FDA Issues Import Alert to 30 Vape Companies

Import Alert 98-06, published on 05/17/2023, states that the FDA can detain new tobacco products without physical examination if they lack required marketing authorization. The alert is based on the Family Smoking Prevention and Tobacco Control Act of 2009, which gives FDA authority to regulate tobacco products. The rule extending this authority to products such as e-cigarettes and cigars took effect on August 8, 2016.

Any "new tobacco product" not commercially marketed in the US as of February 15, 2007, or any modification of a tobacco product marketed after this date requires premarket review. Marketing authorization or FDA's order of substantial equivalence or exemption from such requirements is necessary for such a product.

Unauthorised new tobacco products are considered adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act respectively. Divisions can detain these products, listed on the Red List, without physical examination. Removal from this Red List requires sufficient demonstration that the violation has been addressed.

Requests for removal should be sent to the FDA's Division of Import Operations in Rockville, MD, or emailed to Importalerts2@fda.hhs.gov. Import-related questions should be directed to ORA/DIO, and questions about tobacco products to the Center for Tobacco Products, Office of Compliance.

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Reference: FDA Import Alert