FDA rule mandating graphic warnings on cigarettes blocked by judge

An illustration picture taken in Paris shows cigarettes in their pack, October 8, 2014. REUTERS/Christian Hartmann
  • Judge finds rule would violate companies' First Amendment rights
  • Requirement had been set to take effect October 2023

(Reuters) - A federal judge has blocked a U.S. Food and Drug Administration rule requiring graphic health warnings on cigarette packages and in cigarette advertisements that had been challenged by cigarette companies.

U.S. District Judge J. Campbell Barker in Tyler, Texas, on Wednesday found that the rule, which was to take effect next October, violated the companies' rights under the First Amendment of the U.S. Constitution by compelling speech.

The FDA declined to comment. Lawyers for the companies - which include R.J. Reynolds Tobacco Co, ITG Brands LLC and Liggett Group LLC - did not immediately respond to requests for comment.

The disputed rule, which the FDA finalized in March 2020, would require the use of 11 graphic images, such as images of diseased feet with amputated toes that show possible consequences of cigarette smoking. The warnings must occupy the top 50% of the front and back of cigarette packages and the top 20% of ads.

The tobacco companies sued in April 2020 to block the rule as unconstitutional compelled speech, saying it required them to promote an anti-smoking message. Barker agreed, granting them summary judgment.

He said that under the U.S. Supreme Court's 1985 ruling in Zauderer v. Office of Disciplinary Counsel, the government can require commercial speech if it is accurate, purely factual and uncontroversial.

However, he said images, by their nature cannot be purely factual.

"The image may convey one thing to one person and a different thing to another," he said.

He also said that some of the images could be understood to convey factual claims that may not be accurate. For example, an image of a person with a scar from open heart surgery could be understood to suggest that such surgery was the most common treatment for smoking-related heart disease, for which the FDA had not offered any evidence.

"The imagery in the warnings here is provocative," the judge wrote. "As to each warning, it is not beyond reasonable probability that consumers would take from it a value-laden message that smoking is a mistake."

The case is R.J. Reynolds Tobacco Co et al v. U.S. Food and Drug Administration, U.S. District Court, Eastern District of Texas, No. 6:20-cv-00176.

For R.J. Reynolds: Ryan Watson of Jones Day

For ITG Brands: Philip Perry of Latham & Watkins

For Liggett Group: Meaghan VerGow of O'Melveny & Myers

For FDA: Michael Baer of the U.S. Department of Justice

Read more:

IN BRIEF: Tobacco companies challenge latest FDA graphic warning rule

IN BRIEF: D.C. judge questions cig cos' standard for PI in graphic labels fight

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Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.