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American Academy of Pediatrics, et al. v. FDA

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 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).