Health Groups and Pediatricians Sue FDA for Cigarette Graphic Warning Regulations

By Stacy L. Ehrlich & Cynthia L. Meyer

On October 4, 2016, several public interest groups (including the American Academy of Pediatrics, American Cancer Society, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative Foundation) and individual pediatricians filed a lawsuit against the U.S. Food and Drug Administration (FDA) in the United States District Court for the District of Massachusetts, seeking to compel FDA to promulgate a final rule requiring cigarette packages and advertisements to bear color graphic images and warnings to comply with Section 201 of the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), which required FDA to promulgate its final rule “not later than 24 months” after the Act was enacted on June 22, 2009.

Although FDA did issue a final rule on June 22, 2011, requiring specific graphic warning labels for cigarettes, on September 2, 2011, a group of tobacco product manufacturers and sellers filed an action in the United States District Court for the District of Columbia, challenging the specific graphic warning requirements as a violation of their First Amendment rights and therefore unconstitutional.  On February 29, 2012, the court found the specific warning labels required by the 2011 final rule were unconstitutional and enjoined the enforcement of the rule.  On August 24, 2012, the U.S. Court of Appeals for the District of Columbia Circuit affirmed the lower court’s decision, vacated the 2011 final rule and the lower court’s permanent injunction, and remanded the final rule to the FDA.

The complaint alleges that FDA has not even begun rulemaking proceedings in order to promulgate a new graphic warnings rule as required by Section 201 of the Tobacco Control Act and notes that no proposed rule appears on FDA’s Unified Regulatory Agenda for action during 2016.

The plaintiffs allege that they have suffered actual and particularized injury as a result of the failure of FDA to issue a graphic warning rule for cigarettes in that such failure makes their respective education and counseling efforts less effective and requires the expenditure of more resources than would be the case if cigarette packages and advertisements included graphic warnings as required under Section 201.  The complaint states that although the earlier graphic warning requirements were found unconstitutional, the courts’ decisions did not suggest that all graphic warning requirements would be unconstitutional or that FDA did not have the power to comply with its statutory obligation to issue constitutionally permissible graphic warnings requirements.

As relief, the plaintiffs ask that the court:

  • Declare FDA to be in violation of the Tobacco Control Act;
  • Issue an order under the Administrative Procedure Act or a writ of mandamus to compel the FDA to submit for the court’s review a proposed timetable for expedited rulemaking in accordance with Section 201;
  • Issue an order under the Administrative Procedure Act or a writ of mandamus to compel the FDA by a certain date to complete notice-and-comment rulemaking on a new rule to implement the graphic warnings requirements of Section 201;
  • Award plaintiffs’ their attorneys’ fees and costs; and
  • Grant such other and further relief as the court deems proper.

FDA must respond to the complaint (e.g., by filing an answer or a motion to dismiss) within 60 days after it has been served.