New Warnings for Cigarette Packs in 2021

FDA says health messages will address lesser-known risks of smoking
Cigarette Packs
Photograph courtesy of the U.S. Food and Drug Administration

WASHINGTON — Starting next year, cigarette packs will have new warning labels that will feature statements and “photo-realistic” color images depicting health risks, officials with the U.S. Food and Drug Administration (FDA) said.

In a March 17 announcement, the FDA said it had issued its final rule to require new health warnings on cigarette packages and in cigarette advertisements. The 11 separate warnings feature “textual statements with photo-realistic color images depicting some of the lesser-known but serious health risks of cigarette smoking, including impact to fetal growth, cardiac disease, diabetes and more.”

“The 11 finalized cigarette health warnings represent the most significant change to cigarette labels in more than 35 years,” said Mitch Zeller, director of the 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.”

Research shows substantial gaps remain in the public’s knowledge of the harms of cigarette smoking, he said, and smokers have misinformation about cigarettes and their negative health effects.

Beginning June 18, 2021, the FDA will require these new cigarette health warnings to appear prominently on cigarette packages and in advertisements, occupying 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. Once implemented, the agency will require that the new warnings be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.

As the FDA outlined in the proposed rule issued last year, the agency said it undertook a science-based approach to develop and evaluate the new cigarette health warnings. Here is the text for the new warnings:

  • 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.

In addition, the FDA has issued a guidance document called Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide to help small businesses understand and comply with the final rule, the agency said.

[Editor’s note: On April 3, several tobacco companies filed a lawsuit against the FDA seeking to invalidate the new warning labels.]

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