Bill Could Grant FDA Authority to Regulate Tobacco Products With Synthetic Nicotine

Legislation would amend definition of tobacco product: Briant
Photograph: Shutterstock

LAKEVILLE, Minn. — On Dec. 15, NATO News reported that a bill was introduced in Congress called the Clarifying Authority Over Nicotine Act of 2021, which would expand the FDA’s regulatory over tobacco products to include products that contain synthetic nicotine. This week Congress is considering legislation titled the Consolidated Appropriations Act of 2022, which would fund the U.S. government through September 2022. The U.S. Senate passed the act on March 10, and the bill is now being prepared for transmission to President Biden for his review and likely signature to enact the legislation.  

This new appropriations legislation includes a section that would grant the FDA authority to regulate tobacco products which contain nicotine that is not made or derived from tobacco (e.g., synthetic nicotine).

Specifically, the appropriations bill amends the definition of the term “tobacco product” under the Family Smoking Prevention and Tobacco Control Act to define a tobacco product as “any product made or derived from tobacco or containing nicotine from any source, that is intended for human consumption” (new language is italicized). In addition, the language of the section includes a new sentence that reads “This chapter shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco.”

The legislation states that the amendments regarding the definition of a tobacco product would have an effective date 30 days after the day that the bill is enacted. The legislation provides that a manufacturer marketing a tobacco product which contains nicotine from a source other than tobacco (e.g., synthetic nicotine) must file a premarket tobacco application (PMTA) with the FDA within 30 days after this effective date for the product to remain on the market. Then, for an additional 90 days after the effective date, the manufacturer can continue to sell its product on the market. At the time this 90-day period ends, 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.

For example, if the legislation is enacted on April 1, the effective date of the new definition of “tobacco product” would be May 1. A manufacturer would need to file a PMTA for its product which contains synthetic nicotine with the FDA by May 31. If a manufacturer files a PMTA, the manufacturer can continue to sell its tobacco product through July 30. If the FDA issues a PMTA marketing authorization order by July 30, then the manufacturer would be able to continue to sell its product after July 30; however, if the FDA has not issued an PMTA marketing authorization order for the tobacco product by July 30 or issues a PMTA marketing denial order, then the tobacco product can no longer be sold on the market after July 30 and the FDA can exercise its enforcement discretion to ensure the product is removed from the market.

Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at info@natocentral.org.

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