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U.S. Department of Health and Human Services

Tobacco Products

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Cigarette Health Warnings: What Small Businesses Need to Know

As part of the Tobacco Control Act, Congress mandated that FDA require new health warnings on all cigarette packaging and advertising. Each new warning label features a color graphic, health warning statement, and telephone number for smoking cessation support. On June 21, 2011, FDA issued the regulation that will require such warnings.

The rule imposes different requirements and compliance dates based on whether you are a tobacco product manufacturer, retailer, importer, or distributor. Here is a general overview of the regulation:

  • After September 22, 2012*, no person may manufacture for sale or distribution within the United States any cigarette package that does not comply with the rule.
  • For cigarette packages manufactured prior to September 22, 2012*, manufacturers may continue to distribute the packages for an additional 30 days after the rule goes into effect.
  • On October 22, 2012*, manufacturers will no longer be allowed to introduce into the domestic commerce of the United States any cigarette packages that do not display the new graphic health warnings.
  • After September 22, 2012*, no manufacturer, importer, distributor, or retailer may advertise cigarettes within the United States if the advertisement does not comply with the rule.

 

A retailer is not in violation of the rule with respect to cigarette packages as long as the package:

  • contains a health warning,
  • is supplied by a license- or permit-holding tobacco product manufacturer, importer, or distributor, and
  • is not altered by the retailer in a way that is material to the requirements of section 4(a) of FCLAA or the rule.

 

Similarly, a retailer will not be considered in violation of the rule for publicly displayed advertisements as long as the advertisement:

  • contains a health warning,
  • is not created by or on behalf of the retailer (and the retailer is not otherwise responsible for including the required warning), and
  • is not altered by the retailer in a way that is material to the requirements of section 4(b) or 4(c) of FCLAA or the rule.

 

In cases where a cigarette package or advertisement violates the rule but the retailer is exempt, the manufacturer, importer, or distributor that provided the non-compliant package or advertisement would be liable for violating the rule.

 

Additional Resources

 

Please visit the Small Business Assistance webpage regularly for updated information on complying with cigarette health warnings requirements.

 

 

 

*The implementation date is uncertain, due to ongoing proceedings in the case of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration, No. 11-1482 (D.D.C.), on appeal, No. 11-5332 (D.C. Cir.).