Tobacco

Biden Grants FDA Authority Over Synthetic Nicotine

President signs Consolidated Appropriations Act
Capitol building
Photograph: Shutterstock

WASHINGTON — The U.S. Food and Drug Administration will have authority over tobacco products containing synthetic nicotine after two changes take effect in the next month.

President Joe Biden signed H.R. 2471, or the Consolidated Appropriations Act 2022, into law on March 15. The act provides funding through Sept. 30 for projects and activities of the federal government. It also included a provision that would change the Federal Food, Drug and Cosmetic Act’s definition of a tobacco product to “any product made or derived from tobacco or containing nicotine from any source, that is intended for human consumption.”

It also amends another section of the Federal Food, Drug and Cosmetic Act to include the following statement: “This chapter shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco,” according to the Consolidated Appropriations Act.

The move will help the FDA regulate tobacco products containing synthetic nicotine. Outgoing FDA Center for Tobacco Products (CTP) Director Mitch Zeller has called out Puff Bar as an example of a company trying to evade the FDA through a loophole that didn’t give FDA explicit authority over tobacco products made with synthetic nicotine. The FDA warned Puff Bar in early 2020 for selling fruity, disposable e-cigarette products that the agency said appealed to youths. However, the company got around FDA regulation by releasing products that instead use synthetic nicotine, Zeller said.

The amendments are effective 30 days after the enactment of the act, which would land on April 14.

Manufacturers marketing a tobacco product with synthetic nicotine would need to file a premarket tobacco product application (PMTA) with the FDA by May 14, or 30 days after the act becomes effective, to remain on the market.

Then they could sell their product for an additional 90 days after the effective date. After that time, though, the product would need to be removed from the market if the FDA has not issued an order granting the marketing of the tobacco product.

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