Court Directs FDA to Issue Final Graphic Cigarette Warning Rule by March 2020

BOSTON — A federal judge gave the Food and Drug Administration (FDA) 12 months to release its final rule graphic warning for cigarette packs and advertising.

On March 5, Judge Indira Talwani in the U.S. District Court for the District of Massachusetts ordered the FDA to comply by March 15, 2020. The ruling also requires the agency to finish its study on the labels by April 15 and submit its proposed rule by Aug. 15, according to the Winston-Salem Journal.

The issue of graphic warnings dates back several years. The 2009 Family Smoking Prevention and Tobacco Control Act specified that cigarette packages and advertisements have larger and more visible graphic health warnings. 

In June 2011, the FDA issued its final nine health warnings, which were set to appear on every cigarette pack and ad by September 2012.

However, the graphic warnings were struck down in 2012 after a challenge by several tobacco companies, including Lorillard Inc., R.J. Reynolds Tobacco Co., Commonwealth Brands Inc. and Liggett Group LLC. In a 2-to-1 decision, the U.S. Court of Appeals in Washington, D.C., affirmed a lower court ruling that the requirement violated the First Amendment's free speech protections, as Convenience Store News previously reported.

In October 2016 the case moved to Boston when eight public health and medical groups, and several individual pediatricians, filed a lawsuit in the U.S. District Court for the District of Massachusetts to force the agency to issue a final rule requiring the warnings on cigarette packs and advertising, as mandated by the Tobacco Control Act.

The FDA, in responding to the lawsuit, set November 2021 for the final rule.

On Sept. 5, 2018, Talwani ordered the FDA to provide the court with an expedited schedule for publication of the new proposed warnings. The agency came back with a May 2021 publication date; however, the judge rejected that date last week.

"The court finds no reason for further delay," Talwani wrote. "Defendant shall take all steps necessary ... and shall complete the study by April 15."