The FDA clearly believes Logic’s menthol vaping products-and perhaps all menthol vaping products-pose more risk than 22nd Century’s combustible cigarettes. 22nd Century Group’s VLN Menthol King cigarettes are currently being sold with FDA’s okay under both PMTA and modified risk (MRTP) pathways. It’s worth remembering that one menthol product has been authorized by the FDA. The illegal market will grow even more quickly if FDA cuts off a legal path for menthol vaping products. They will continue using those products too, while the FDA pursues its goal of eliminating legal vaping, locked into the belief that its “authority” has some effect on the market. The FDA ignores the fact that a majority of youth vapers use unauthorized, gray market disposable vapes, available in all kinds of flavors, many of them mentholated. Additionally, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk of youth uptake.” “Recent data from the 2022 National Youth Tobacco Survey found most (84.9%) youth who used e-cigarettes in the past 30 days used non-tobacco-flavored e-cigarettes, and of them, 26.6% used menthol-flavored e-cigarettes. “For non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, existing evidence demonstrates a known and substantial risk with regard to youth appeal, uptake and use,” says today’s FDA press release. The regulator cites 2022 National Youth Tobacco Survey data as evidence. Today the agency seems to have decided that the “unique considerations” have been settled, and that menthol poses the same “risks to youth” that other flavors do. “The scientific review of menthol ENDS, as compared to other non-tobacco-flavored ENDS products, raises unique considerations,” said the FDA’s Aug. When announcing its first denials of flavored vape products in August 2021, the FDA took pains to separate menthol from other flavors. They have made great progress and I know they will use the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.The FDA says Logic did not provide enough evidence in its PMTAs to prove “that these menthol-flavored e-cigarettes are more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers.” “The balance of these issues was considered by the agency’s career scientists when evaluating the potential marketing of e-cigarette products. “We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine,” said FDA Commissioner Robert M. The data also showed that the products produce fewer or lower levels of some toxins, like carbon monoxide, than combustible cigarettes and the products’ abuse liability, or their ability to encourage continued tobacco use, addiction or dependence, was lower than that of combusted cigarettes. Most study subjects decreased the number of combusted cigarettes they smoked each day by greater than 80 percent, from an average of 13-16 cigarettes per day at screening to 1-2 by day 59. Specifically, available data showed that current tobacco users who used these tobacco-flavored products were more likely to significantly decrease their use of combusted cigarettes and that those who don’t smoke are unlikely to start using these products. The FDA’s review of the applications for the products authorized today determined that the marketing of the tobacco-flavored products and associated components is appropriate for the protection of the public health.
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