Live From FDA Headquarters: TPSAC January 10-11 Meeting

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.

CRE suggests  that the  FDA review OMB’s information quality guidelines to insure that the FDA model is DQA compliant.

Technical reports prepared by RTI international for the FDA  Center for Tobacco Products provided the basis for the next presentation.  The documents reviewed were submitted by industry to FDA per the Agency’s request.  The public review is limited to non-confidential data.

Concluding statements: decline in youth smoking of  non-menthol cigarettes.   No hard data on menthol contribution to initiation/cessation was presented.  Another conclusion  was that there was considerably more switching from menthol to non-menthol, then from non-menthol to menthol.

14   studies were conducted regarding menthol contribution to  initiation/cessation.

6     studies showed no effect.

6     studies showed mixed results and

2      showed potential contributions to cessation.

The above results are commensurate with CRE reviews presented on this website under studies and reports.

Dr.  Henningfield made the observation that when there was an effect that it was in the direction of cessation; the presenter answered yes to this statement. However, if he had  answered the same questions in terms of outcomes, the overwhelming number of outcomes demonstrates that menthol does not contribute to cessation.

CRE made the following points in its testimony

1. The TPSAC study plan has a serious omission—they are spending no time on assessing the impacts of contraband on public health.

 2. The study of the health effects are in the TPSAC charter and that is the expertise of TPSAC.

 3. The health effects of contraband fall on two subpopulations:

 —  Adolescents—who will be able to purchase limitless amounts of cigarettes without an age check.

 — African- Americans, the overwhelming majority of which smoke menthol cigarettes.

CRE discuss ed the following health effects of contraband:

Toxic Metals

 Cadmium—2 to 6 times the level in legal cigarettes

Thallium—1.5 to 6 times the level in legal cigarettes

  Lead—3 to 14 times the level in legal cigarettes

Tar, Nicotine and Carbon Monoxide

Contraband has:

75% more tar than legal cigarettes

28 % more nicotine

63 % more carbon monoxide

Miscellaneous Contaminants

 UK reports counterfeit cigarettes have been found to contain rat droppings, camel dung, sawdust and tobacco beetles.

CRE submitted a report to TPSAC on contraband at

Impact on Non-Smokers

 —        increase in criminal activity

–         increase in gang violence

–         increase in police activities

A  statement mady by a representative by the Canadian Association of Convenience Stores gave real world examples of  the adverse effects of ban as spelled out by CRE.

Public Comments do matter.  The Chair raised a question as to how the comments made during the public comment would be addressed in the TPSAC report. Based upon discussions lead by the Chair, Chapter 7 of the TPSAC report dealing with public health impacts of menthol will address the impact of public health resulting from the sale of contraband cigarettes.

Report Assignments

Chapters 1 & 2   Introduction and Evidence       Jonathan Samet

Chapter 3            Physiological Effects               Neal Benowitz

Chapter  4           Patterns of Smoking                Patricia Nez Henderson

Chapter 5            Initiation, Cessation Mkg        Dorothy Hatsukami

Chapeter 6          Risk Factors                             Jonathon Samet

Chapter 7            Public Health Impact               Mark Clanton

A representative from the National Association of Attorney’s General stated that there are a number of ways to get around a menthol ban, including legal means such as selling small cigars with menthol in them.

The Chair brought up the issue of writing the report based upon a consensus .  The majority of TPSA was not in favor of allowing minority reports   but left open the possibility of including opposing views in the main report.

A question was raised at the TPSAC meeting regarding the origin of contraband cigarettes in Canada.  The issue is addressed in CRE’s report (p. 26) based on information published by the Royal Canadian Mounted Police (RCMP):

The RCMP’s May 2009 Progress Update also provides information on the changing nature of the contraband market. The Update prominently notes in red-bordered box on the Introduction page that “Historically the contraband tobacco environment was based primarily on the diversion of legally manufactured products; today it is driven largely by illegal manufacturing.”

 The source used by CRE was: Royal Canadian Mounted Police (2009) “Contraband Tobacco Enforcement Strategy – Progress Report May 2008-May 2009,” p. 6.

Finally, a mysterious presentation and an equally mysterious response from TPSAC.

 A representative from NCI  (Anne Hartman) described a survey the agency had just completed.  NCI asked a number of smokers what they would do if a menthol ban were implemented.

A substantial number of the respondents stated they would cease smoking.  NCI stated that it is a well known axiom of behavioral  science that respondent’s answers in such instances are consistent with their future activity.

Such a presumption appears to be at variance with first hand knowledge of a number of individuals not to mention a substantial variance from  established peer reviewed articles on the subject.

The TPSAC did not address the premise of the NCI study, but concluded that they should exercise care in adopting the attendant recommendations without peer review.

The discussion on Chapter 3 is aimed at addressing the sensory concerns of menthol.  In particular, it will examine the sensory effects of cooling and soothing. One member of the advisory board stated that although desensitizing is a major issue, there are a number of substances that have the same effect as menthol.  Therefore, this chapter must address any difference between menthol and these other substances.  The discussion on Chapter 5 seemed to take place in a vacuum.  Yesterday, the consultants hired by FDA to summarize studies on initiation/cessation reported that the majority of studies demonstrated no effect—see the paragraph above.  It is not clear why these studies are not discussed in the context of Chapter 5.

Chapter 7 is the controlling chapter because it is going to discuss the risks from removing menthol from the market—as the chapter editor stated, “Where the rubber hits the road.”   Dr. Clanton said the chapter would address the public health impacts of contraband.  Chapter 7 will also address population level effects.  Although chapter 7 will call on the content of all the previous chapters, it will not be a derivative chapter, in that it is going to introduce new analyses particularly analyses dealing with contraband.

Leave a Reply

Please Answer: *