smoking. So, I’ve decided I’m not going to get an ulcer over it anymore, better to get a dividend check.

Editors Note:  The term “substantial equivalence” is going to determine in large part the initial—and possibly— the ultimate regulatory regime for the tobacco industry.  The term has its genesis in non-tobacco regulatory programs which have  been the subject of CRE interventions for a number of years.

 CRE will be making periodic posts regarding this important subject notwithstanding the  longstanding  American disdain for  reviewing historical developments on pending topics.

 For starters, the term substantial equivalence goes back to the work of Food and Agriculture Organization, the World Health Organization and subsequently  OECD recommendations in 1991 dealing with genetically modified foods.  The Congressional Research Service offers the following definition of “substantial equivalence”

A major conclusion of the report is that there is no evidence that reducing levels of specific tobacco smoke constituents will lead to a decrease in human disease.

In the report, Goldman writes “Today’s meeting revealed little incremental news. While there remains a potential headline risk as we head into the March 23 deadline of TPSAC’s recommendation, we still believe that a ban or any draconian measure on menthol by the FDA is highly unlikely. In addition, TPSAC also appears to be struggling to come up with any drastic recommendation, given the limited time, lack of finished research, and the risk of a large-scale contraband market. Following are key takeaways from today’s meeting.”

Whatever one thinks about a menthol ban, the attached report prepared by CRE makes it clear that:

l. Contraband cigarettes are a lot worse for smokers than legitimate cigarettes. For one contaminant alone, lead, contraband cigarettes have been found to contain more than ten times the level found in legal cigarettes.

2. The very negative health effects of a ban will be the burden of two groups; adolescents who purchase contraband cigarettes with no age check, and African American smokers, over 80% of which smoke menthol.

3. Non-smokers will suffer also because of increased crime and violence.

Editors  Note:  CRE will  make periodic  posts of  statements  having major regulatory implications made by TPSAC and meeting attendees.

TPSAC is on course to issue a report on March 23, 2011 as required by statute.

TPSAC has asked Dr. David Mendez to develop a model to assess impacts of menthol on initiation/cessation. The author claims the model results are comparable with published results.  The basis for this conclusion was not obvious from the presentation.

The fact that TPSAC is sponsoring  a model to generate additional information on initiation/cessation suggests that the committee agrees with the thrust of the CRE DQA petition that the existing initiation/cessation studies are not ready for prime time.

 Editors Note:  We aplogize for not  responding to the many emails we receive. But our readers must understand we have a very select audience of experts in science, law, public affairs and politics. Consequently any response requires a very well  reasoned response, not necessarily in length but in content.  The following post is made in response to inquiries regarding a likely regulatory scenario for tobacco  regulation by the FDA.  Nonetheless we encourage you to continue to express your opinions either by posting on this website or sending us an email through the link provided to the right of this article under “Important Sites”.

 CRE has reviewed the studies commissioned by FDA on menthol. CRE’s review focuses on initiation/cessation studies.

 Major conclusions:

1.  Only one study investigated the association between smoking initiation and use of   menthol cigarettes .  This was a secondary analysis of the American Legacy Longitudinal Tobacco Use Reduction Study (ALLTURS), a large longitudinal school-based survey of middle school and high school youth conducted in three waves from 2000 through 2003. In this study, subjects were aged 12 to 17 at baseline. It found that starting smoking with menthol (initiating first to menthol) is associated with each of the six indicators of smoking initiation in this study. However, this relationship was not adjusted for well known confounders including race, family income, and parents/caregivers’ education and smoking status.

 FDA has commissioned a number of studies of menthol based upon secondary analyses, meaning that the survey had been completed in past years and the data is then reexamined by researchers, often against study objectives that do not match the intent of the original survey.  For example, in the studies by Okuyemi (2003 and 2007), National Survey data was re-categorized into menthol and non-menthol sub-groups which became disproportional and not adequate for computing statistics.

CRE is not alone in this conclusion in that authors of one of the FDA commissioned studies state:

Two Studies That TPSAC Should Review in Detail

In an effort to attempt to disgorge CRE conclusion that studies to date regarding the impact menthol has on smoking initiation/cessation proponents of a menthol ban are in a rush to publicize studies however meritorious.

Examples include the eleven reviews of the literature studies commissioned by the FDA, the midnight publication of a special edition of Addiction as well as the recent barrage of studies submitted to TPSAC and so posted as meeting materials for its January 10 and 11 meetings.

OTTAWA — The federal government’s intention to launch updated, larger and more graphic health warnings on cigarette packs is being applauded by anti-smoking and health advocates. But one tobacco company is questioning whether Thursday’s announcement evades a bigger problem — the sale of contraband cigarettes.

“Health Canada is ignoring the real tobacco problem in Canada today, and has decided to put further regulations on a legal industry that is already operating with a ton of regulations,” said Eric Gagnon, a spokesman for Imperial Tobacco.