On April 26, the FDA authorized four new NJOY Ace 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.
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 the 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.
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. 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. 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.
Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided that the company follows post-marketing requirements to reduce youth access and youth exposure to its marketing.
Additionally, this authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers — including youth — using these products.
The FDA may suspend or withdraw a marketing granted order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a notable increase in youth initiation.
Before making marketing decision documents available to the public, the FDA must redact trade secret and confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone. For these reasons, the full decision summary for marketing authorizations may not be posted to the Premarket Tobacco Product Marketing Granted Orders webpage until after the order issuance date. In the interim, to provide as much information as possible at the time of order issuance, the FDA is making redacted versions of the order letter and the “Executive Summary” section of the decision summary available to broadly explain the public health rationale for authorization of these products.