Will the FDA’s proposed ban on flavored tobacco products ever be implemented? | Blogs | Health law today

On April 28, 2022, the United States Food and Drug Administration (FDA) released two proposed rules that would ban menthol as a characteristic flavor in cigarettes and ban all characteristic flavors such as strawberry and menthol in cigars. The proposed rules were in response to efforts to reduce youth initiation and help current smokers quit, and are part of the FDA’s efforts to reduce tobacco-related health disparities.

The first rule proposed by the FDA (Menthol Product Standard) would prohibit the use of menthol as a characteristic flavor in cigarettes and cigarette components and parts, including those sold separately to consumers. Specifically, under the proposed rule, no one may manufacture, distribute, sell, or offer for distribution or sale a cigarette or cigarette component or part in the United States that does not conform to the standard. of menthol product. Regarding the purpose of this proposed rule, the FDA stated that “menthol’s flavor and sensory effects reduce cigarette harshness and allow new users, especially youth and young adults, to continue to experiment and progress towards regular use”. Additionally, the FDA stated that “data shows that menthol cigarettes contribute to greater nicotine addiction in youth and young adults than non-menthol cigarettes.”

The second rule proposed by the FDA (Flavored Cigar Product Standard) would prohibit the characterization of flavors (other than tobacco) in cigars and cigar components and parts. When finalized, the flavored cigar product standard would prohibit a person from manufacturing, distributing, selling, or offering for distribution or sale in the United States a cigar or any of its components or parts containing characteristic aromas. Under this proposed standard, a cigar or any of its components or parts may not contain “an artificial natural flavor (other than tobacco) or any herb or spice, including, but not limited to, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, coffee, mint or menthol which is a characteristic flavor of the tobacco product or tobacco smoke.

In a press release, the FDA said it would not prosecute individual consumers for possession or use of menthol cigarettes or flavored cigars once these rules are finalized. Instead, the FDA said it will focus on “manufacturers, distributors, wholesalers, importers, and retailers who manufacture, distribute, or sell such products in the United States that do not comply with the requirements. applicable”.

Flavored tobacco products have been on the market for a very long time. FDA regulations prohibiting the use of flavorings in cigarettes, cigars and their constituents are likely to face significant legal challenges. We will continue to monitor this situation to see what the future holds for flavored tobacco products.

Interested stakeholders may submit comments on the proposed rules until July 5, 2022 via these filings, File No. FDA-2021-N-1349 and File No. FDA-2021-N-1309.

Foley is here to help you deal with the short and long term impacts as a result of regulatory changes. We have the resources to help you navigate these important legal considerations related to business operations and industry-specific issues. Please contact the authors, your Foley relationship partner, or our healthcare practice group with any questions.

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