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@sglawfl.com.

In the warning letters, the FDA explains that the companies are required to immediately correct the violations. Also, they have 15 working days from the date that they received the warning letters to submit a written response to the agency. The response must describe all corrective actions that the company has taken to bring their cigarette products and advertisements into compliance with the FDCA and accompanying FDA regulations, especially the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which gives the FDA jurisdiction over the manufacturing, distribution, and marketing of tobacco products.

In particular, after reviewing the companies’ websites, the FDA found that several cigarette products were adulterated under section 902(8) of the FDCA because they are were marketed as modified risk tobacco products without FDA approval. According to section 911(b)(2)(A), a product is considered a modified risk tobacco product if its labeling or advertising represents that the product contains a reduced level of a substance or uses the descriptors light, mild, or low. For example, certain cigarettes were labeled as containing reduced levels of tar and nicotine. A modified risk tobacco product cannot be marketed without an FDA order pursuant to section 911(g). Otherwise, it is adulterated in violation of the FDCA.

Additionally, the FDA notes that many of the cigarettes are either adulterated or misbranded because they are marketed as flavored cigarettes in violation of the FDCA as amended by the FSPTCA. Under section 907(a)(1)(A), a cigarette or any of its components shall not contain a natural or artificial flavor, other than tobacco or menthol, as a constituent or additive that is a characterizing flavor. Cigarettes marketed and sold in violation of this provision are considered adulterated.  Otherwise, if the cigarettes do not actually contain a characterizing flavor, they are misbranded as their labeling or advertising is false or misleading.

More information about the requirements for selling a modified risk tobacco product can be found here. If you have any questions about FDA regulations regarding the marketing of tobacco products or need a FDA attorney to help you respond properly to warning letters, please contact us at contact@sglawfl.com.