No. 3:20-cv-04012 (N.D.Cal.)
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 has committed to respond to the petition by April 29, 2021.
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 initially 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 have agreed to allow for a 90-day extension of the time to respond to the petition, meaning the FDA will respond to the petition by April 29, 2021. The parties have also agreed to allow the FDA until April 29, 2021, to respond to the petition. Deadlines related to the remaining claim will be stayed pending FDA’s substantive response to the petition.
The case is ongoing. The FDA and the plaintiffs have agreed to an extension of the time to respond to the citizen petition by April 29, 2021.