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Issue link: https://read.dmtmag.com/i/166098
NATONEWS FDA Seeks Public Comments on Menthol Questions looking into use of menthol in cigarettes I n July, the U.S. Food and Drug Administration issued an "Advance Notice of Proposed Rulemaking" to seek additional information and comments from the public to make informed decisions about the use of menthol in cigarettes. In the notice, the FDA is seeking comments and additional evidence on three different topic areas including: (1) a tobacco product standard for menthol in cigarettes, (2) whether sale and distribution restrictions should be proposed on menthol cigarettes, and (3) the risk of a potential black market or illegal trade if the use of menthol in cigarettes is banned. The notice of rulemaking does not mean that the FDA has decided to issue proposed regulations about the use of menthol in cigarettes, but rather is an additional step the agency is taking to obtain public input on menthol before deciding whether or not to issue any proposed regulations on menthol cigarettes. The questions being asked by the FDA in each of the three topic areas are as follows: Thomas Briant is executive director of the National Association of Tobacco Outlets. NATO's toll-free number is (866) 869-8888 and the association's Web site address is www.natocentral.org. Tobacco Product Standard By seeking additional public comments, the FDA is attempting to determine whether a tobacco product standard for menthol in cigarettes should be adopted. The agency is seeking input on what would be a minimum and maximum allowable level of menthol in cigarettes for the protection of the public health. Also, besides a potential product standard for menthol cigarettes, the FDA is asking if the agency should consider issuing regulations to address menthol in other tobacco products besides cigarettes. And, if so, what other tobacco products with menthol should be regulated? If a product standard prohibiting or limiting menthol were to be established, the FDA wants to know what length of time should manufacturers be provided to achieve compliance with the standard. Furthermore, the agency is looking for feedback on whether an outright ban or gradual reduction in the amount of menthol used in cigarettes would be the best option for the protection of the public health. In addition, the FDA has asked the public if alternatives exist that could be substituted by manu- www.npnweb.com n NPN Magazine facturers to maintain the affect or appeal of menthol to menthol cigarette smokers and, if so, what are these substitutes? Then, the question raised by the FDA is whether these substitutes should be regulated as well. Sale and Distribution Restrictions In terms of seeking public comments on the sale and/or distribution of menthol cigarettes, the FDA is inquiring about what restrictions would be appropriate and what would be the impact on youth or adult smoking behavior, initiation, and cessation as a result of any restrictions? Specifically, the FDA is wondering whether it should establish restrictions on the advertising and promotion of menthol cigarettes? As has been the case with other tobacco-related regulations proscribed by the FDA regarding limitations on advertising, the agency would need to overcome the legal protections offered product advertising by the First Amendment to the U.S. Constitution. With the Constitution and the U.S. Supreme Court decisions protecting the right to advertise and promote legal products, any regulations considered by the FDA to limit or restrict advertising and promotion of menthol cigarettes would need to meet constitutional standards. Black Market/Illegal Trade The third area where the FDA is seeking comments involving the feasibility of implementing regulations on menthol cigarettes and the possibility of illegal trade. For example, the FDA asks if compliance with a menthol product standard is technically achievable. To that end, the agency also seeks input on whether there are other actions the FDA could take short of a new tobacco product standard on menthol that could better protect the public health. Moreover, the FDA is requesting evidence of an increase in black market activity or illicit trade if menthol cigarettes are regulated or prohibited and how significant the problem would be for public health purposes and the impact on law enforcement. The public has until September 23, 2013 to submit comments for the FDA's consideration. Comments can be submitted electronically to www.regulations. gov by typing FDA Docket Number "FDA-2013-N0521" in the "Search" box and following the prompts to complete and submit comments online. September 2013 11