Sunday, December 22, 2024

Regulating nicotine is a cat and mouse game

 Attempts to regulate (and tax) cigarettes and related nicotine-addicting products are a cat and mouse game. Many laws regulate "tobacco," "nicotine," or "flavorings," and all of these have close substitutes that might fall outside of the law, such as synthetic (non-tobacco) nicotines, and coolants other than menthol that might not be considered flavorings.  California legislators are amending laws to fill those gaps.

California’s Visionary Tobacco Bill—Will the FDA Follow?  by Sven E. Jordt, PhD1,2; Sairam V. Jabba, DVM, PhD, JAMA, 2024

"The state of California has been a consistent leader in tobacco control, with one of the lowest smoking rates in the nation. On September 28, 2024, Gavin Newsom, governor of California, signed Assembly Bill 3218, which will further strengthen tobacco control in the state.1 The signed legislation will close 2 loopholes left open by California’s 2022 legislation that restricts sales of most flavored tobacco products, including menthol cigarettes and youth-appealing flavored e-cigarettes. The tobacco industry immediately exploited these loopholes to continue selling flavored tobacco products in the state. Similar loopholes remain in the legislation of other states and in federal regulations. Are other states and the US Food and Drug Administration (FDA) set to follow California’s example, or will California’s advance result in an even wider divide in tobacco control in the US?

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"The tobacco industry argued that California’s flavor ban does not apply to non-menthol cigarettes because the cooling sensations imparted by odorless cooling agents do not represent a banned “characterizing flavor,” meaning a distinguishable taste, aroma, or both. However, current scientific definitions of the term flavor, also adopted by the flavor chemical industry, include the entire range of sensations perceived during product consumption, including physical traits such as cooling sensations.4 In California’s new bill, legislators adopted this definition, clarifying the term characterizing flavor to include “a cooling sensation distinguishable by an ordinary consumer during the consumption of a tobacco product.”

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"The second loophole addressed by California’s new bill pertains to emerging e-cigarette products in which nicotine is replaced with chemical analogues such as 6-methyl nicotine.5,6 In both state and federal regulatory statutes, a tobacco product is narrowly defined as being derived from tobacco or nicotine. Manufacturers claim that this definition does not apply to products containing 6-methyl nicotine, because its chemical formula differs from that of nicotine. Manufacturers advertise that FDA review of their products is not required, flavor bans do not apply, and that the products are exempt from tobacco taxes, offering them in youth-appealing flavors such as rainbow fruit, blue razz ice, or strawberry apple lemon.5,6 California’s new legislation closes this loophole by extending the legal definition of nicotine, adding “and includes nicotinic alkaloids and nicotine analogs.”

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