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06/13/2022

FDA Grants PMTA Approval to Additional NJOY Products

The agency is still reviewing applications for two menthol-flavored NJOY Daily e-cigarettes.
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SILVER SPRING, Md. — More NJOY vapor products are staying on the market.

The Food and Drug Administration (FDA) issued marketing granted orders for premarket tobacco applications (PMTAs) for two NJOY LLC tobacco-flavored Daily disposable electronic cigarettes. The authorization covers NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%. 

The agency's decision allows the products to be legally marketed in the United States. While this action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they "FDA approved," according to the agency.

The FDA also issued marketing denial orders to NJOY for multiple other Daily e-cigarette products. Any of those products that remain on the market must be removed, or the agency may take enforcement action, it cited.

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, that marketing of the new tobacco product would be appropriate for the protection of the public health, according to the FDA.

The authorized NJOY products were found to meet this standard because, among several key considerations, the overall toxicological risk to the users of the new products is lower compared to combusted cigarette smoke due to significant reductions in harmful aerosol and potentially harmful constituents from the new products compared to cigarettes.

Additionally, estimates of completely switching from cigarettes to the new products for current adult smokers was at a level higher than what is typically seen in the literature for estimates of complete switching to electronic nicotine delivery systems.

Therefore, the applicant has demonstrated that some current adult smokers are interested in the new products to assist in decreasing or quitting their cigarette use, and these products have the potential to benefit that group, the agency said.

In April, the FDA authorized four NJOY Ace e-cigarette products via its PMTA pathway. The marketing granted orders covered NJOY Ace Device; NJOY Ace Pod Classic Tobacco 2.4%; NJOY Ace Pod Classic Tobacco 5%; and NJOY Ace Pod Rich Tobacco 5%.

The NJOY decisions come as the FDA is working toward finishing its review of the millions of PMTAs manufacturers submitted for vapor products by the Sept. 9, 2020 deadline — a majority of which the agency denied.

In October, the FDA authorized R.J. Reynolds Vapor Co.'s Vuse Solo electronic nicotine delivery system to remain on the market. The decision was the first time the agency authorized a vapor product for the U.S. market — and it came more than a year after the PMTA deadline for vapor products.

Since then, however, the agency has been slow to make decisions on PMTAs submitted by major vapor brands. However, activity has ticked up in the past two months. In the timeframe, the FDA issued favorable marketing orders for Logic and NJOY products but issued marketing denial orders to Fontem US LLC for several myblu products.

And most recently, it gave the greenlight for certain Vuse Ciro and Vuse Vibe products to remain on the market.