On Sept. 5, Judge Indira Talwani, of the U.S. District Court for the District of Massachusetts, ordered the U.S. Food and Drug Administration (FDA) to issue a final rule requiring graphic health warnings on cigarette packs and advertising. Per the order, the agency has three weeks to provide the court with a plan for implementation and must provide the court with an expedited schedule for completing any outstanding studies, releasing a proposed rule, reviewing public comments and issuing a new final rule in accordance with the Tobacco Control Act by Sept. 26.

Talwani ruled in favor of a 2016 lawsuit filed by several public health and medical groups, contending that the FDA had "unreasonably delayed" and "unlawfully withheld" the final rule on graphic labels, which were originally mandated close to a decade ago.

The 2009 Family Smoking Prevention and Tobacco Control Act, which regulated cigarettes, called for graphic warnings covering the top half of the front and backs of cigarette packs and 20 percent of cigarette advertising. The FDA was originally given until June of 2011 to issue a final rule requiring the warnings. The agency met the initial deadline, but tobacco companies filed lawsuits and the graphic warnings were struck down in 2012. In March of 2013, the FDA stated that it planned to issue a new rule requiring graphic warnings, but the agency has not done so.

The ACC is committed to reducing preventable disease and death associated with nicotine addiction. In recent years, the College has repeatedly encouraged the FDA to thoroughly explore the implementation of effective graphic warning labels to inform consumers on the serious dangers associated with cigarette use. ACC Advocacy staff will continue to communicate updates on this issue as they become available.

Clinical Topics: Cardiovascular Care Team, Prevention, Smoking

Keywords: ACC Advocacy, Tobacco, Smoking Cessation, Nicotine, Public Health, United States Food and Drug Administration, Tobacco Products

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