In a bit of good news for the tobacco control community, last week a District Court judge in Massachusetts ordered the Food and Drug Administration to finalize requirements to post graphic warning labels on tobacco products by March 2020.  Judge Talwani ruled that the FDA had “unlawfully and unreasonably delayed” development and finalization of graphic warning labels for cigarettes.

The court action is in response to a suit filed by the American Academy of Pediatrics and other health organizations seeking to compel the Food and Drug Administration to meet its statutory obligation to require graphic warning labels on all cigarette packages.  In response to a court order, the FDA had initially proposed to complete work on graphic warning labels by May 2021.  The court rejected the FDA’s schedule and instead has required that the Agency  issue a proposed graphic warning label by Aug. 15, 2019 and complete requirements for a graphic warning label for cigarette packages by March 2020. 

The Tobacco Control Act of 2009 gave the FDA authority to regulate all tobacco products and the law specifically required that the Agency enforce graphic warning labels on cigarette packaging by June 2011.  During the Obama Administration, the FDA finalized graphic warning labels, but in 2012 a U.S. Court of Appeals struck down the specific warning labels, saying the label content violated commercial free speech.  However, that same year, a separate court ruled that requiring graphic warning labels on cigarette packages was a permissible government activity.  The result of the two court decisions was that the FDA’s initial graphic warning labels were rejected, but the Agency was still required to develop graphic warning labels that the court found acceptable. 

Since the court struck down the initial FDA warning labels, the FDA has taken no further action on warning labels.