Under pressure from the tobacco companies Congress exempted menthol from the ban on “characterizing flavors” in cigarettes and other regulated tobacco products when it passed the 2009 Family Smoking Prevention and Tobacco Control Act that gave FDA authority to regulate tobacco products. During the negotiations a group of former Secretaries of Health and others criticized the bill because, “It sends a message that African American youngsters are valued less than white youngsters.” Now the new Biden Administration is being forced to address this exemption by April 29, 2021.
The eventual political compromise in the 2009 law was for Congress to direct the FDA to complete a study on menthol within a year. The FDA’s Tobacco Products Scientific Advisory Committee completed this process on time, and in 2011 TPSAC concluded that the “[r]emoval of menthol cigarettes from the marketplace would benefit public health in the United States.”
This language is important because the standard for FDA action in the law is “appropriate for the protection of public health.”
The FDA did not act on this report and in April 2013 the Tobacco Control Legal Consortium (now called the Public Health Law Center) together with 18 other health organizations filed a citizen’s petition calling on the FDA to begin the process of rule making to remove menthol from cigarettes.
While the FDA completed its own study (that reached essentially the same conclusion as the TPSAC report), collected information on menthol, and funded research on menthol that continued to build the already-strong case that menthol should be banned, the FDA did not issue any regulations.
The FDA did, however, try to include menthol in strong flavor restrictions for e-cigarettes and other products covered by its 2016 “deeming” rule, but the Obama White House cut all the flavor restrictions before issuing the rule. Perhaps reflecting a similar fate under the Trump White House, the rule banning menthol in cigarettes that the FDA announced in 2018 never appeared.
More than seven years later, on June 17, 2020, the African American Tobacco Control Leadership Council and Action on Smoking and Health filed a lawsuit seeking to compel the FDA to act on the citizen petition. They were later joined by the National Medical Association and American Medical Association.
Last fall FDA notified AATLC and the other plaintiffs that the FDA would finally be responding to the 2013 citizen’s petition by January 29, 2021. (FDA did not bother to tell the actual petitioners, now the Tobacco Control Legal Consortium.) In response to this information, the Public Health Law Center together with 19 other health and medical groups submitted a detailed update of the overwhelming evidence that banning menthol would be appropriate for the protection of public health and addressing spurious arguments (like smuggling) that the industry was likely to use to oppose regulation. Everyone interested in menthol should read this very strong comprehensive submission.
While it was s good thing that the FDA was at least committing itself to respond, the timing suggested that the response would be controlled by the outgoing Trump Administration (which would be in office through January 20).
In order to give the new Biden Administration time to control the response, the plaintiffs and defendants agreed to extend the deadline for FDA to response to April 29, 2021 (legal documents 1 and 2). The Court approved this agreement.
What this means in practical terms is that the Biden Administration is now required to take a position on menthol cigarettes (and, by implication, menthol directly) in the next 3 months. The question is whether they will duck the issue as Obama did, or use this lawsuit to take meaningful action against menthol.
One encouraging sign is that California Attorney General Xavier Becerra, Biden’s nominee for Secretary of Health and Human Services, has been actively involved in enforcing the Master Settlement Agreement with the tobacco companies. More to the point, Becarra has signed letters together with other AGs urging FDA to include menthol in its enforcement against flavored e-cigarettes (something the FDA has not done) and providing FDA specific recommendations on how FDA could use its authority to control smuggling (another thing the FDA has not done).
While Becerra will certainly have his hands full when he takes over the Department, this is one area in which he has a strong background and pro-health record to protect him from bureaucratic manipulation from below and to defend strong action with the While House above.