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Texas Judge Rules Against FDA Graphic Warning Labels for Cigarettes
A federal judge in Texas this week ruled against the graphic warning labels proposed by the FDA for cigarette packaging saying the labels violated tobacco industry free speech. At issue are graphic warning labels proposed by the Agency that include statements about the dangers of cigarette use and images that reinforce the text. Graphic warning labels include:

  • Warning: Smoking causes COPD, a lung disease that can be fatal (accompanied by an image of an older male using supplemental oxygen)
  • Warning:  Smoking causes head and neck cancer (accompanied by an image of a woman with a large growth on her neck)
  • Warning:  Smoking can cause heart disease and strokes by clogging arteries (accompanied by an image of a male with a large surgical scar on his chest)

Under legal precedent, the government can compel companies to display warning labels on consumer products if a) the government has a compelling interest, b) if the information is accurate, factual and non-controversial and if c) the labeling requirement is the least restrictive option of promoting the government’s compelling interest.

Judge Barker found that the images of people, and in particular, their facial expressions, were open to broad interpretation and therefore failed the test of being “accurate, factual or non-controversial” information. Judge Barker’s decision applies only to the proposed graphic warning images and does not block the FDA’s authority to develop a different set of graphic warning labels.

The Tobacco Control Act enacted in 2009 mandates that cigarette packages display graphic warning labels covering 50 percent of the front and rear of cigarette packaging and 20 percent of cigarette advertising. The FDA’s efforts to meet this mandate have been under considerable legal challenge. The tobacco industry initially sued saying any graphic warning label requirement was constitutional. In 2012, a federal court affirmed the FDA’s authority to require graphic warning labels on cigarette packages and the U.S. Supreme Court rejected the tobacco industry’s request for an appeal. That same year, the FDA proposed graphic warning labels that were challenged by the tobacco industry as being impermissible compelled speech. A federal judge agreed and blocked implementation of the first set of proposed FDA graphic warning labels – but did not block the Agency from of issuing revised labels. After waiting nearly five years for the FDA to issue revised graphic warning labels, groups in the public health community sued the Agency, seeking a court order to compel it to issue the labels. It is the second set of graphic warning labels that have been blocked by the Texas judge’s decision.

The ATS will urge the FDA and Department of Justice to appeal the most recent graphic warning label decision. 

Last Reviewed: December 2022