US: nicotine analogues – regulatory status at federal and state level

Last year, synthetic nicotine analogues appeared on the US market in vaping and oral products, marketed as exempt from the Food and Drug Administration (FDA)’s premarket tobacco product application (PMTA) requirements and other regulations. While some states have begun introducing bills addressing these products, the FDA has yet to take action.

While chemically similar to nicotine, synthetic substances are not subject to federal requirements and most of the state tobacco regulations, allowing manufacturers to sell e-cigarettes and alternative nicotine products that contain nicotine analogues without seeking FDA authorisation.

This report examines nicotine analogues and their regulation at both the federal and state level.

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Kristina Iashina

Junior legal analyst
Kristina holds a Masters Degree in International Law from Moscow State Linguistic University, Russia. In 2020 she completed a six-month exchange programme at the University of Malaga. She has worked as a legal secretary at the Ninth Arbitration Court of Appeal, Russia; and as a legal assistant in a law firm in Moscow.

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