United States

In a lawsuit filed by eight public health and medical groups and several individual pediatricians, plaintiffs filed suit to force the U.S. Food and Drug Administration (FDA) to issue a final rule requiring pictorial health warnings on cigarette packs and advertising, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. The FDA's previous final rule was struck down in August 2012 by the U.S. Court of Appeals for the D.C. Circuit, which ruled that the proposed warnings violated the First Amendment. Ruling in a separate case in March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s requirement for pictorial health 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 meant the FDA was still legally obligated to require pictorial health warnings, and the agency was 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, but had yet to act when plaintiffs filed suit.

The judge agreed with the health groups that the FDA has both “unlawfully withheld” and “unreasonably delayed” agency action to require the pictorial warnings. The judge set a deadline of September 26, 2018, for the FDA to provide an expedited schedule for the proposal, review, and issuance of final pictorial health warnings in accordance with the law.