Seductive additive boosting addiction or harmless flavoring? ACSH examines the evidence on and complexities regarding menthol as an ingredient in tobacco products, an ingredient whose banning is often debated.

ACSH thanks the following experts for reviewing this publication:

Scott Ballin, J.D.Coalition on Smoking and Health

William T. Godshall, M.P.H. SmokeFree Pennsylvania

Gio Gori, Ph.D.Health Policy Center

Geoffrey Kabat, Ph.D., M.S. Yeshiva University

Peter N. Lee P N Lee Statistics and Computing, Ltd.

Carl Phillips, M.P.P., Ph.D. Tobacco Harm Reduction Institute

Brad Rodu, D.D.S. University of Louisville

20100421_Menthol_Statement_ACSH_2010.pdf (425 KB)

CRE is providing the attached advanced copy of the FR notice on harmful constituents to assist the public in participating in TPSAC meeting of June 9

Draft guidance also attached

FR Notice  here

FDA Harmful Consitutent Guidance

J Daniel Heck

Cigarette smoking is established as a substantial contributor to risks for cancer, cardiovascular and respiratorydiseases. Less is known about the potential of cigarette composition to affect smoking risks. The use of cigarette flavoring ingredients such as menthol is currently of worldwide public health and regulatory interest. The unique conditions of menthol inhalation exposure that occur coincident with that of the complex cigarette smoke aerosol require specialized studies to support an assessment of its safety in cigarette flavoring applications. The present state of knowledge is sufficient to support an assessment of the safety of the use of menthol in cigarettes. Scientific, smoking behavioral and epidemiological data available through mid-2009 is critically reviewed and a broad convergence of findings supports a judgment that menthol employed as a cigarette tobacco flavoring ingredient does not meaningfully affect the inherent toxicity of cigarette smoke or the human risks that attend smoking. There remains a need for well-designed studies of the potential of menthol to affect smoking initiation, cessation and addiction in order to differentiate any independent effects of menthol in cigarettes from those imposed by socioeconomic, environmental and peer influences on these complex human behaviors.

The FDA has issued two documents lisitng menthol studies of interest.

The controlling document,  which in the absence of a direct charge to the tobacco advisory, is a statement by the Center for Tobacco Products.

The other document is a bibliography of  controlling documents prepared by NCI.

Eventually CRE will subject some of the studies in the above referenced documents to tests to determine whether or not they comply with the Data Quality Act.

To assist CRE in these  important evaluations,  stakeholders should present relevant documents in the comments section below or in the post capability to  right of this post.

The Center for Tobacco Products briefed US Senate. View their presentation.