Judge Finds FDA’s Graphic Cigarette Health Warnings Unconstitutional

R.J. Reynolds Tobacco Co. wins lawsuit
FDA cigarette health warnings
Photographs courtesy of the FDA

SILVER SPRING, Md. — A federal judge has found the U.S. Food and Drug Administration’s graphic cigarette health warning regulation to be unconstitutional. This means manufacturers and retailers who sell cigarettes no longer need 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 U.S. District Court for the Eastern District of Texas on Dec. 7 issued the decision vacating the FDA’s graphic cigarette health warning regulations because the regulations violate free speech protections under the First Amendment, according to a copy of the decision, provided by the National Association of Tobacco Outlets (NATO).

This follows years of back and forth between cigarette manufacturers and the FDA. 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, NATO said. 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 Tobacco Co. 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, NATO said. 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.   

Matt Domingo, senior director of external relations at Reynolds Marketing Services Co., told CSP the company is pleased the court has invalidated the FDA's proposed graphic warnings. 

“This decision is another example of the ways Reynolds supports and works with our retail and supplier partners beyond day-to-day commercial activities, Domingo said. “Aside from Reynolds, two plaintiffs in this suit were retailers, who described the irreparable harm implementing the FDA’s proposal would cause their businesses. This case is just one example of Reynolds and its partners working together to  challenge what we believe to be unlawful regulatory overreach.”

The FDA declined to comment. 

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