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FDA Requires New, Larger Cigarette Warnings

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The Food and Drug Administration has issued a final rule requiring new health warnings on cigarette packaging and advertisements which will feature text and photo-realistic images depicting the impact of smoking on fetal growth, cardiac disease, diabetes, and other health risks.

The warnings, which must appear prominently on cigarette packaging and advertising, occupying the top 50% of the front and rear panels and at least 20% of the top of advertisements, will be mandatory starting June 18, 2021.

Specifically, the FDA chose 11 of their originally proposed 13 warnings for the final rule:

  • 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 cataracts, which can lead to blindness.

“The 11 finalized cigarette health warnings represent the most significant change to cigarette labels in more than 35 years and will considerably increase public awareness of lesser-known, but serious negative health consequences of cigarette smoking,” said Mitch Zeller, JD, director of FDA’s Center for Tobacco Products.

“Research shows that the current warnings on cigarettes, which have not changed since 1984, have become virtually invisible to both smokers and nonsmokers, in part because of their small size, location and lack of an image. Additionally, research shows substantial gaps remain in the public’s knowledge of the harms of cigarette smoking, and smokers have misinformation about cigarettes and their negative health effects. The new cigarette health warnings complement other critical FDA actions, including outreach campaigns targeted to both adults and youth, to educate the public about the dangers associated with using cigarettes, as well as other tobacco products.”

—Michael Potts

Reference:
FDA requires new health warnings for cigarette packages and advertisements. News release. Food and Drug Administration; March 17, 2020. Accessed March 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-requires-new-health-warnings-cigarette-packages-and-advertisements.