American Academy of Pediatrics, et al. v. U.S. Food & Drug Administration

In 2016, the Campaign for Tobacco-Free Kids, in conjunction with seven other health organizations, medical groups, and several individual pediatricians, filed a lawsuit to force the U.S. Food and Drug Administration (FDA) to issue a final rule requiring graphic health warnings on cigarette packing and marketing, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. In September 2018, the District Court ruled in favor of the health groups finding that the FDA had both “unlawfully withheld” and “unreasonably delayed” agency action to require the graphic health warnings.  

In March 2019, the District Court ordered that the FDA must issue a final rule by March 2020 for graphic health warnings on cigarette packaging and marketing.  The ruling also requires the FDA to finish its study on the labels by April 15, 2019, and submit its proposed rule by August 15, 2019.

For the earlier decision, see: American Academy of Pediatrics, et al. v. U.S. Food & Drug Admin., No. 1:16-cv-11985 (D. Mass. 2018).

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American Academy of Pediatrics, et al. v. U.S. Food & Drug Admin., No. 1:16-cv-11985-IT (D. Mass. 2019).

  • United States
  • Mar 5, 2019
  • U.S. District Court for the District of Massachusetts

Parties

Plaintiff

  • American Academy of Pediatrics
  • American Cancer Society
  • American Cancer Society Cancer Action Network
  • American Heart Association
  • American Lung Association
  • Campaign for Tobacco-Free Kids
  • Dr. Jonathan Winickoff
  • Dr. Lynda Young
  • Dr. Ted Kremer
  • Massachusetts Chapter of the American Academy of Pediatrics
  • Truth Initiative

Defendant U.S. Food and Drug Administration

Legislation Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

None

Type of Tobacco Product

None