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FDA Proposes New Graphic Warnings for Cigarettes

  • The Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by Section 201 of the Family Smoking Prevention and Tobacco Control Act (TCA; signed into law on June 22, 2009) directs the U.S. Food and Drug Administration (FDA) to develop graphic warnings for cigarette packages and promulgate regulations requiring the warnings within 24 months of enactment of the TCA.  Accordingly, FDA issued a final rule requiring graphic warnings on June 22, 2011. However, the original graphic warning images did not survive a First Amendment challenge by the tobacco industry (see R.J. Reynolds Tobacco Co. v. FDA), and FDA withdrew the rule.

  • In response to a lawsuit filed against FDA by a coalition of public health groups lead by The Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Heart Association and others, the U.S. District Court for the District of Massachusetts ruled that FDA “unlawfully withheld” or “unreasonably delayed” a revised graphic warning rule because nearly a decade had passed since the TCA was enacted. In March 2019, the Court ordered FDA to publish the new proposed rule by August 2019 and issue a final rule in March 2020.  FDA promulgated a notice of proposed rulemaking on the new cigarette health warnings on August 15, 2019 (available here).

  • The proposed rule would require advertising and packages of cigarettes sold in the United States to include one of thirteen warnings:

    • 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. (This statement is paired with two different images.)

    • 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 age-related macular degeneration, which can lead to blindness.

    • WARNING: Smoking causes cataracts, which can lead to blindness.

  • Under the proposal, each statement is paired with a graphic image, except the COPD statement which is paired with two different images.  The proposed labels, with the accompanying graphic images, can be found here.  Among other requirements, the top fifty percent (50%) of the front and rear panels of the package and 20% of the top of the advertisement would need to provide a graphic warning.

  • For more information, see FDA’s press release, landing page for Cigarette Health Warnings, and Web Feature.  

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 228


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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...