FDA Offers Retailers Guidance on Cigarette Warning Regulations

ROCKVILLE, MD -- The Food and Drug Administration has issued guidance to help small businesses understand and comply with recently issued regulations that require warnings on all cigarette packs and cigarette advertising. The new regulations take full effect in September 2012.

Under the new regulations, the required warning will consist of a warning statement and an accompanying graphic image. The required warning must occupy the top 50 percent of the front and back panels of cigarette packages, and it also must occupy 20 percent of the area of cigarette advertisements and appear at the top of the advertisement, according to the FDA. Roll-your-own tobacco and cigarette tobacco are not covered by this regulation.

All advertisements, regardless of form, must display the required warnings. Advertisements could include materials such as magazine and newspaper advertisements, pamphlets, leaflets, brochures, coupons, catalogues, retail or point-of-sale displays (including functional items such as clocks), posters, billboards, direct mailers and Internet advertising, the agency explained.

Violations of and the misbranding of cigarettes could lead to warning letters, criminal penalties, civil money penalties, injunction, seizure, and no-tobacco-sale orders. However, 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.

Similarly, a retailer will not be considered in violation of the rule if it displays an advertisement in a location open to the public that does not comply with all the requirements of the rule so 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.

The agency released proposed warnings last November and approved the nine final versions and graphic images in June. However, major cigarette manufacturers are fighting the warnings, arguing that they violate free speech. Both sides are waiting for U.S. District Judge Richard Leon to issue a ruling, which could come any day. At a hearing last month Leon said he hoped to have a ruling by the end of October.