FDA Briefing on Menthol Cigarettes
As our Troutman Sanders Tobacco Team reported in the December 2009 Edition of Smokeshop Magazine, under the Family Smoking Prevention and Tobacco Control Act (“Act”), cigarettes that contain certain flavors will be considered “adulterated” if such ingredients can be considered as a “characterizing flavor.” While examples of prohibited flavors are provided by the Act, (which include strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, and coffee), the phrase “characterizing flavor” is not specifically defined by the Act. Menthol flavor is, however, specifically exempted from this list of prohibited flavors by Section 907(a)(1)(A) of the Act. Notwithstanding such statutory exemption, Congress mandated that the Food and Drug Administration (FDA) establish a Tobacco Products Scientific Advisory Committee (“Committee”) and refer to the Committee the issue of the impact of menthol, especially use among children, African Americans, Hispanics and other racial and ethnic minorities. In this regard, the FDA held a two day meeting on October 7th and 8th to receive input from such various Advisory Committees on the perceived impact of menthol in cigarettes. These reports were based on various white papers as well as research and screening efforts of documents contained in the Legacy Tobacco Documents Library (LTDL). See generally, Briefing Information for the October 7-8 Meeting of the Tobacco Products Scientific Advisory Committee
Among the various comments and issues raised were:
- the perception that menthol cigarettes are safer choices;
- the study of menthol cigarette campaigns and consumer perceptions;
- the marketing of menthol cigarettes in publications whose target audiences are Black/African-Americans;
- the tobacco industry’s study of younger smokers preferring lower levels of menthol than experienced smokers; and
- the changes in menthol contents viewed as attempts by the industry to attract different types of smokers, especially those who are inexperienced.
The essence of a number of suggestions is that the tobacco industry, since the early 1980s, has been studying the effects of menthol and its potential uses beyond its role as a flavor-related ingredient, and the industry has extended its study to menthol’s role in the design of low nicotine delivery cigarettes. The FDA Scientific Advisory Committee appears to be concerned that manufacturers could design cigarettes with lower nicotine content, and yet still manipulate the levels of menthol, to provide the equivalent strength and impact that the higher nicotine level cigarettes delivered. Such manipulations would potentially undermine the impact of nicotine reductions--a result beyond simply adding a menthol flavor.
Where these studies may lead is certainly in question. Congress may become more involved in amending the Act to eliminate the current “menthol exemption;” however, Congress has already made clear that despite the exemption for menthol, the Secretary of HHS has authority to take such action as is necessary regarding menthol. See Sec 907 (e)(3) of the Act. We will provide updates as the developments on menthol issues unfold.