FDA inches ahead by denying marketing order for RJR Vuse Solo menthol

FDA has continued to deny marketing authorization for menthol e-cigarettes with its March 17, 2023 announcement that it had denied marketing authorization for two RJR Vuse Solo menthol cartridges. This action follows FDA denials for RJR Vuse Ciro menthol and JTI Logic menthol e-cigarettes.

While FDA does not make its detailed analysis public for marketing denial orders, it summarized its thinking in the press release:

Existing evidence, including data from the 2022 National Youth Tobacco Survey (NYTS), shows that non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use. In contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk. Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote complete switching or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes. NYTS data also found Vuse to be the second most common brand youth e-cigarette users reported “usually” using.

This is the same logic that FDA used to deny marketing orders for the other menthol e-cigarettes. Since this argument applies broadly and it also likely to apply to all menthol e-cigarettes, especially since overall e-cigarettes as consumer products do not help adults stop smoking cigarettes. As it almost did under President Trump, FDA should protect public health now by applying its enforcement discretion to take all menthol (and remaining flavored) e-cigarettes off the market unless or until FDA made a positive decision on their pending applications to allow their marketing.

In particular, FDA still has not acted on any flavors of Vuse Alto e-cigarettes, the most popular of the Vuse product line with kids.

RJR is not simply accepting these marketing denials. According to the FDA’s March 17, 2023 list of marketing denial orders, “On January 25, 2023, the United States Court of Appeals for the Fifth Circuit granted a temporary administrative stay of the MDO issued to R.J. Reynolds Vapor Company’s Vuse Vibe menthol e-cigarette product.” FDA had denied Vuse Vibe menthol the day before, on January 24, 2023.

The next business day, March 20, 2023, RJR got a court order allowing Vuse Solo menthol to stay on the market while it appeals FDA’s order.

While moving in the right direction with these denials, the FDA’s continuing slow pace combined with the industry’s ongoing litigation that further shows things down, reinforces the importance of communities and states moving forward with comprehensive bans on the sale of all flavored tobacco products, including “non-menthol” flavor (which is, after all, also a flavor). Those policies are protecting the public right now and have already survived industry challenges all the way to the Supreme Court.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

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