FDA Authorizes Disposable E-Cigarettes From NJOY

2 tobacco-flavored products receive marketing granted orders; others denied

SILVER SPRING, Md. — NJOY has the all-clear to sell its tobacco-flavored disposable e-cigarettes.

The U.S. Food and Drug Administration issued marketing granted orders under the premarket tobacco product application (PMTA) process for NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%. The designation does not mean the products are safe nor “FDA approved,” the agency said, but allows them to be legally marketed in the United States.

The FDA also issued marketing denial orders (MDOs) to NJOY for multiple other Daily e-cigarette products. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.

Under the PMTA pathway, the applicant must demonstrate to the agency, among other things, the marketing of the new tobacco product would be appropriate for the protection of public health. The authorized NJOY products met this standard because, among several reasons, the overall toxicological risk to the users of the new products is lower compared to combusted cigarette smoke, the FDA said.

Also, the potential benefit to adult cigarette smokers who switch outweigh the risk to youth that products pose, provided the company follows post-marketing requirements to reduce youth access and youth exposure to their marketing, the agency said. The FDA will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any requirements.

The FDA in April also authorized four NJOY Ace e-cigarette products: NJOY Ace Device, NJOY Ace Pod Classic Tobacco 2.4%, NJOY Ace Pod Classic Tobacco 5% and NJOY Ace Pod Rich Tobacco 5%.  

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