The U.S. Food and Drug Administration (FDA) was sued Wednesday by two anti-smoking groups in the Northern District of California, due to the alleged inaction on its statutory duty to re-evaluate tobacco product standards and enact a rule to ban menthol cigarettes, allegedly leading to the premature deaths of thousands of Americans. The suit seeks to compel FDA action to address a public health crisis.
The African American Tobacco Control Leadership Council (AATCLC) and Action on Smoking on Health (ASH) filed the suit against both the FDA and the Department of Health and Human Services (HSS). The AATCLC alleged that the FDA failed to fulfill its duties under the Family Smoking Prevention and Tobacco Control Act by refusing to resolve a Citizen’s Petition it filed more than seven years ago. The AATCLC is focused on the regulation of flavored tobacco products, specifically the risk menthol cigarettes place on the public.
AATCLC specifically took issue with the FDA’s reversed course on regulating menthol cigarettes that started in June 2019. Before then, the FDA had taken action and steps toward addressing this issue; “in August 2013, FDA announced that it was funding three menthol related studies: one to look at whether genetic differences in taste perception explain why certain racial and ethnic populations are more likely to use menthol cigarettes; the second to compare exposure to smoke-related toxins and carcinogens from menthol and nonmenthol cigarettes; and a third to examine the effects of menthol and nonmenthol compounds in various tobacco products on both tobacco addiction and toxicants of tobacco smoke.” However, the plaintiffs claimed the FDA remained silent about any regulation of menthol cigarettes from the summer of 2013 to the summer of 2017.
In March 2018, the plaintiffs alleged then-FDA Commissioner Scott Gottlieb committed to banning menthol cigarettes due to announcing three advance noticed of proposed rulemaking in a statement: “(1) “to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels”; (2) to “solicit additional comments and data related to the regulation of premium cigars”; and (3) “to seek comment on the role that flavors—including menthol—play in initiation, use and cessation of tobacco products.” The plaintiffs also cited in a New York Times article where then Commissioner Gottlieb noted, “he was revisiting [FDA’s consideration of] the use of menthol in certain products, which has been of particular concern in African American communities targeted by makers of menthol cigarettes like Newport and Kools in years past. ‘It was a mistake for the agency to back away of menthol.’” Alas, in June of 2019 plaintiffs assert that the course to regulate menthol cigarettes for unknown reasons stopped, which has lead to this suit.
The plaintiffs’ requested relief is for the court to declare the FDA has violated the Administrative Procedure Act, and the Tobacco Control Act, as well as an order directing defendants to begin the rulemaking process for adding menthol to the list of banned flavored tobacco.
The plaintiffs are represented by Pollock Cohen LLP.