Support for cigarette menthol ban and cigar flavor ban; need to ban menthol as an ingredient not just as a characterizing flavor and to eliminate exceptions for some tobacco products (Statement at June 13, 2022 FDA Listening Session)

My name is Stanton Glantz.  I am a retired Professor of Medicine at the University of California San Francisco and was the principal investigator of the UCSF Tobacco Center of Regulatory Science.

The FDA did an excellent job of summarizing the science on the effects of menthol to build a justification for ending the use of menthol in cigarettes.  In particular, FDA pointed out that the effects of menthol go well beyond its use as a characterizing flavor to interact with nicotine at the level of brain receptors in a way that makes nicotine more addictive, particularly to the developing brain.

Specifically, FDA reported:

In addition to its flavor and sensory effects, menthol contributes to a greater risk of nicotine dependence by enhancing the addictive effects of nicotine in the brain by affecting mechanisms involved in nicotine addiction (Refs. 10-13).  Clinical data show that menthol cigarette smokers have higher levels of brain nicotinic receptors compared to non-menthol smokers (Ref. 14). Studies demonstrate that menthol, like nicotine, binds to nicotinic receptors in the brain (Refs. 15 and 16), and menthol alone can increase the number of nicotinic receptors in the brain (Refs. 10 and 11). Evidence demonstrates that the combined effects of menthol and nicotine in the brain are associated with behaviors indicative of greater addiction to nicotine compared to nicotine alone (Refs. 10 and 12).  (Page 11)

Indeed, there is industry research showing that menthol can be “tuned” to compensate for lowered nicotine levels.[1] 

Not only does this justify FDA moving forward with the proposed rule, but it highlights the need to strengthen the rule in two ways:

First, FDA should prohibit menthol (and menthol analogs) as ingredients not just as a characterizing flavor.  Under the rule as proposed tobacco companies could continue to add menthol to cigarettes to maximize their addictiveness if they simply stopped calling them “menthol cigarettes.”

This is also important because menthol is an important ingredient in many “non-menthol” cigarettes, precisely to increase addictiveness, as the FDA so clearly described in the proposed rule.

Second, FDA should drop the proposed exemption for low nicotine cigarettes and heated tobacco products.  The effects of menthol on the brain and its interaction with nicotine the FDA describes have nothing to do with combustion.  Menthol and menthol analogs should be prohibited in all tobacco products for precisely the same reasons FDA proposes to prohibit menthol in cigarettes.

For the same reasons, I also support the proposed cigar rule.

In the proposed cigar rule FDA asked for comment on whether waterpipe and pipe tobacco should be included.  The answer is yes.  The effects of menthol and its interaction with nicotine depend on chemistry and biological effects that have nothing to do with the product used to develop the mixture to the brain.

Indeed, because of the fundamental interaction of menthol and nicotine, menthol and menthol analogs should be prohibited as ingredients in all tobacco products.

Thank you.

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[1] Yerger VB. Menthol’s potential effects on nicotine dependence: a tobacco industry perspective. Tob Control. 2011 May;20 Suppl 2(Suppl_2):ii29-36. doi: 10.1136/tc.2010.041970. PMID: 21504929; PMCID: PMC3088468.

Yerger VB, McCandless PM. Menthol sensory qualities and smoking topography: a review of tobacco industry documents. Tob Control. 2011 May;20 Suppl 2(Suppl_2):ii37-43. doi: 10.1136/tc.2010.041988. PMID: 21504930; PMCID: PMC3088462.