On June 23, the FDA issued marketing denial orders to all JUUL e-cigarette products currently on the market. This includes JUUL devices as well as pods in both tobacco and menthol flavors with both 3% and 5% nicotine concentrations. This also marks the first time the FDA has issued a marketing denial order to a popular menthol-flavored e-cigarette product. While the FDA’s stated reasons for the denial order are that “the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health,” and “concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods,” many public health organizations are hailing the decision due to the outsize role that Juul played in creating the youth e-cigarette use epidemic. Juul has applied for a stay to the order and is likely to appeal the decision.
In other news regarding pre-market review, earlier in June, the FDA authorized the sale of NJOY Daily e-cigarette devices and tobacco-flavored e-liquid pods, while issuing marketing denial orders to several others. However, the FDA is also expecting to only have reviewed a little over half of all product applications by the end of 2022 and is expecting to not finish reviewing all the applications for the most popular e-cigarette products until June 2023. Read more from the Truth Initiative here.
See all of the FDA’s decisions on their page: Tobacco Product Marketing Orders.