The FDA has requested comments on “Tobacco Product Advertising and Promotion to Youth and Racial and Ethnic Minority Populations.
In response to this request,
Mr. Zachary Ryan Morgan writes:
“The FDA has even been looking at banning flavored cigarettes, including menthols, but “Joshua Rising, a researcher for the FDA, found no casual link between smoking menthols and an earlier initiation of smoking.”
Roswell Cancer Center states:
“We find no evidence that those who self-report smoking a menthol cigarette brand have different quit rates than those who self-report smoking a non-menthol cigarette brand, after adjusting for other smoking and demographic factors.”
Where is the Beef?
CRE has a particular interest in studies dealing with an alleged relationship between menthol and smoking initiation and cessation. CRE has not examined the totality of the studies identified by the FDA. A partial review to date suggests that FDA should retract the list of studies submitted to TPSAC on the aforementioned subject areas and re-submit only those studies which meet FDA internal quality requirements.
CRE has analyzed one such study which serves as a fulcrum for FDA’s recommendations to TPSAC: ” Are Menthol Cigarettes a Starter Prodcut for Youth?” conducted by Hersey et al.
The researchers suggest that menthol cigarettes are a starter product that may be associated with smoking uptake by youth.
The public expects TPSAC to address the merits of the studies submitted to it by the FDA, some of which appear to over state the relationship between menthol and the initiation and cessation of smoking by youth.
CRE has reviewed the study by Hersey et al and has identified a number of shortcomings, which if stand after outside peer review, would deem it non-compliant with the DQA. CRE is requesting public comment for the material set forth therein.
CRE analysis available at http://www.thecre.com/scur/wp-content/uploads/2010/04/Hersey-f2.pdf
CRE has more problems with statements made by the proponents of a menthol ban than it does with statements made by the authors of the study. In other words CRE has identified several technical issues which might materially change or limit the conclusions of the study; the conclusions set forth in the study however are based on possible incorrect conlusions but in general are not an overstatement of the results as viewed by the auhtors of the study.
Proponents of a menthol ban, have in CRE’s view, greatly overreached on the conclusions reached in the Hersey et al. study. Fortunately the third-party provisions of the Data Quality Act prohibit the FDA from using the said material as a basis for rulemaking.
Editor’s Note We have no knowledge of the particular document Mr. Morgan refers to regarding conclusions reached by Dr. Rising. However, we have extracted statements Dr. Rising made at the March 30 TPSAC meeting in the Rising attachment below which appears to substantiate Mr. Morgan’s conclusion.
Full text of aforementioned comments are in the attachments: