Tag Archives: Menthol

After FDA’s Menthol Announcement, PHAI’s Gottlieb and Daynard Consider Next Steps


In an op-ed published today in the Boston Globe, a day in which FDA announced it’s intention to issue regulations to ban menthol cigarettes, PHAI’s executive director and president consider what the next steps in tobacco prevention should be.

Gottlieb and Daynard suggest that:

  1. The FDA should also remove menthol flavored e-cigarettes from the market.  If these products, favored by youth, are on the market to help menthol smokers switch to e-cigarettes, this will not be necessary once menthol cigarettes are gone.
  2. Nicotine must be carefully regulated so that cigarettes are no longer addictive.  The evidence is that very low nicotine cigarettes will help smokers to quit and will not result in them increasing smoking to compensate.
  3. The nicotine strength in American e-cigarettes is more than double the maximum allowed in Europe.  There is no public health rationale for e-cigarettes to be this addictive and the FDA should regulate them accordingly.
  4. Finally, the end of the public health crisis caused by tobacco industry products will only come when we plan to phase out their sales entirely to establish a tobacco-free generation.  Brookline, Massachusetts is the first community in the nation to approve this policy and is poised to prohibit sales of any tobacco products to anyone born on or before January 1, 2000. This slow phase-out is a reasonable and permanent way sunset these lethal and addictive products permanently. It should be widely adopted.

PHAI urges FDA to prohibit the sale and distribution of menthol cigarettes

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.