FDA Approves 4 NJOY Ace ENDS Products

The agency also denied PMTAs for other Ace e-cigarette products, which NJOY had already removed from the market.

April 27, 2022

NJOY ACE Products

ALEXANDRIA, Va.—The Food and Drug Administration (FDA) has 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, according to a news release.

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%

The FDA also issued marketing denial orders to NJOY for multiple other Ace e-cigarette products.

The NJOY e-cigarette products subject to marketing denial orders had already been withdrawn from the market pursuant to the FDA’s January 2020 guidance, a person close to NJOY shared with NACS Daily. The company’s premarket approval applications for two menthol-flavored Ace liquid e-pods are still undergoing FDA review as the agency noted in its April 26 release.

Under the PMTA pathway, the applicant must demonstrate to the FDA, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health.

“The authorized NJOY products were found to meet this standard because, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke,” wrote the FDA in the release.

“Further, data provided by the applicant demonstrated that participants who had used only the authorized NJOY Ace products had lower levels of exposure to HPHCs compared to the dual users of the new products and combusted cigarettes. Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption,” the agency said.