The Food and Drug Administration announced Friday that it has authorized the marketing of four menthol-flavored e-cigarette products from NJOY.
They are the first non-tobacco flavored e-cigarette products to receive such an approval, the agency noted in a statement, while emphasizing that the authorization only applies to these specific products and does not mean they are safe or “FDA-approved.”
The FDA said it had reviewed evidence submitted by NJOY, which apparently indicated that the products’ potential upside — helping adult cigarette smokers switch “to a less harmful product” — outweighs its risk of youth appeal.
“It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome,” Brian King, director of the FDA’s Center for Tobacco Products, said in a statement. “This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”
The FDA emphasized that it placed “stringent marketing restrictions” on the newly approved products and would closely monitor their marketing to prevent youth exposure, and could suspend or withdraw authorization if there is a marked increase of usage among youth or former smokers, or a decrease in the number of current smokers who switch.
Overall, the FDA says it has authorized 27 tobacco- and menthol-flavored e-cigarette products and devices, including the four newly authorized ones.
According to the Wall Street Journal, Altria’s NJOY is the number-three vaping brand in the U.S., behind Vuse and Juul, comprising about 3% of e-cigarette sales. Altria divested from Juul and bought NJOY Holdings for at least $2.75 billion last year.
Earlier this year, the Biden administration delayed a proposal to ban menthol-flavored regular cigarettes.
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