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U.S. Department of Health and Human Services

For Industry

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What are the penalties if a cigarette package or advertisement is found out of compliance?

Cigarette packages and advertisements that do not comply with the rule violate the Federal Cigarette Labeling and Advertising Act (FCLAA).  In addition, cigarettes are misbranded under the FD&C Act if their packages and advertisements do not comply with the rule.  Therefore, failure to comply with the final rule may lead to FDA actions including civil money penalties, seizure, injunction, or no tobacco sale orders, among other things.

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