Federal Regulation of Menthol Tobacco Products

Tobacco companies add flavors to their products to mask the harsh taste of tobacco, making it easier for young people to start smoking. That’s why Congress banned the sale of flavored cigarettes in 2009. But Congress made one exception to the flavor ban, deferring action on the most popular of all flavors — menthol — and directing the U.S. Food and Drug Administration to decide whether continued sale of menthol cigarettes is “appropriate for public health.”

To ensure that the FDA was advised about menthol and other scientific issues, the Tobacco Control Act established the Tobacco Products Scientific Advisory Committee (TPSAC), which included leading scientific experts, and mandated that the Committee study menthol in cigarettes. After a careful review of the evidence, the Committee issued its report in March 2011, concluding: “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.”

On April 12, 2013, twenty leading national organizations filed a formal Citizen Petition, urging the FDA to exercise its regulatory power, and to protect America’s health by prohibiting menthol as a characterizing flavoring in cigarettes. More than 1,000 public comments were submitted to the FDA on the Citizen Petition docket.

On July 23, 2013, more than two years after receiving the TPSAC report on menthol, the FDA issued an Advanced Notice of Proposed Rulemaking (ANPRM) seeking additional information on menthol in cigarettes. The FDA also released its preliminary scientific evaluation of public health issues related to the use of menthol in cigarettes. More than 174,400 public comments were submitted to the FDA on this docket.

The FDA’s consideration of the problem of menthol has been shadowed by tobacco industry litigation. Led by Lorillard, the tobacco industry sued the FDA in 2011 in an attempt to prevent the agency from acting on the TPSAC report. In the lawsuit, the tobacco companies alleged that several experts the FDA appointed to the committee were biased and therefore must be removed. A district court judge sympathetic to the tobacco industry, U.S. District Judge Robert J. Leon, ordered the FDA to disregard TPSAC reports and findings issued while those experts were part of the committee. The FDA appealed that ruling.

In January 2016, the appellate court reversed Judge Leon's earlier decision, making it possible for the FDA to use the TPSAC report to take action to regulate menthol tobacco products. That litigation is still pending; read more about that decision on our blog.


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