August 15, 2019
3 min read

FDA proposes adding new health warnings, images to cigarette packaging

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The FDA has issued a proposed rule that would require cigarette packaging and advertisements to include new health warnings with photo-realistic images about the lesser-known, but serious, health risks of cigarette smoking, according to an agency press release.

Cigarette packages first featured health warnings in 1966 and were updated in 1984 to include the U.S. surgeon general’s warnings that currently appear on packages and advertisements. However, research indicates that these warnings attract little attention, particularly because of their small size, location, lack of image and unchanged content, the FDA noted in the release.

The agency also stated that the public remains unaware of some of the adverse effects associated with smoking. Consequently, the FDA undertook a science-based approach to develop and evaluate the new proposed cigarette health warnings, which focus on these lesser-known health risks, including bladder cancer, diabetes, erectile dysfunction and conditions that cause blindness.

The FDA has issued a proposed rule that would require cigarette packaging and advertisements to include new health warnings with photo-realistic images about the lesser-known, but serious, health risks of cigarette smoking, according to an agency press release.
Source: Shutterstock

In the FDA’s final consumer research study, participants reported that the information provided by the 13 proposed cigarette health warnings was new to them and that they learned from the proposed warnings when compared with the current U.S. surgeon general’s warnings on cigarette packages and in advertisements.

The proposed new warnings, each comprising a text statement and corresponding photo-realistic image in full color, include:

  • WARNING: Tobacco smoke can harm your children.
  • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
  • WARNING: Smoking causes head and neck cancer.
  • WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
  • WARNING: Smoking during pregnancy stunts fetal growth.
  • WARNING: Smoking can cause heart disease and strokes by clogging arteries.
  • WARNING: Smoking causes COPD, a lung disease that can be fatal.
  • WARNING: Smoking reduces blood flow, which can cause erectile dysfunction.
  • WARNING: Smoking reduces blood flow to the limbs, which can require amputation.
  • WARNING: Smoking causes type 2 diabetes, which raises blood sugar.
  • WARNING: Smoking causes age-related macular degeneration, which can lead to blindness.
  • WARNING: Smoking causes cataracts, which can lead to blindness.

Once finalized, the new cigarette health warnings would occupy the top 50% of the area of the front and rear panels of cigarette packages and at least 20% of the area at the top of cigarette advertisements. Companies would be required to add these warnings to cigarette packaging and advertisements within 15 months after the final rule is issued, according to the agency press release.

This new ruling satisfies the requirements of the Tobacco Control Act, which mandates that the FDA include new warning labels specifically on cigarette packages and in advertisements. After a lawsuit filed by several public health groups, a U.S. District Court for the District of Massachusetts issued an order in March directing the agency to publish the proposed rule by August and issue a final rule in March 2020.


“As a cancer doctor and researcher, I am well aware of the staggering toll inflicted on the public health by tobacco products, which cause cancer, heart disease, stroke, emphysema and other medical problems. While most people assume the public knows all they need to understand about the harms of cigarette smoking, there’s a surprising number of lesser-known risks that both youth and adult smokers and nonsmokers may simply not be aware of, such as bladder cancer, diabetes and conditions that can cause blindness,” Ned Sharpless, MD, acting FDA commissioner, said in the release. “With these new proposed cigarette health warnings, we have an enormous public health opportunity to fulfill our statutory mandate and increase the public’s understanding of the full scope of serious negative health consequences of cigarette smoking. Given that tobacco use is still the leading cause of preventable disease and death in the U.S., there’s a lot at stake to ensure the public understands these risks. We remain committed to educating the public, especially America’s youth, about the dangers associated with using cigarettes and other tobacco products.”

The proposed rule will be open for public comments through Oct. 15. The FDA is seeking comments on the proposed cigarette health warnings, how many warnings should be selected for the final rule and proposals for alternative text and images that are supported by scientific information showing that these alternatives would advance government interest in promoting greater public understanding of the negative health consequences of smoking.