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Court Orders FDA to Move Forward with Graphic Warning Labels

This week, U.S. District Judge Indira Talwani ordered the Food and Drug Administration to move forward expeditiously to require graphic warning labels on tobacco products.  The Family Smoking Prevention and Tobacco Control Act of 2009 required the FDA to develop graphic warning labels on all regulated tobacco products.  The FDA had developed such warning labels, but a court struck down the content of the specific labels in 2012, while a separate court ruled that the agency still had the authority and obligation to develop them. Since the 2012 court decisions, the FDA has taken no further public action on graphic warning labels.

Noting the lack of FDA action since 2012, a coalition of physician tobacco control groups sued the agency for its failure to take action.  District Judge Talwani agreed and ordered the FDA to prepare an “expedited schedule for the completion of outstanding studies, the publication of the proposed graphic warnings rule for public comment, review of public comments, and issuance of a final graphic warnings rule in accordance with the Tobacco Control Act” by Sept. 26.  While the court-ordered schedule will not result in the immediate development of graphic warning labels, it will force FDA into action in the foreseeable future.

Last Reviewed: September 7, 2018