Abstract
ABSTRACTAs of April 14, 2022, the United States Food and Drug Administration (FDA) has been authorized to regulate tobacco products containing nicotine from any source, including synthetic, requiring manufacturers to submit a premarket tobacco product application (PMTA). A recent report by the World Health Organization (WHO) warned that non-nicotine tobacco alkaloids or other synthetic nicotine analogs could be used by manufacturers to bypass regulatory schemes focusing on nicotine alone. From October 2023 on, vape stores in the United States started selling a new electronic cigarette pod system, named Spree Bar, advertised as “PMTA exempt”, with youth-appealing flavors and advertising. The products are marketed as containing “Metatine”, a trademarked name for 6-methyl nicotine, a synthetic nicotine analog patented by a Chinese electronic cigarette manufacturer. Here we used liquid chromatography-mass spectrometry (LCMS) to confirm the presence of a chemical species with the molecular weight of 6-methyl nicotine in Spree Bar e-liquids. The FDA needs to determine whether, in its view, 6-methyl nicotine is a form of “nicotine” within the meaning of the Tobacco Control Act, or whether 6-methyl nicotine can be regulated as a drug under the Federal Food, Drug, and Cosmetic Act (FDCA).
Publisher
Cold Spring Harbor Laboratory
Reference21 articles.
1. Synthetic nicotine has arrived
2. Synthetic Nicotine: Science, Global Legal Landscape, and Regulatory Considerations;World Health Organ Tech Rep Ser,2023
3. USFDA. New Law Clarifies FDA Authority to Regulate Synthetic Nicotine: 2022. Available: https://www.fda.gov/tobacco-products/ctp-newsroom/new-law-clarifies-fda-authority-regulate-synthetic-nicotine [Accessed 10/08/2023].
4. Spree Bar: 2023. Available: https://web.archive.org/web/20231008033049/ https://spreebar.com/ [Accessed 10/08/2023].
5. Charlie’s Holding Inc.: 2023. Available: https://web.archive.org/web/20230923115401/ https://charliesholdings.com/ [Accessed 10/10/2023 2023].
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献