In an effort that anti-smoking advocates are calling way overdue, the FDA is investigating the safety of menthol and other flavoring additives in tobacco products to determine if these additives should be more heavily restricted or even banned.

This investigation comes as e-cigarettes continue to gain overwhelming popularity amongst consumers. The FDA wants to determine whether these potential health risks necessitate readdressing the restrictions placed on e-cigarettes and other tobacco products containing flavoring additives. Earlier this week, Commissioner Scott Gottlieb, MD, announced that the FDA has issued an advanced notice of proposed rulemaking (ANPRM) – a process of collecting data and hearing expert testimony on the costs and benefits of tobacco flavoring additives to determine whether these products should be more heavily restricted or even banned. The FDA conducted an ANPRM to determine whether to ban methanol and other flavoring additives in 2013. To the detest of anti-smoking groups, no changes followed this ANPRM. The current ANPRM pertains to e-cigarettes and other non-combustible tobacco products. Flavor additives in combustible tobacco have been banned since 2009.

Almost all popular e-cigarettes contain some form of flavoring additive. Gottlieb noted that the intention of the flavoring additives in these products was obviously to appeal to the youth, middle-school and high-school students. Gottlieb said that he recognized the validity of the argument that these flavors help adult smokers to wean off of cigarettes. However, Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, disagreed with the validity of this claim. Myer explained that while there is an abundance of evidence that e-cigarette flavorings are associated with increased use among teens and young adults, there is almost no evidence that the flavoring will help cigarette smokers to quit.

If the FDA does decide to restrict or ban some or all tobacco flavoring additives, the agency will conduct a follow-up comment period. Robin Koval, president of Truth Initiative, said that in the best-case scenario, it will be several years before the restrictions or bans are put into effect. “The FDA is taking the right actions, so we are optimistic that they are serious about this,” Koval said. “But time is of the essence. This has taken way too long.”


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