WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) has published a notice in the Federal Register announcing a 60-day extension of the comment period for the Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes. Specifically, the FDA is requesting information to inform its thinking about potential regulatory options, such as establishing tobacco product standards, sale and distribution restrictions, and other regulatory actions and considerations.

In a press release asking for comments, the agency said that in the United States, about 30% of all adult smokers and more than 40 percent of all youth smokers report smoking menthol cigarettes. “Menthol cigarettes raise critical public health questions,” said FDA Commissioner Margaret A. Hamburg. “The FDA is committed to a science-based approach that addresses the public health issues raised by menthol cigarettes, and public input will help us make more informed decisions about how best to tackle this important issue moving forward.”

In late August, NACS expressed its concern about “the adverse impact of overly restrictive federal regulations on menthol cigarettes, including a possible prohibition on manufacture or sale. A ban on menthol in cigarettes risks giving rise to an entire industry of unregulated cigarette products that would create significant health concerns.”

The majority of that concern focuses on question C3, which states: “If menthol cigarettes could no longer be legally sold, is there evidence that illicit trade in menthol cigarettes would become a significant problem? If so what would be the impact of any such illicit trade on public health? How would any such illicit trade compare to the existing illicit trade in cigarettes?”

NACS pointed out that “there is ample evidence … that illicit trade in menthol cigarettes would become a significant problem if the FDA outlaws menthol cigarettes. It is simply not reasonable to expect that the menthol market, which accounts for roughly 30% of cigarette sales today, will vanish overnight or could be phased out over time if menthol cigarettes are banned. Combined with the relative ease of obtaining menthol flavorings, black market manufacturers will sprout up or expand quickly.”

Also troubling is the fact that the agency only asked broad questions about illicit trade “instead of developing a fact-based foundation to understand the current extent of illicit trade as Congress intended, and then seeking comment from interested parties on those findings. … It is impossible to assume that a menthol ban will reduce underage smoking, which is the announced objective of, and justification for, virtually every provision of the Tobacco Control Act. If anything, a ban on menthol will aggravate underage smoking problems, as demonstrated by the Canadian experience. Unlike legitimate retailers who take seriously their responsibility to curb tobacco sales to underage youth, the purveyors of illicit menthol cigarettes, operating outside of the law, will not discriminate among their customers based on age.”