On April 26, the FDA issued decisions on multiple NJOY Ace e-cigarette products, including the authorization of four new tobacco products through the Premarket Tobacco Product Application (PMTA) pathway.
The FDA issued marketing granted orders to NJOY LLC for its Ace closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods, specifically:
- NJOY Ace Device
- NJOY Ace Pod Classic Tobacco 2.4%
- NJOY Ace Pod Classic Tobacco 5%
- NJOY Ace Pod Rich Tobacco 5%
This authorization allows these products to be legally marketed in the U.S. 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.” All tobacco products are harmful and potentially addictive. Those who do not use tobacco products shouldn’t start.
The FDA also issued marketing denial orders to NJOY for multiple other Ace e-cigarette products. Any of those products currently on the market must be removed or FDA may take enforcement action. Retailers should contact NJOY with any questions about products in their inventory. Applications for two menthol-flavored Ace e-liquid pods remain under FDA review.
U.S. Food and Drug Administration – 2022-04-26