Jul 30

FDA Considering Rulemaking for Menthol Cigarettes

On July 23, 2013, the U.S. Food and Drug Administration (FDA) issued an Advanced Notice of Proposed Rulemaking (ANPRM) to request information regarding the agency’s regulation of menthol cigarettes. Menthol is a common flavoring additive used in tobacco products and is currently the only flavor permitted for use in cigarettes. The FDA is considering further regulation as a way to address certain public health risks that are raised by menthol cigarettes, particularly in comparison to regular cigarettes. You can read the ANPRM here.

The FDA has authority to regulate tobacco products pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009. The use of menthol in cigarettes, however, is currently exempt from restrictions applicable to other flavors in cigarettes. For example, menthol is an exception under Section 907(a)(1)(A) of the FDCA, which otherwise prohibits the marketing and sale of cigarettes that contain a characterizing flavor as a constituent or additive.

As the FDA explains, prospective regulatory options include establishing tobacco product standards, restricting the sale and distribution of menthol cigarettes, and any other appropriate actions. Particularly, the FDCA provides the FDA with authority to establish a tobacco product standard, amend an existing product standard, or restrict the sale and distribution of a tobacco product if it is appropriate for the protection of public health.

The agency will consider all comments, data, research, and other information submitted in response to the ANPRM, available for public comment until September 23, 2013, in making its decision. The FDA will also look to scientific studies, including its “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes,” which is provided for comment here. The preliminary evaluation is the FDA’s independent analysis of the association between menthol cigarettes and various outcomes including initiation, addiction, and cessation.

In sum, if the FDA does decide to issue a rule, the next step will be a Notice of Proposed Rulemaking. If you have any questions about the FDA’s regulation of tobacco products or the rulemaking process, please contact us at: contact@giannamore-law.com.

FDA Lawyer

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