FDA Rebuked Over Slow Progress Menthol Ban

On Nov. 17, Magistrate Judge Kandis A. Westmore of the United States District Court in the Northern District of California issued a ruling putting the Food and Drug Administration on notice that further delay in issuing a proposed rule on ending the sale of menthol-flavored cigarettes could be constructed as “undue delay” under the Administrative Procedure Act.

In April 2021, the FDA announced that it would begin the rulemaking process in response to a citizen’s petition filed in 2013. The announcement followed a lawsuit filed by the African American Tobacco Control Leadership Council (AATCLC), Action of Smoking and Health, the American Medical Association, and the National Medical Association. Filed on June 17, 2020, the lawsuit asserted that the FDA had failed to act on menthol cigarettes contrary to the duties and mandate imposed by the 2009 Family Smoking Prevention and Tobacco Control Act.

“We applaud District Court Judge Westmore for keeping the FDA’s feet to the fire,” explained AATCLC Co-Chair Phillip Gardiner. “The Black community has been waiting far too long for the FDA to act and protect the health of our people. Ending the sale of menthol cigarettes will be one of the most impactful steps this country can take to save African American lives and advance health equity.”

“We’re very pleased that Judge Westmore agreed that the FDA’s April 29 announcement is a beginning, not an end, for complying with the lawsuit,” said Laurent Huber, executive director of Action on Smoking and Health. “Unfortunately, when it comes to tobacco the FDA has rarely met a deadline, even a self-imposed one. Every delay costs lives.”

Each year, more than 72,000 African Americans are diagnosed with a tobacco-related illness and more than 45,000 die from a tobacco-induced disease, according to the AATCLT. Eighty-five percent of all African American smokers smoke menthol cigarettes compared to 29 percent of White smokers. Menthol cigarettes increase addiction and make it harder to quit. More than 70 percent of African American smokers want to quit, and more than 60 percent made a quit attempt in the previous year. However, African American smokers are less likely than White smokers to successfully quit smoking.