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

The topic for this meeting is  the impact of menthol on the prevalence of cigarette smoking and population health effects. Although the main focus is presentation and discussion of publicly available industry documents that pertain to menthol cigarettes, the meeting ;materials  also include FDA and CDC presentations of their views on what, if anything, can be concluded from the published scientific literature on certain menthol issues, an update on the work of the Menthol Report Subcommittee, and an opportunity for public comment.

The presentations on what has been gleaned from review of publicly available industry documents have been prepared by personnel from the University of California, San Francisco.

The agency presentations, and some of the UCSF presentations, are referred to as “white papers,” and they largely summarize the scientific publications presented by FDA and discussed at the March TPSAC meeting.  In previous meetings, FDA had indicated that it was in the process of preparing “white papers” on the menthol issues.  It is not clear whether the relatively brief summaries in these “white papers” are those that were referred to previously, or whether more detailed papers will be presented later.

Apparently in response to the recent CRE Information Quality Act petition, the webpage for the briefing materials for the meeting now displays a “DISCLAIMER” stating that “The findings and conclusions in these reports have not been formally disseminated by FDA and should not be construed to represent any agency determination or policy.”  Most of the agency presentations on individual issues also contain a header on the first page stating that they have not yet been peer-reviewed.  CRE notes that although these disclaimers represent progress, they do not conform to the wording of the disclaimer required by the OMB peer review guidelines (70 Fed. Reg. 2664, Jan. 14, 2005), principally in not referencing the need to comply with the Data  Quality Act.

Because CRE believes that the principal scientific issues remaining at this time concern the potential impacts of menthol on smoking initiation and cessation, we have so far only conducted a  review of the FDA presentations on only those issues. On the subject of smoking initiation, the agency acknowledges the paucity of scientific data, and (tentatively) concludes that that there are no data on whether menthol influences the “the trajectory from initiating cigarette use to regular smoking.” On cessation, the agency simply summarizes the various studies and notes that they are inconsistent and have significant limitations. On the whole, these agency “white papers” appear to be more balanced than the March slide presentations critiqued in the CRE DQA petition, especially in terms of refraining from placing undue emphasis on certain dubious findings from particular studies, although they still contain some of the DQA defects that CRE has previously detailed in its petition.   

 The UCSF presentations on what it found concerning menthol issues in the publicly available industry documents of the legacy collection appear to contain little that can be considered useful.  From millions of pages of industry documents, it found few that pertained to menthol.  Most of the documents are quite old — many from the 1970s — and, as acknowledged by the UCSF authors, they are mostly anecdotal and involve small samples or focus groups of menthol smokers (rather than comparing menthol smokers with non-menthol smokers).  In essence, the documents are non-scientific, and simply show that the industry was grappling with why some smokers preferred menthol cigarettes and why certain brands were gaining or losing market share.  There does not appear to be any evidence of “targeting” of certain types of smokers or attempts to hide information on health effects.