American Academy of Pediatrics v. U.S. Food & Drug Administration (2016)

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Status: Closed

Docket No. 1:16-cv-11985 (D. Mass. Oct 04, 2016)

Synopsis

Public health groups sued the FDA to compel the agency to require graphic warning labels on cigarette packages and advertisements. The public health groups won. FDA appealed, but dropped the appeal after it issued a new graphic warning rule in March, 2020.

Background

On October 4, 2016, several public health groups filed a lawsuit seeking to compel the FDA to issue a rule establishing graphic warning labels for cigarettes. The Tobacco Control Act (“TCA” or “Act”) requires the FDA to issue such a rule. The agency issued a rule in 2011 establishing such warnings but the rule was challenged by the tobacco industry and was eventually struck down because, according to the D.C. Circuit Court of Appeals, the FDA “failed to present any data…showing that enacting their proposed graphic warnings [would] accomplish the agency’s stated objective of reducing smoking rates.”1

Even though FDA had indicated as of 2013 that it intended to undertake research to support new graphic warning rules, FDA failed to revise its rule or revisit its charge to issue graphic warning label requirements. In the face of five years of slow movement on the part of FDA, public health groups sued under the Administrative Procedure Act (“APA”) to obtain a court order compelling FDA to act and issue the rule. The public health groups argued that because there are currently no graphic warnings on cigarette packages, the FDA had violated the provision of the Act that requires it to establish graphic warnings.

District Court Proceedings

FDA filed its answer to the public health groups’ complaint on February 10, 2017. On April 28, 2017, the public health groups filed a motion for summary judgment, and on May 26, 2017, the FDA filed its brief in opposition, along with its own cross-motion for summary judgment. A hearing on the motions was held on January 24, 2018.  

On September 5, 2018, the court issued an order finding that FDA “unlawfully withheld” or “unreasonably delayed” promulgating a final rule mandating color graphic warnings on cigarette packs and in cigarette advertisements. The court issued an order requiring FDA to expedite its plans to issue a final rule. Specifically, the court required FDA to complete outstanding studies, publish its proposed rule for public comment, and issue its final rule.

On October 5, 2018, FDA filed its intended “expedited schedule,” which anticipated finalizing the completion of one outstanding study by May of 2019, submitting its Notice of Proposed Rulemaking for publication in the Federal Register by April of 2020, completing review of comments on that proposed rule by December of 2020, and issuing its final rule by May of 2021. On October 17, 2018, the public health groups filed a response to FDA’s proposed schedule, and renewed their request for a court order mandating more immediate action from FDA. The public health groups specifically raised concerns regarding the “massive adverse health consequences associated with smoking and the importance of the graphic warnings Congress mandated in 2009,” and asked that the court impose a proposed schedule that would result in the promulgation of a final rule by the end of January, 2020.  In late December, 2018, the public health groups filed a motion requesting that the court issue injunctive relief, setting firm deadlines for FDA action.

On March 5, 2019, the court rejected FDA’s proposed timeline, and set deadlines of April 15, 2019 for completing a final qualitative study, August 15, 2019 for issuing a proposed rule, and March 15, 2020 for publishing a final rule in the Federal Register. FDA filed a notice of appeal on May 20, 2019. A briefing schedule was set on June 18, 2019, but on July 18, 2019, shortly before its opening brief was due, FDA filed a motion to hold the case in abeyance because “an appeal may become unnecessary in light of FDA’s ongoing rulemaking proceedings,” as it “anticipated meeting the August 15, 2019 deadline for issuance of the proposed rule.” Because FDA did not, at that time, know whether it would meet the March 15, 2020 deadline to issue the final rule, it asked that the court hold the case in abeyance pending the need for further review.

Such review was ultimately unnecessary, as FDA published the rule in the March 18, 2020 Federal Register. The final version of the rule is available on this webpage

Litigation Status

The case is closed, as FDA issued its final rule in March of 2020.

Case Documents & Information