Comments from the Docket: Menthol No Impact on Start or Quit Rates

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.

Under the Data [Information] Quality Act FDA is prohibited from using any information from a third-party, such as TPSAC, unless it meets the requirements of the Data Quality Act.

 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

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:

5 comments. Leave a Reply

  1. Anonymous

    If menthol does not impact initiation or cessation, study over, right?

  2. Anonymous

    Interesting that CRE quoted these two studies, are not there conflicting conclusions in the docket?

    Editors Note: The docket is open for nearly another month. Our purpose here is not to summarize all the comments but instead quote the “highly influential” comments; the FDA and the Roswell Reserach Center most definitely meet this requirement.

  3. An Additional Incentive for Quitting

    Dr. Glantz of the University of California (SF) states in his filing to the FDA:

    “In light of the recent consistent literature showing that distrust of the tobacco industry is associated
    with lower likelihood of smoking and increased quit attempts”

    Extracted from Glantz Submission FDA Docket 2009-N-0294

  4. Mildred S. Morse, Founding Direct, Tobacco Independence Campaign

    What scientfic study proved that menthol does or does NOT impact initiation or cessation? No study suggest that conclusions of “relationships between Menthol use and cessation rates (particularly among African Americans)” are based upon mere inconclusive anecdotal inferences.

    Re: anonymous wrong comment below: Study can not be “over” until its started!

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