Oh, How the Tables Have Turned: Court Requires FDA to Follow Law Requiring Graphic Warnings on Cigarettes

September 11, 2018By Anne K. Walsh & David B. Clissold

A district court in Massachusetts scolded FDA for failing to meet a two-year deadline for issuing a final rule mandating color graphic warnings on cigarettes. This decision is important for the public health interests associated with the graphic warnings, but interesting for the loss dealt FDA under the Administrative Procedure Act (“APA”).

As background, the Family Smoking Prevention and Tobacco Control Act of 2009 required FDA to promulgate a final rule mandating color graphic warnings on cigarette packs and in cigarette advertising by June 22, 2011, i.e., two years after Congress enacted the statute. FDA issued a final rule within the two year time period requiring the use of nine text warnings accompanied by graphic images.  A group of tobacco product manufacturers and sellers promptly challenged the rule, alleging that it violated their constitutional right to free speech.  The district court agreed with industry, and the D.C. Circuit upheld the lower court’s decision and vacated the final rule in 2012.

A coalition of physician groups and cancer associations filed the instant suit to force FDA to follow the mandate of the Tobacco Control Act and issue new graphic warnings requirements. They alleged that FDA violated the APA because it “unlawfully withheld” agency action, or in the alternative, “unreasonably delayed” the final rule.  FDA explained to the court that following the 2012 D.C. Circuit decision, the agency formed a working group to research the text of warning statements.  In 2015, FDA contracted with a communications and marketing firm to develop new graphic warning image concepts that were tested in discussion groups.  FDA revised the warnings and then contracted a social science research firm to conduct focus group testing on the revised warnings.  FDA further modified the warnings in response to these results.  FDA explained to the court that additional research was being planned, including another round of focus group review, and two quantitative studies.  The research would then be used to support a formal rulemaking, which FDA estimated would conclude in November 2021.

The Honorable Indira Talwani agreed with the plaintiffs that FDA violated the APA because it both “unlawfully withheld” agency action, and “unreasonably delayed” the final rule.

“Unlawfully Withheld” Standard.  Plaintiff argued that the court should compel agency action here because Congress established a firm, enforceable deadline in the statute.  The district court agreed, highlighting the distinction that exists under the APA when the statute “impose[s] a date-certain deadline on agency action,” and not just a general admonition to act “within a reasonable time.”  The court found that FDA’s duty to promulgate a rule under the Tobacco Control Act is “nondiscretionary”: “Not later than 24 months after June 22, 2009, the Secretary shall issue regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements . . . .”  Even though FDA pointed to its original compliance with the two year deadline before vacatur, the court held that the vacatur “simply return[s] matters to where they stood before,” thus resetting the two-year clock.  The court 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.”

“Unreasonably Delayed” Standard.  The court also walked through the six TRAC factors, named after the D.C. Circuit Court case establishing the test for “unreasonable delay.”

  1. the time agencies take to make decisions must be governed by a rule of reason;
  2. where Congress has provided a timetable or other indication of the speed with which it expects the agency to proceed in the enabling statute, that statutory scheme may supply content for this rule of reason;
  3. delays that might be reasonable in the sphere of economic regulation are less tolerable when human health and welfare are at stake;
  4. the court should consider the effect of expediting delayed action on agency activities of a higher or competing priority;
  5. the court should also take into account the nature and extent of the interests prejudiced by delay; and
  6. the court need not find any impropriety lurking behind agency lassitude in order to hold that agency action is unreasonably delayed.

The court used reprimanding language in its opinion to describe the two year “detour” after the appellate decision vacating the final rule and the “gaps of time where little to no work was completed,” and noted that FDA’s current timeline proposes a period of “four times the initial amount of time set by Congress.” The court also noted that “FDA has not articulated a single higher priority” to justify the “competing priorities” required under the fourth TRAC factor, but requests that the court defer to FDA’s priority choices without regard to those dictated by Congress.  Thus, the court found there was “unreasonable delay” and ordered FDA to provide within three weeks (by September 26, 2018) an expedited schedule for issuing a final rule (including completion of studies, and notice-and comment rulemaking).  The court also offered time for plaintiffs to review and respond to FDA’s proposed schedule, and stated that it intends to direct further action following review of the schedule.

Given the deference typically afforded agencies in their statements of what is a reasonable timeline, this case is a notable win for challenges to agency (in)action. It will be interesting how much FDA’s new schedule shaves off its initial proposed deadline of November 2021, and whether FDA will use this “expedited” schedule as a basis for pushing other competing priorities on the backburner.

Categories: Tobacco