SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) on April 26 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%.
The move allows the products to be legally marketed in the United States; however, it does not mean the products are safe or FDA approved, the agency said.
The FDA also denied multiple Ace e-cigarette products from the Scottsdale, Ariz.-based company. Any of those products currently on the market must be removed from or risk FDA enforcement. The FDA did not name these products, and it advised retailers to contact NJOY with any questions about products in their inventory.
Applications for two menthol-flavored Ace e-liquid pods remain under FDA review. The FDA has made similar decisions with other vapor products that it has authorized under the premarket tobacco product application (PMTA) review process.
R.J. Reynolds Vapor Co.’s Vuse Solo closed electronic nicotine delivery system (ENDS) and accompanying tobacco-flavored e-liquid pods were authorized in 2021 by the FDA, but menthol-flavored products under the brand remain in limbo. ENDS products form Logic Technology Development LLC were also authorized under the Logic Vapeleaf, Logic Power and Logic Pro brands, but its menthol products remain under 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. NJOY's authorized Ace products have the potential to benefit adult smokers who switch completely, or significantly reduce their cigarette consumption, the FDA said. The FDA also determined the potential benefit to adult smokers who switch would outweigh the risk to youth.
The agency will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any requirements.
In addition to NJOY Ace e-cigarettes, which can be refilled with pods, the company sells NJOY Daily disposable e-cigarettes in Menthol and Rich Tobacco. PMTAs for NJOY Daily are still under review. The company stopped selling fruit-flavored e-cigarettes in early 2020.
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