New graphic health warnings that would cover the top 50% of the front and back of cigarette packages and at least 20% of the area at the top of cigarette ads are essential to communicating to Americans the extraordinary range of ways that smoking can harm their health, physicians tell a federal court.

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A Food and Drug Administration (FDA) rule lays out 13 messages, including:

  • WARNING: Tobacco smoke can harm your children.
  • WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
  • WARNING: Smoking reduces blood flow to the limbs, which can require amputation.

Each message would be paired with a photo-realistic image depicting it.

But tobacco companies sued the FDA to stop the requirements that are set to take effect in October 2021, alleging, among other things, that the graphic warnings violate the First Amendment. They, in part, argue that “the government has no substantial interest in improving the public’s understanding of the health harms of smoking, absent evidence that such improved understanding will affect consumer behavior and diminish smoking.” The tobacco companies say the warnings serve only the “purely academic interest” of providing consumers information.

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The Litigation Center of the American Medical Association and State Medical Societies joined the Texas Medical Association, American Academy of Pediatrics and more than a dozen others in an amicus brief that rebuts those arguments. They say increasing what the public knows about smoking’s health hazards is a substantial governmental public health interest.

“The devastating effects of cigarettes on the public health make a mockery of plaintiffs’ assertion that information about those harms serves only a ‘purely academic interest’ of consumers,” the brief filed in the case, R.J. Reynolds Tobacco Company et al. v. U.S. Food and Drug Administration et al., tells the U.S. District Court for the Eastern District of Texas.

“There can be no doubt that the government’s interest in ensuring that consumers are fully informed about the health risks of a product that kills half of its users is not merely to satisfy ‘consumer curiosity.’ Rather, the government’s interest is in giving consumers the tools to make informed decisions about smoking that could profoundly affect their health and well-being.”

The brief cites numerous studies detailing the devastating effects cigarettes have on people’s health and points to studies that show how larger, more direct warnings like these have been effective elsewhere. Cigarette smoking kills more than 480,000 Americans yearly, according to the Centers for Disease Control and Prevention.

Find out more about the cases in which the AMA Litigation Center is providing assistance and learn about the Litigation Center’s case-selection criteria.

Why new warnings are needed

Health warnings on today’s cigarette packs haven’t changed in nearly 35 years and smoking is still the leading cause of preventable disease and death in the United States, accounting for more than 480,000 deaths annually. More than 16 million Americans live with smoking-related diseases and health conditions.

The AMA Litigation Center brief informs the court that a study shows more than half of all survey respondents in one study said they had never heard about health effects depicted in new warnings. It also points to data that shows U.S. smokers had the lowest level of health knowledge among all the countries in the study, both overall and for individual health effects. Among study findings cited in the brief:

  • Only 73% of U.S. smokers agreed that smoking causes stroke.
  • Only 68% agreed that smoking causes lung cancer in nonsmokers.
  • Only 34% agreed that smoking causes impotence.
  • Only 47% of U.S. smokers reported noticing information about the dangers of smoking “often”
  • on cigarette packages, compared with 84% in Canada.

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Large graphic warnings enhance consumer knowledge and are especially important for those with low literacy and for adolescents, the amici tell the court. The graphic elements are not extreme or misleading, they say. And if they evoke an emotional response, it does not make the warnings any less factual.

“A substantial body of scientific research, including evidence from countries where comparable warnings have been in place for many years, demonstrate the effectiveness of large graphic warnings in enhancing public understanding about smoking-related harms,” the brief tells the court, asking the judge to allow the FDA’s rules to go into effect as planned.

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