Supplement to Second Amendment Complaint Filed in Flavored Cigarette Ban Case

The African American Tobacco Control Leadership Council, Action on Smoking and Health, American Medical Association, and National Medical Association filed a supplement to the second amended complaint in their case against the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Center for Tobacco Products, and their accompanying officials over allegations that their inaction in banning menthol cigarettes led to “millions of people initiating smoking cigarettes, and thousands of premature deaths.” Specifically, the plaintiffs assert the disproportionate effect this has had on black Americans.

In 2009, the Obama Administration passed the Tobacco Control Act, which is commonly referred to as “the flavor ban,” an act authorizing the FDA to prohibit menthol cigarettes. In the legislation, Congress recognized that not only do menthol cigarettes “pose unique health risks to those who smoke them,” but also that African American smokers used menthol cigarettes at a higher rate than other groups due to targeted advertising. This disproportionality is what led Congress to prioritize legislation on menthol cigarettes, the complaint said.

After the act was passed, the FDA created the Tobacco Products Scientific Advisory Committee (TPSAC). TPSAC was directed to immediately take on the issue of menthol cigarettes and reevaluate the implemented flavor ban from time to time in order to determine “whether such standard should be changed to reflect new medical, scientific, or other technological data.” Following research, the complaint said, TPSAC ultimately recommended that the ban of menthol cigarettes would “benefit public health in the United States.” The FDA also concluded that menthol cigarettes are linked to beginning smoking at a younger age, developing a stronger addiction, and pose a risk that is “not seen with nonmenthol cigarettes.”

Despite the findings, the FDA took no action to implement new regulations until 2018, the filing offered. Then, in June 2019, they backtracked altogether and said they would allow menthol cigarettes to remain on the market. The plaintiffs claim this decision was reached “without engaging in any reasoned decision-making or providing any coherent explanation.”

As a result of the inaction by the FDA, the plaintiffs argued that the defendants have harmed the public health and that their “years of inaction and unreasonable refusal to act on this issue have almost certainly contributed to the increasing harms associated with menthol in cigarettes.” Further, they asserted that the failure to ban menthol cigarettes has caused COVID-19 to have a disproportionate effect on black Americans, since individuals who smoke are at a greater risk than the rest of the population.

On April 29, the FDA announced that they intended to ban menthol cigarettes, but they have yet to take any action. Some officials even noted that it may be a year or more before the rulemaking process begins. The plaintiffs believe this timeline is “indefensible, and only serves to confirm that judicial oversight and intervention will be required.”The plaintiffs are represented by Pollock Cohen LLP.