![]() 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. Reynolds Vapor Company’s Vuse Vibe menthol e-cigarette product.” FDA had denied Vuse Vibe menthol the day before, on January 24, 2023. According to the FDA’s Malist 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. RJR is not simply accepting these marketing denials. 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. 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. 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. This is the same logic that FDA used to deny marketing orders for the other menthol e-cigarettes. NYTS data also found Vuse to be the second most common brand youth e-cigarette users reported “usually” using. 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. 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. While FDA does not make its detailed analysis public for marketing denial orders, it summarized its thinking in the press release:Įxisting 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. This action follows FDA denials for RJR Vuse Ciro menthol and JTI Logic menthol e-cigarettes. FDA has continued to deny marketing authorization for menthol e-cigarettes with its Maannouncement that it had denied marketing authorization for two RJR Vuse Solo menthol cartridges.
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