FDA to require new cigarette package health warnings

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The U.S. Food and Drug Administration (FDA) on March 17 issued a final rule that will require new health warnings on cigarette packages and advertisements consisting of both text and images by 2021.

The 11 new warnings address health risks such as impact to fetal growth, cardiac disease, and diabetes. They will be required beginning June 18, 2021, and include the following:

  • 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 [chronic obstructive pulmonary disease], 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 FDA has issued a guidance to accompany the new rule.

"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," said Mitch Zeller, director of the FDA Center for Tobacco Products, in a statement. "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."

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