This week, in a rare instance of a court directing a federal agency to take action, the U.S. District Court for the District of Massachusetts ordered FDA to expedite the issuance of a final rule for cigarette graphic warnings. The order comes after the Court concluded that FDA “unlawfully withheld” or “unreasonably delayed” the promulgation of graphic health warnings as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act.

The Tobacco Control Act requires FDA to issue regulations requiring color graphics depicting the health consequences of smoking on product labeling within 24 months after the date of enactment of the Act, or by June 22, 2011. According to FDA, however, the final rule is now expected to be completed in November 2021. Calling this an “extraordinary delay,” the Court stated that FDA’s duty to issue the graphic warnings rule by June of 2011 was “nondiscretionary.” Accordingly, the Court concluded that the statute and deadlines set forth by Congress continue to apply to the FDA — despite the D.C. Circuit’s vacatur and remand back to the agency in R.J. Reynolds Tobacco Co. v. Food & Drug Administration in 2012 based on First Amendment challenges. In coming to this conclusion, U.S. District Judge Indira Talwani stated that “it cannot be the case that the FDA has freed itself from Congressional mandates and may now take the opportunity to promulgate this rule at whatever pace it chooses. While the vacatur may reset the two-year clock, it does not negate the FDA’s continuing obligation to comply with Congress’ deadlines.”

The Court did not accept FDA’s argument that the Agency had competing priorities because FDA failed to identify any single, specific competing priority. The Court also rejected any notion of FDA suffering from limited resources since CTP operations are funded by user fees and the amount of user fees collected in FY 2018 alone was $672,000,000 (even though FDA did not allege that limited resources were at issue in this case). Thus, in light of the original June 2011 timeline set forth by Congress, FDA’s current estimated timeline (and lack of progress in recent years), and the lack of competing priorities outlined in FDA’s brief, the Court found that FDA failed to convincingly show that it did not “unreasonably delay” promulgation of the final graphic health warnings rule for cigarette packs. As such, the court declined to defer to the Agency’s timeline. Instead, the Court has now given FDA a deadline of September 26, 2018 to provide the following:

• an expedited schedule for the completion of outstanding studies for the graphic warnings;
• the publication of the proposed graphic warnings rule for public comment;
• review of public comments, and
• issuance of a final graphic warnings rule.

According to FDA’s own Continue Reading Federal Court Forces FDA’s Hand on Graphic Warning Labels