FDA requires new health warnings on cigarette packages, ads

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FDA has issued a final rule that requires health warnings on cigarette packages and in cigarette advertisements.

The warnings feature text and 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 and will considerably increase public awareness of lesser-known, but serious negative health consequences of cigarette smoking,” Mitch Zeller, director of FDA’s Center for Tobacco Products, said in a statement. “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.”

Beginning June 18, 2021,health warnings will be required 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 new warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.

Also, FDA has issued a guidance to accompany the final rule.

The final cigarette health warnings each consist of one of the following textual warning statements paired with an accompanying photo-realistic image depicting the negative health consequences of smoking:

  • 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.

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