US FDA enforcement: an analysis of the warning letters issued in 2023

One of the main Food and Drug Administration (FDA) enforcement priorities for 2023 was to remove unauthorised tobacco products from the market, specifically e-cigarettes, which received many more warning letters than any other tobacco product. Since 2020, the agency has prioritised enforcement against unauthorised e-cigarettes, as stipulated in the FDA guidance for industry. This has not changed in 2023, with the agency issuing the most warning letters to the manufacturers, retailers and distributors of disposable flavoured e-cigarettes.

This report examines FDA enforcement measures taken in relation to unauthorised tobacco products, and analyses the warning letters sent out throughout 2023.

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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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