June 10, 2022
On June 10, the FDA issued decisions on multiple NJOY Daily e-cigarette products, including the authorization of two new tobacco products through the Premarket Tobacco Product Application (PMTA) pathway. The FDA issued marketing granted orders to NJOY LLC for its tobacco-flavored Daily disposable e-cigarettes – NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.
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 Daily e-cigarette products. Any of those products that remain 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 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. 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 aerosol harmful and potentially harmful constituents (HPHCs) from the new products compared to cigarettes. Additionally, estimates of complete 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 (ENDS). 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.
Importantly, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, including 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 cigarette 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 their marketing.
As shown in the 2021 National Youth Tobacco Survey (NYTS), among youth who currently used e-cigarettes, the most commonly used e-cigarette device type was disposables. The agency takes these data very seriously and strongly considered risks to youth when reviewing the applications for these products. Although the NYTS showed the relative popularity of disposable ENDS among youth, it also indicated that the most commonly used flavor types among youth who currently used any type of e-cigarettes were flavors such as fruit, candy or mint, and not tobacco flavors. These data informed the FDA’s decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for current adult smokers who completely switch to ENDS or significantly reduce their cigarette consumption.
Moreover, 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 granted order 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 marketing granted order letter and the “Executive Summary” section of the decision summary available to broadly explain the public health rationale for authorization of these products.