On April 26, 2022, the U.S. Food and Drug Administration (FDA) authorized an additional four tobacco-flavored electronic nicotine delivery system (ENDS) products for marketing under the Premarket Tobacco Product Application (PMTA) pathway. Marketing granted orders (MGOs)^[1] were issued for the following NJOY tobacco-flavored ENDS products:

• NJOY Ace Device: Closed e-cigarette device

• NJOY Ace Pod Classic Tobacco 2.4%: Closed e-liquid cartridge (double pack)

• NJO Ace Pod Classic Tobacco 5%: Closed e-liquid cartridge (double pack)

• NJOY Ace Pod Rich Tobacco 5%: Closed e-liquid cartridge (double pack)

NJOY, one of the first companies to introduce e-cigarettes to the U.S. market in 2007, is now the first ENDS company to receive a PMTA MGO for a pod-based ENDS. NJOY is also the first company that is independent of the tobacco industry to receive an MGO.

Although FDA does not “approve” tobacco products, the MGO means that FDA has found that the tobacco-flavored NJOY Ace products meet the rigorous “appropriate for the protection of the public health” (APPH) standard set forth in the Tobacco Control Act. In making this determination, FDA cited to, among other things, data demonstrating that the overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of the products were lower than HPHC levels in the smoke from combustible cigarettes. NJOY also provided data demonstrating that users of the authorized products had lower levels of exposure to HPHCs compared to users of both the authorized products and combustible cigarettes. FDA suggested that these products, therefore, have the potential to benefit adult smokers by significantly reducing or altogether eliminating their consumption of combustible cigarettes. FDA also determined that this potential benefit to adult smokers outweighed the potential risk of youth initiation, provided that NJOY follows post-marketing requirements to reduce youth access and exposure to their marketing.

Several other NJOY Ace products, including fruit-flavored cartridges, were issued marketing denial orders (MDOs) and must be removed from the market immediately or be subject to enforcement action. Two NJOY applications for menthol-flavored Ace pods are still under review, and are likely to remain under review for now, given FDA’s recent proposal of a national ban on menthol cigarettes. According to former Center for Tobacco Products Director Mitch Zeller, to date, FDA has refused or denied premarket applications for over 99% of non-tobacco and non-menthol flavored ENDS.

Prior to the NJOY authorizations, FDA had only issued MGOs for the Vuse Solo system from the R.J. Reynold Vapor Company, as well as the Logic Vapeleaf, Logic Pro, and Logic Power systems from Logic Technology Development LLC, which combined account for less than 1% of the U.S. c-store market. In comparison, NJOY is the third-largest vape manufacturer in the U.S., accounting for a little over 3% of the market, after the popular JUUL system (by Juul Labs, accounting for around 38% of the market) and the Vuse Alto system (by the R.J. Reynold Vapor Company, accounting for around 30% of the market).

As discussed previously, FDA had signaled that it would begin to issue decisions on PMTA applications for popular ENDS products that account for a large share of the market and, therefore, have a greater potential to impact public health. On April 15, the District Court for the District of Maryland issued an order that FDA provide status reports on its progress on outstanding PMTAs, so we can expect this process to be accelerated.

ENDNOTES

[1] See marketing granted orders issued to NJOY LLC, available at: https://www.fda.gov/media/157958/download.