NJOY won approval today (April 26 2022) from the FDA on the NJOY Ace vape pod device system as well as 3 refill pods. The "classic tobacco" flavor in 2.4% and 5% strengths and "Rich Tobacco" in 5% strength.

Blueberry and Watermelon flavors were both rejected, which was expected by most observers of the approval process and political landscape surrounding flavors.

The FDA delayed making a decision on NJOY Menthol pods, which will continue on in legal limbo. Sales of the pods will continue until the FDA finalizes a ban on menthol flavor, which is expected this year.

From the FDA's marketing decision on the NJOY Ace:

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 their marketing.

What is interesting about the approval decision today is the fact that NJOY uses salt nic (tobacco free nicotine) in formulation of their vape juice. It seems that tobacco flavored pods are fine, synthetic nicotine or traditional plant extracted nicotine, assuming the FDA approves the paperwork.

Previously in April, the FDA had rejected similar pod formulations from BLU (Fontem US - Imperial Brands) leading one to believe the rejection may have been the result of an insufficient research submission failure on the part of the manufacturer after the similarly flavored NJOY pods gained approval.

The NJOY Ace, first entering the market after 2018, is the only device to gain approval so far that hasn't used outdated technology. The FDA indicated NJOY cleared the regulatory hurdles regarding "research" surrounding chemical testing of potentially harmful constituents of vapor when compared to cigarette smoke and didn't believe the product appealed to "young people".

NJOY enjoys just a small fraction of the U.S. market, under 5% market share, but is still considered to be the third largest vapor brand, trailing JUUL (Philip Morris) and VUSE (Reynolds).

The FDA has yet to decide the fate of several JUUL and VUSE market applications.