The FDA has taken an initial step toward regulating — and possibly banning — the use of menthol in cigarettes.
On Tuesday, the agency issued an Advance Notice of Proposed Rulemaking, which requests information from the public regarding the effects of menthol in cigarettes and possible regulatory options. The comment period will last for 60 days before the FDA makes a decision. If a rule is ultimately proposed, there will be another comment period.
Accompanying the announcement was an FDA-authored, preliminary evaluation of the scientific evidence on the effects of menthol in cigarettes. The bulk of the evidence did not support an increase in toxicity or disease with the addition of menthol, although menthol was associated with increased initiation and greater progression to regular smoking, increased dependence, and reduced success in quitting, particularly among black smokers.
“These findings, combined with the evidence indicating that menthol’s cooling and anesthetic properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes,” the authors wrote.
Richard Hurt, MD, director of the Mayo Clinic’s Nicotine Dependence Center, said the evidence is clear that menthol — which makes tobacco smoke more palatable — helps people to start and continue smoking and makes it harder to stop.
“So in that respect it really serves no purpose in the cigarette except to do all of those things, and if you were to ask me the question, ‘Should we do away with menthol in cigarettes?,’ the answer is absolutely Yes,” Hurt said in an interview with MedPage Today.
Both Hurt’s and the FDA’s assessments are consistent with a 2011 report from the agency’s Tobacco Products Scientific Advisory Committee (TPSAC), which was formed after President Obama signed the Family Smoking Prevention and Tobacco Control Act into law in 2009.
That law amended the Federal Food, Drug, and Cosmetic Act to give the FDA the authority to regulate tobacco products. It banned candy- and fruit-flavored tobacco products, although it did not apply to products containing menthol.
In March 2011, the TPSAC submitted recommendations to the Secretary of the Department of Health and Human Services regarding menthol in cigarettes, with the conclusion that “removal of menthol cigarettes from the marketplace would benefit public health in the United States.”
At the same time, the nonvoting industry representatives from the committee submitted a separate report that concluded that “there is no scientific basis to support the regulation of menthol cigarettes any differently than nonmenthol cigarettes.”
Tobacco industry representatives were more restrained in their response to the FDA’s announcement on Tuesday.
A spokesperson for Altria, the parent company of Philip Morris USA, said in an email that the company is currently reviewing the situation and that it “will provide our perspective to the FDA through the public comment process.”
A spokesperson for the R.J. Reynolds Tobacco Company told MedPage Today that the company is reviewing documents related to the FDA’s action.
“We trust the agency will rely on sound science as it relates to the relative harm presented by various tobacco products when considering product regulations,” he said in an email.
For their part, health groups applauded the FDA’s initial step toward regulating menthol in cigarettes.
“For years, pediatricians have called for the elimination of all flavored tobacco products, including menthol. We know that candy and other flavors make tobacco products more attractive to children, and it’s time to stop manufacturing products that we know will lead many of today’s children to nicotine addiction, unnecessary illness, and premature death,” Thomas McInerny, MD, president of the American Academy of Pediatrics, said in a statement.
“Menthol and other flavors are dangerous in all tobacco products — whether in cigarettes, cigars, or other types of tobacco — and the FDA should act accordingly,” he said. “We urge the FDA to move forward swiftly with rulemaking to eliminate menthol and other flavors from all tobacco products.”
And Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a statement, “We hope the effort to invite public comment on the regulation of menthol cigarettes will only serve to strengthen the already compelling need to remove these products from the market, and to compel the FDA’s quick action.”
–Todd Neale, MedPage Today Senior Staff Writer