“The most significant change to cigarette labels in more than 35 years”


The U.S. Food and Drug Administration issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements.

The warnings will feature serious health risks of cigarette smoking along with photo-realistic color images.

  • 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

Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products.

Beginning June 18th of next year these new cigarette health warnings will be required to 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.

The new warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.

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.

Mitch Zeller, J.D.

The agency undertook a science-based approach to develop and evaluate the new cigarette health warnings.

These warnings focus on serious health risks that are less known by the public. For example, current smokers have been found to have almost four times the risk of bladder cancer as people who have never smoked.

While the proposed rule put forward 13 warnings for consideration, the FDA finalized a set of 11 required warnings for the final rule.

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