African American Tobacco Control Leadership Council v. United States Department…

Background

The plaintiffs submitted a citizen petition to the Food and Drug Administration (FDA) in 2013, asking the agency to add menthol to the Tobacco Control Act’s flavor ban. After this lawsuit was filed, the FDA granted the petition on April 29, 2021, and stated that it intended to publish a notice of proposed rulemaking within a year.

The defendants moved to dismiss the case as moot, arguing that granting the petition resolved the plaintiffs’ request. The plaintiffs responded that the FDA had not actually completed its action because it had not issued a notice of proposed rulemaking. They also argued that, even if the FDA’s response was legally sufficient, the agency had unreasonably delayed issuing the notice.

Court’s analysis

The court rejected the plaintiffs’ argument that the FDA was legally required to issue a notice of proposed rulemaking in order to make a determination on the petition. It explained that the cited federal statute addressed a determination set out in a proposed rule but did not require every determination to appear in such a rule.

The court also concluded that the regulation requiring the FDA Commissioner to take “appropriate action” after approving a petition did not necessarily require a notice of proposed rulemaking. The court treated such a notice as one possible example of appropriate action rather than the only permissible action.

The remaining issue was whether the FDA had unreasonably delayed issuing the notice. The court discussed the factors used to evaluate unreasonable agency delay and noted that the FDA expected to issue the notice by April 2022. It stated that if the FDA did not issue the notice within a year after granting the petition, the delay could be unreasonable, particularly given the potential threat to human welfare and the agency’s description of a final rule banning menthol as a high priority.

Disposition

Because the FDA’s planned rulemaking could affect whether the motion to dismiss should be granted, the court held the defendants’ second motion to dismiss in abeyance. It continued the hearing to June 2, 2022, and ordered the parties to file a joint status report by May 2, 2022, stating whether the notice had been issued and how it affected their positions. Judge Kandis Westmore did not otherwise resolve the motion to dismiss in this order.