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

Jun 26, 2010

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   http://www.thecre.com/scur/wp-content/uploads/2010/04/Hersey-f2.pdf

 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 comments are in the  attachments:

Attached Files:

 

One Response so far
  1. CRE
    June 26th, 2010 at 8:03 pm #

    See this post for comments received on the homepage.

    http://www.thecre.com/tpsac/?p=349

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