March 19, 2011

Stanton A. Glantz, PhD

TPSAC gave the FDA what it needs to ban menthol

The FDA Tobacco Products Scientific Advisory Committee released its long-awaited menthol report yesterday, March 19, 2011.  The overall conclusions and recommendations in the report are on page 208 of the PDF.  There are two major scientific findings, repeated below (broken out into individual statements, but direct quotes, and one recommendation: "Removal of menthol cigarettes from the marketplace would benefit public health in the United States." The TPSAC reached this conclusion based on two more detailed important conclusions:

1. "Menthol cannot be considered merely a flavoring additive to tobacco. Its pharmacological actions reduce the harshness of smoke and the irritation from nicotine, and may increase the likelihood of nicotine addiction in adolescents and young adults who experiment with smoking."

2. "Furthermore, the distinct sensory characteristics of menthol may enhance the addictiveness of menthol cigarettes, which appears to be the case among youth. TPSAC has found that the availability of menthol cigarettes has adverse impact on public health by increasing the numbers of smokers with resulting premature death and avoidable morbidity."

Another very important scientific point in the report is that TPSAC recognized that menthol is more than an additive that modifies the taste of tobacco products.  It has a complex pharmacological interaction with nicotine that affects the addictive potential of cigarettes.

Had the committee stopped with its "overall recommendation to FDA" the message would have been unambiguous.  Unfortunately, the committee went on to add:


"The Act offers a variety of mechanisms for FDA to consider, if it concludes that it should pursue this recommendation. At this time, TPSAC has no specific suggestions for follow‐up by FDA to this recommendation."

I don't know why the TPSAC felt the need not to make a specific suggestion for follow-up; perhaps it was because they read their charge narrowly -- just to present a scientific conclusion -- but this sentence left the door wide open for the tobacco companies to spin the report as being weak because it did not recommend an outright ban of menthol.  (See, for example, the LA Times story.) 

This effort was so successful that tobacco stocks actually went up.

The reality is, of course, that despite the fact that the TPSAC did not explicitly recommend banning menthol, its conclusion that "removal of menthol would benefit public health" is precisely what the FDA needs to ban menthol.

Given the complex interaction of menthol with nicotine and the widespread use of menthol at subliminal levels (described in the report) anything short of an outright ban (such as banning its use as a "characterizing flavor") would leave the tobacco industry free to keep using menthol to hook kids and target minorities.  Given that the FDA is letting the cigarette companies get away with color coding packs to replace the banned descriptors "light" and "mild," one could easily imagine packs in various shades of green.

The cigarette companies are already thumping the tub of smuggling (a little booby trap that Philip Morris included in the bill; more). 

While TPSAC appropriately did not reach any conclusions about these smuggling claims (because there really isn't any good scientific evidence for them to use), they did note that there are 14,000,000 menthol smokers and expressed appropriate skepticism that all these people would engage in do-it-yourself mentholation.  TPSAC did note that if methol cigarettes became a black market good the price would go up, which would reduce consumption.

The same skepticism is warranted about whether 14,000,000 people would buy smuggled cigarettes.  At the very least it would be an easy task for law enforcement to find contraband of this huge magnitude. 

More important than speculation about smuggling, TPSAC noted that getting rid of menthol cigarettes would likely lead to a lot of people quitting smoking.  The report (on page 210) notes:

"The removal of menthol cigarettes from the market could result in a substantial reduction in cigarette smoking,  according to data from the May 2010 TUS‐CPS survey. The survey asked menthol smokers (N=2877), “If menthol cigarettes were no longer sold, which of the following would you most likely do?” According to analysis presented to TPSAC by Anne M. Hartman of the National Cancer Institute (January 2010), 39 percent of menthol smokers would quit, .... Her analysis included a breakdown of potential quitters by race/ethnicity, age and gender: among African American menthol smokers, (47 percent); among non‐Hispanic white menthol smokers ( 34 percent) ; among menthol smokers age 18–44 years ( 41 percent) ; among smokers age 45 years and over (37 percent); among female menthol smokers( 42 percent); and among male menthol smokers, (36 percent)."

This is a gigantic effect.  Even if it is off by a factor of 2, a menthol ban would have huge effects on public health.  

While the report was limited to menthol in cigarettes, all the same issues and conclusions apply to menthol in smokeless products (and e-cigs, for that matter).

The question at this point is whether the FDA and the Obama Administration will have the backbone to ban menthol in all tobacco products (or, at least as a first step, all smoked tobacco products, which is more than just cigarettes) and whether the major health organizations will unambiguously press for such a ban.









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