Abstract

In the United States, the Food and Drug Administration (FDA) requires tobacco product manufacturers to submit Premarket Tobacco Product Applications (PMTA) for new products, granting marketing approval only if deemed appropriate for the protection of public health. Historically, the tobacco industry has exploited loopholes in the Tobacco Control Act (TCA), especially related to the definitions of nicotine, tobacco product and characterizing flavors, to circumvent the PMTA requirement. In 2023, the industry introduced several 'PMTA-exempt' e-cigarette and smokeless products, including products containing 6-methyl nicotine, a synthetic nicotine analog that is pharmacologically more potent than nicotine. In late 2023 and early 2024, the major US e-cigarette suppliers Nicotine River and ECBlend introduced 'PMTA-exempt' products with the brand names 'Nixamide' or 'Nixodine' or 'Nixotine', with nicotinamide as the main active ingredient. Nicotinamide is a form of vitamin B3 with no known pharmacological activity at nicotinic receptors. Here, we report that the marketing claims for these products, suggesting them and be nicotine substitute products designed to target nicotinic receptors and provide the same experience as nicotine, is deceptive and misleading to consumers. We also inform that these products have evolved further to contain a combination of nicotinamide and 6-methyl nicotine. The regulatory implications of these newly introduced products are discussed.

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call

Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.