FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind

November 17, 2021 by Alec Stone MA, MPA, Former ONS Director of Government Affairs and Advocacy

Under the authority given in the Family Smoking Prevention and Tobacco Control Act, in October 2021 the U.S. Food and Drug Administration (FDA) authorized (https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency) the marketing of three new electronic nicotine delivery system (ENDS) products, “marking the first set of ENDS products (https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency) ever to be authorized by FDA through the Premarket Tobacco Product Application pathway.” The agency made the announcement it continues its review of thousands of tobacco and e-cigarette products (https://voice.ons.org/advocacy/fda-issues-marketing-denial-orders-for-55000-flavored-e-cigarette-products)’ marketing applications.

The authorization granted marketing orders to R.J. Reynolds (RJR) Vapor Company after the company submitted data that demonstrated (https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency) that “marketing of the products is appropriate for the protection of public health.” It allows the products to be legally sold in the United States, according (https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency) to FDA.

RJR Vapor Company may now market its Vuse Solo closed ENDS device, the Vuse Solo Power Unit, and accompanying tobacco-flavored e-liquid pods, Vuse replacement cartridge original 4.8% G1 and Vuse replacement cartridge original 4.8% G2. According to FDA, the products met the standards for the marketing order because FDA “determined (https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency) that the potential benefit (https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency) to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, provided the applicant follows postmarketing requirements aimed at reducing youth exposure and access to the products.” FDA also reported (https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency) that it issued 10 marketing denial orders for non-tobacco–flavored ENDS products that RJR submitted under the Vuse Solo brand.

FDA’s Center for Tobacco Products Director Mitch Zeller, JD, said that the “manufacturer’s data demonstrates (https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency) the company’s tobacco-flavored products could benefit addicted adult smokers who switch to these products.

“We must remain vigilant with this authorization, and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth,” Zeller said (https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency). “We will take actions as appropriate, including withdrawing the authorization.”

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