FDA Appeals Court’s Graphic Cigarette Health Warnings Decision

Agency’s rule was invalidated in December
FDA graphic cigarette health warnings
Photograph courtesy of the FDA

The Food and Drug Administration has appealed a court’s order that found the agency’s graphic cigarette health warning rule unconstitutional.  

On Dec. 7, the U.S. District Court of the Eastern District of Texas issued the decision vacating the FDA’s graphic cigarette health warning regulations, saying they violated free speech protections under the First Amendment. The FDA then appealed that decision on Feb. 1 in the U.S. Court of Appeals for the Fifth Circuit, according to court documents. The agency declined to comment on the appeal to CSP Daily News.

The graphic cigarette health warning rule required manufacturers and retailers who sell cigarettes to rotate 11 health warnings on cigarette packs, which consisted of textual statements and color graphics depicting the negative health consequences of cigarette smoking.

The FDA first issued a version of the rule in 2011 and then introduced a second rule in March 2020 with the new set of 11 graphic cigarette health warnings. Shortly after, two lawsuits were filed against the FDA by R.J. Reynolds Tobacco Co., Santa Fe Natural Tobacco Co., ITG Brands LLC, Liggett Group LLC and several other companies, including retailers. Philip Morris USA Inc. and Sherman Group Holdings, LLC filed a second lawsuit.

The Dec. 7 decision involved the first lawsuit filed by Winston-Salem, N.C.-based R.J. Reynolds and other plaintiffs. In it, the court said the graphic cigarette health warnings would have compelled manufacturers and retailers to speak by displaying cigarette packages on store shelves and advertising cigarettes when, if given the choice, manufacturers and retailers would choose not to do so. The court also said the warnings were not purely factual and were open to interpretation by consumers and more extensive than necessary.

The rule was set to take effect in November 2023, but that deadline had been extended many times.  

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