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Review of unauthorized ENDS products shows extensive e-cigarette…

Review of unauthorized ENDS products shows extensive e-cigarette and e-liquid product lines among nearly 100 companies in the US

Le N, McMann TJ, Cui M, et al. Tobacco Product Marketing Orders and Online Marketing and Sale of Unauthorized ENDS Products. JAMA Intern Med. Published online September 5, 2023. doi:10.1001/jamainternmed.2023.3101
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2809103
“Ninety-nine companies had a publicly accessible product catalog or a list of ENDS on their websites. Thirty-four companies (34%) were selling unauthorized products subject to enforcement. A total of 3961 distinct ENDS products (4809 including nicotine volume variants) were identified as potentially unauthorized and subject to enforcement, with a median of 65 products (range, 3-1455 products) per company.

Characteristics of unauthorized ENDS subject to enforcement are described…. Most (92.9%) products were e-liquids. Nearly half (40.5%) contained freebase nicotine, with 19.2% containing nicotine salt. The top 3 primary flavor categories were fruit (nonberry, tropical, or citrus), fruit (berry), and dessert. While 1055 ENDS products were labeled with cooling descriptors, less than one-third were explicitly labeled “menthol” or had descriptions mentioning menthol.

A recent independent report by the Reagan-Udall Foundation also concluded that enforcement of illegal ENDS that remain on the market needs prioritization, and that failure to remove products may be misconstrued as authorizing lawful marketing.”

Comment: Lack of marketing orders and enforcement by FDA enables unauthorized products to flood the market as if they are authorized for sale. A precautionary approach that bans the introduction of these products would have limited their availability and unauthorized use.

Stephen Hamann

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