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FDA to require new health warnings for cigarette packages and ads

Beginning June 18, 2021, these new cigarette health warnings will be required to appear prominently, 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.

Here is a statement from ACS CAN:

"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. 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. 

View the final warnings.

The graphic warnings are a dramatic improvement over the current text-only warnings, which have become stale and unnoticed since they were last updated in 1984. They are supported by extensive scientific evidence and will help the United States catch up to the 120-plus countries that have adopted this best-practice strategy to reduce tobacco use and save lives. 

By law, the new warnings are required to appear on cigarette packs and ads 15 months after a final rule is issued (June 18, 2021). The FDA must now ensure these warnings are fully implemented and vigorously defended against likely legal challenges by the tobacco industry. Congress first mandated graphic cigarette warnings more than 10 years ago and we cannot afford more delays – not when tobacco use still kills half a million Americans, sickens millions more and costs the nation $170 billion in health care expenses each year. The FDA’s rule makes a comprehensive and compelling case for the graphic warnings that shows they stand on firm scientific and legal ground. The rule is also entirely consistent with what Congress required in the 2009 Family Smoking Prevention and Tobacco Control Act.

The FDA faced a court-ordered deadline of March 15 to submit to the Federal Register a final rule requiring the graphic warnings as a result of a successful lawsuit filed by our public health and medical organizations and several individual pediatricians in October 2016 (the court’s order required that the final rule be submitted to the Federal Register for publication by March 15). Our lawsuit sought to force the FDA to comply with provisions of the Tobacco Control Act, which required graphic warnings covering the top half of the front and back of cigarette packs and 20 percent of each cigarette ad.

In a September 2018 ruling, Judge Indira Talwani of the U.S. District Court for the District of Massachusetts found the FDA “unlawfully withheld” and “unreasonably delayed” agency action to require the graphic warnings. Judge Talwani subsequently ordered the FDA to issue a proposed rule by August 15, 2019, and a final rule by March 15, 2020.

The lawsuit was filed by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, Truth Initiative and several individual pediatricians. The plaintiffs have been represented by the legal staff of the Campaign for Tobacco-Free Kids and the Boston law firm of Anderson & Kreiger LLP."

The final cigarette health warnings each consist of one of the following textual warning statements paired with an accompanying photo 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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