The FDA has until March 15 to issue a final rule mandating that cigarette makers place graphic health warnings on cigarette packs and in advertising, a federal judge ruled last week.

The order by U.S. District Judge Indira Talwani of the U.S. District Court for the District of Massachusetts was in response to a lawsuit filed in October 2016 by eight public health and medical groups and several individual pediatricians. In a September 2018 ruling, Judge Talwani agreed with the health groups that the FDA has both “unlawfully withheld” and “unreasonably delayed” agency action to require the graphic warnings.

In response to Judge Talwani’s ruling, the FDA proposed issuing the final graphic warnings rule by May 2021. Instead, Judge Talwani ordered the FDA to issue a proposed rule by August 15, 2019, and a final rule by March 15, 2020.

480,000+ deaths a year

Health organizations are calling the court’s order to expedite the graphic cigarette warnings “a major victory” in the fight against tobacco use, the nation’s No. 1 cause of preventable death. Tobacco kills more than 480,000 Americans and costs about $170 billion in health care expenses each year.

The current U.S. cigarette warnings, which are printed on the side of cigarette packs were last updated in 1984. The American Lung Association characterizes them as “stale and unnoticed” and says they fail to contribute to greater progress in reducing cigarette smoking. Studies around the world have shown that graphic warnings are most effective at informing consumers about the health risks of smoking, preventing children and other nonsmokers from starting to smoke, and motivating smokers to quit.

The 2016 lawsuit was filed by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, Truth Initiative and several individual pediatricians. The plaintiffs have been represented by the legal staff of the Campaign for Tobacco-Free Kids and the Boston law firm of Anderson & Krieger LLP.

Background

The 2009 Family Smoking Prevention and Tobacco Control Act required graphic warnings covering the top half of the front and back of cigarette packs and 20 percent of cigarette advertising and gave the FDA until June 22, 2011, to issue a final rule requiring such warnings. While the FDA met that deadline, the specific graphic warnings required by the FDA were struck down in August 2012 by a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit, which ruled 2-1 that the proposed warnings violated the First Amendment. That ruling only applied to the specific images proposed by the FDA and did not address the law’s underlying requirement.

Ruling in a separate case in March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s requirement for graphic warnings, finding that this provision did not violate the First Amendment. That court found the graphic warnings “are reasonably related to the government’s interest in preventing consumer deception and are therefore constitutional.” The U.S. Supreme Court declined to hear a tobacco industry appeal of this ruling.

Taken together, these two federal court decisions mean the FDA is still legally obligated to require graphic health warnings, and the agency is free to use different images than those struck down by the D.C. Circuit in 2012. The FDA stated in March 2013 that it planned to issue a new rule requiring graphic warnings, but has yet to act.

Bipartisan support

The graphic warnings were mandated by a large, bipartisan majority of Congress, which relied on an extensive scientific record demonstrating the need for the warnings and their effectiveness. Because of this evidence, at least 120 countries now require large, graphic cigarette warnings.