Synopsis

Public health groups sued the FDA over its failure to prohibit the sale of menthol cigarettes.

Why It Matters for Public Health

This case illustrates how public health groups were able to use the law to hold the FDA’s feet to the fire, specifically for its failure for years to prohibit the sale of menthol cigarettes, which disproportionately impact African American, LGBTQ+, Latine, and other communities that the tobacco industry has targeted. The lawsuit also challenged the FDA’s failure to respond to a citizen petition that was submitted by public health groups in 2013, asking the agency to prohibit menthol in cigarettes.

Background

The Tobacco Control Act (TCA) prohibits the sale of flavored cigarettes, but it has expressly exempted menthol and tobacco flavors since its enactment in 2009. The TCA requires the FDA to reevaluate tobacco product standards, including this special rule for cigarettes, on a periodic basis. The FDA had not reevaluated the product standard, nor had it taken any action to issue a product standard prohibiting the sale of menthol cigarettes.

Proceedings

On June 17, 2020, the African American Tobacco Control Leadership Council (AATCLC) and Action on Smoking and Health (ASH) filed a lawsuit against the FDA in the Northern District of California, alleging unreasonable delay on the part of the agency in banning menthol in cigarettes. Specifically, their lawsuit alleged:

1. Despite thousands of pages of data, two separate, detailed reports, two Advanced Notices of Proposed Rulemaking evidencing the FDA’s intent to begin the rulemaking process for banning menthol, and the TCA’s requirement that the FDA periodically reevaluate existing tobacco product standards, the agency failed to act to prohibit menthol in cigarettes, which is actionable as “unreasonable delay” by an agency under the Administrative Procedure Act (APA);
2. The agency never provided any substantive response, as required by the APA and the FDA’s regulations, to the 2013 citizen petition from AATCLC and other public health groups to the FDA that requested for it to begin the rulemaking process to ban menthol in cigarettes; and
3. As an alternative claim, the plaintiffs alleged that the FDA’s intentional pivot away from addressing menthol constituted an arbitrary and capricious action that must be reversed.

The groups requested several forms of relief from the court, including an affirmative order requiring the FDA to begin a rulemaking process to address menthol to the list of characterizing flavors in cigarettes, an order requiring the FDA to respond to the citizen petition, and an order requiring FDA to reevaluate the tobacco product standards as required by the TCA.

The American Medical Association joined the lawsuit as a plaintiff on September 3, 2020. On September 2, 2021, the Public Health Law Center filed a motion to participate as an amicus. The government opposed that motion. The Center argued in its brief that the court should not dismiss the case because the FDA had still not issued a rule that would implement a menthol ban. Instead, the government had merely stated its intent to act on menthol at some point in the future, which it has done numerous times before. A copy of the Center’s citizen petition is available here.

On November 17, 2021, the court decided to hold the motion to dismiss in abeyance until May of 2022. In its order, the court noted that the FDA was not required to issue a notice of rulemaking in order to make a determination on the citizen petition, explaining that the primary issue remaining was whether FDA is unduly delaying an action. Looking to guidance from case law, the court found that a delay of a few months or a few years may be reasonable “unless there is something more, e.g., a threat to human welfare. Such a threat could be found here.”

On April 29, 2021, the FDA announced that it planned to issue a rule prohibiting menthol in cigarettes by April of 2022. The FDA then filed a motion to dismiss the lawsuit. On November 17, 2021, the court chose to hold the motion to dismiss in abeyance until May of 2022, to correspond with when the FDA was expected to issue a Notice of Rulemaking, with the hearing on the motion to dismiss to be revisited on June 2, 2022.

The FDA has accepted comments on its proposed rule and has expressed its intent to issue a final rule by late 2023.

Litigation Status (CLOSED)

On April 28, 2022, the FDA released a proposed rule prohibiting the sale of menthol cigarettes. On June 1, 2022, the plaintiffs announced their support for dismissal in light of the FDA’s action. The FDA accepted comments on the proposed rule and has expressed its intent to issue a final rule by late 2023. The case is substantively closed, with only lingering attorney fee matters remaining.