Smokeless tobacco products without required warning label

Why FDA issued it

NOTE: The revision of this Import Alert, dated 03/09/2023, updates the guidance section on addition to and removal from DWPE (red list), the product description section, current Agency contact information, charge section, and PAF/ PAC codes. Changes are bracketed by asterisks (***). The Family Smoking Prevention and Tobacco Control Act provides FDA with authority to regulate tobacco products by recognizing FDA as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products. As of July 22, 2010 manufacturers cannot distribute any smokeless tobacco product unless its packaging complies with the warning requirements in accordance with the Food Drug and Cosmetic Act (FD&C Act) and the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), 15 USC 4402. Under section 3 of CSTHEA, the package of a smokeless tobacco product for

Quoted from the “Reason for Alert” section of the FDA page for 98-03, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.