Public health groups sue 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 can use the law hold the FDA’s feet to the fire for its ongoing failure to prohibit the sale of menthol cigarettes, which disproportionately impacts African American, LGBTQ+, Latinx, and other communities that have been historically and intentionally targeted by the tobacco industry. The lawsuit also challenges the FDA’s failure to respond to a citizen petition that was submitted by public health groups in 2013 asking it to prohibit menthol in cigarettes. The agency responded to the petition on April 29, 2021, and indicated that it plans to begin a rulemaking to prohibit menthol in cigarettes. The case is ongoing, as the FDA has yet to issue a proposed rule.
The Tobacco Control Act prohibits the sale of flavored cigarettes, but it has expressly exempted menthol and tobacco flavor since its enactment in 2009. The Act requires the FDA to reevaluate the tobacco product standards, including this special rule for cigarettes, on a periodic basis. FDA has not reevaluated the product standard, nor has it taken any action to issue a product standard prohibiting the sale of menthol cigarettes.
District Court 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 alleges:
- Despite thousands of pages of data, two separate, detailed reports, two Advanced Notices of Proposed Rulemaking evidencing FDA’s intent to begin the rulemaking process for banning menthol, and the Tobacco Control Act’s requirement that the FDA periodically reevaluate existing tobacco product standards, the agency has failed to act to prohibit menthol in cigarettes, which is actionable as “unreasonable delay” of agency action under the Administrative Procedure Act (APA);
- The agency has never provided any substantive response as required by the APA or FDA’s regulations to AATCLC and other public health groups’ 2013 petition to FDA to begin the rulemaking process to ban menthol in cigarettes; and
- As an alternative claim, the plaintiffs allege that FDA’s intentional pivot away from addressing menthol constitutes an arbitrary and capricious action that must be reversed.
The groups request several forms of relief from the court, which include 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 Act.
The American Medical Association joined the lawsuit as a plaintiff on September 3, 2020. On September 18, 2020, the government defendants filed a motion to dismiss the two non-petition claims. A hearing on the motion took place on November 5, 2020.
On November 12, 2020, Judge Westmore issued an order partially granting and partially denying the government’s motion to dismiss. The order allowed the first claim alleging unreasonable delay on the part of the agency to reevaluate the product standard to move forward. Judge Westmore dismissed the third claim alleging that FDA had taken any action to not act on menthol. Because the claims were made in the alternative to one another, this was an expected outcome.
As for the petition claim, the FDA had indicated that it planned to respond to the petition by January 29, 2021. The Public Law Center and AATCLC, among other groups, filed a supplement to the citizen petition on January 14, 2021. In light of the supplement, the parties agreed to allow for a 90-day extension of the time to respond to the petition. On April 29, 2021, the FDA responded to the citizen petition by letter, indicating it plans to grant the petition and issue a rule prohibiting menthol in cigarettes. The response does not commit to a specific timeline, but instead states that the agency plans to issue a proposed rule within a year. Please see the Public Health Law Center’s document on the FDA’s response for more information.
Because the FDA did not commit to a specific timeline, the plaintiffs filed a Supplemental Complaint on May 21, 2021. On June 9, 2021, the FDA filed a motion to dismiss the lawsuit on the grounds that they have complied with the plaintiffs request and there is no further relief that the court can grant. The plaintiffs filed a response to that motion on July 7, 2021, and a hearing on the motion was scheduled for September 16, 2021.
On September 2, 2021, the Public Health Law Center filed a motion to participate as an amicus curiae. The government opposed that motion. The Public Health Law Center’s brief argues that the court should not dismiss the case because the FDA has still not issued a rule that will implement a menthol ban. Instead, the government has 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 Public Health Law Center’s proposed brief is available here. On September 7, 2021, Judge Westmore issued an order requiring further briefing from the parties on the Plaintiffs’ position and the letter received in response to the petition. The parties submitted their supplemental briefing on the issue of undue delay in light of the agency’s response to the citizen petition. Meanwhile, additional public health groups submitted a second motion participate as amicus curiae in late September, which was partially granted. The hearing on the motion to dismiss has been postponed until November 18, 2021.
On November 17, 2021, the Court held that the motion to dismiss will be held in abeyance until May, 2022. In its order, the Court noted that FDA does not have a requirement to issue a notice of rulemaking in order to make a determination on the citizen petition, resolving that the primary issue remaining is whether FDA is unduly delaying an action. Looking to guidance from caselaw, 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.” The Court concludes that “whether the FDA issues the Notice of Rulemaking as currently planned is potentially determinative to the Court’s disposition of the pending motion to dismiss. The motion to dismiss will be revisited on June 2, 2022.
The case is ongoing. The FDA announced on April 29, 2021 that it plans to issue a rule prohibiting menthol in cigarettes by April 2022. The FDA has filed a motion to dismiss the lawsuit. A hearing on the motion to dismiss is scheduled to take place on November 18, 2021. On November 17, 2021, the court held that the motion to dismiss will be held in abeyance until May, 2022 to correspond with when FDA expects to issue a Notice of Rulemaking, with the hearing on the motion to dismiss to be revisited on June 2, 2022.