On July 24, 2013, the U.S. Food and Drug Administration issued an advance notice of proposed rulemaking (ANPRM) seeking comments from the public and other stakeholders on the potential regulation of menthol in cigarettes. Gottlieb and Daynard from PHAI submitted comments today on Docket No. FDA-2013-N-0521 calling on the Secretary of Health and Human Services to promulgate regulations to pursuant to her authority under sec. 906 of the Family Smoking Prevention and Tobacco Control Act to prohibit cigarette manufacturers from selling or distributing cigarettes that are:
a) Branded as a menthol product;
b) Marketed as a successor to a previously marketed menthol product; or
c) Otherwise likely to be perceived as a menthol product or menthol product successor in the marketplace.
The FDA\’s staff issued a peer-reviewed comprehensive scientific report as did the agency\’s Tobacco Products Scientific Advisory Committee in 2011. We noted that, \”these findings clearly establish an evidence base that justifies regulatory action by the Secretary to stop the harm to public health caused by permitting mentholated cigarettes to remain on the market. To put it simply, the most acute harm appears to be that mentholated cigarettes facilitate smoking initiation by youth, frustrate quit attempts by addicted smokers, and include brands that have particularly targeted African Americans in a way that amplifies health disparities.\”
Despite a years-long process, we are cautiously optimistic that FDA will move forward with regulations such as those we recommend in the near future.
View our comments here.