ACS, ACS CAN, and Partner Groups Celebrate Victory in Lawsuit to Force FDA to Issue Rule on Graphic Warnings

October 29, 2019

In September of 2018, a federal judge ruled in favor of ACS, ACS CAN and other public health groups that the Food and Drug Administration (FDA) must expedite a rule requiring graphic warnings on cigarette packages and advertisements.  And in March of this year, the court ruled in our favor again, ordering the agency to publish a proposed rule by this August, and setting March 15, 2020 as the date by which FDA must issue a final rule.  This timeline was much closer to our proposed timeline than the government’s.

The FDA met the deadline for the proposed rule, requesting public comment on 13 pictorial images, including one devoted to bladder cancer and another for head and neck cancers. After a thorough analysis of the proposed rule, ACS CAN joined with 39 other public health groups in comments supporting the warnings, providing scientific data and legal arguments to bolster the agency’s actions in the inevitable legal challenge that will be coming from the tobacco industry. 

By way of background, the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA) 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 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 done virtually nothing to date. Several of the groups that joined the lawsuit have repeatedly written the FDA to urge that it do so.

The Administrative Procedure Act, which governs federal agencies like the FDA, gives federal courts the power to “compel agency action unlawfully withheld or unreasonably delayed.” The lawsuit alleged that the FDA’s failure to issue a new rule requiring graphic warnings is “agency action unlawfully withheld.” The court agreed, and ordered the FDA to propose a timeline for issuing a new rule for graphic warnings. 

In response to the government’s proposed timeline of finalizing a rule in May of 2021, plaintiff groups responded by asking for completion by the end of January, 2020.

The lawsuit was filed in the U.S. District Court for the District of Massachusetts. Plaintiff groups include 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. Read the complaint and the press release.