June 17, 2022

Bipartisan AG Coalition Calls for FDA Regulation of Non-Tobacco Nicotine Products

Bernard Nash

Cozen O'Connor

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Cozen O'Connor

A bipartisan coalition of AGs from 27 states, the District of Columbia, and three territories has called on the FDA to deny marketing authorization for non-tobacco nicotine products (NTNs) which are currently marketed without regulatory oversight.
On March 15, 2022, President Biden signed into law an amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) that extends the jurisdiction of the FDA to tobacco products that contain nicotine not derived from tobacco. Under the new legislation, manufacturers of NTNs that wish to market their products had to submit a premarket application by May 14, 2022 and receive FDA authorization by July 13, or be subject to FDA enforcement action.
In a letter to the FDA Commissioner, the coalition argues that these products cannot satisfy the “public health” standard of Section 910 of the FDCA, and therefore no authorization should be given for NTNs unless and until that standard can be met. Should the FDA not deny marketing authorization to all NTNs, the coalition urged denial to flavored NTN products, and regulation with respect to marketing, surveillance, and reporting requirements, as well as restriction of claims referring to the absence of tobacco.

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