US FDA enforcement: an analysis of the warning letters issued in 2024

In 2024, one of the top enforcement priorities for the US Food and Drug Administration (FDA) remained the removal of unauthorised tobacco products from the market, with a particular focus on e-cigarettes. These products received significantly more warning letters than any other tobacco category. Since 2020, the agency has emphasised enforcement against unauthorised e-cigarettes, as outlined in its industry guidance, and this approach has continued into 2024.

This report examines the US Food and Drug Administration (FDA) enforcement measures taken in relation to unauthorised tobacco products, and analyses the warning letters sent out throughout 2024.

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