FDA updates warnings for cigarette packaging, advertisements—compliance required by June 2021

The FDA has published new requirements for the health warnings featured on cigarette packages and in cigarette advertisements. These new warnings will be required beginning on June 18, 2021.

“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,” Mitch Zeller, director of the agency’s Center for Tobacco Products, said in a prepared statement. “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.”

These new warnings must take up “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,” according to the FDA. They emphasize health risks associated with smoking that “are less known by the public,” including the increased risk of bladder cancer.

There are 11 new warnings overall. They “must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements,” according to the FDA. Each warning includes one of the following statements and is accompanied by a photograph:

  • 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.

“By issuing a final rule requiring large, graphic health warnings on cigarette packs and advertising, the U.S. Food and Drug Administration today has taken a critical and long-overdue step forward in the nation’s battle against tobacco use—the number one cause of preventable death,” according to a new statement from the American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative. “The new warnings show and tell the truth about the deadly consequences of smoking and will promote greater public understanding of the many ways in which smoking harms the human body.”