Wednesday, January 12, 2011

Scientific Evidence Supporting FDA Regulatory Action of Menthol Cigarettes: Essentially Nil

In March, the FDA Tobacco Products Scientific Advisory Committee (TPSAC) is scheduled to release recommendations for agency regulation of menthol cigarettes. This is a highly charged issue, racially, politically and legally. Additionally, the TPSAC recommendations and any subsequent regulations will be harbingers of the FDA’s future handling of smokeless tobacco and tobacco harm reduction.

Dr. Lawrence Deyton, director of the FDA Center for Tobacco Products, has stated that the FDA’s “objective is to use the best available science to develop and put into action effective public health strategies to reduce the enormous toll of illness and death caused by tobacco products.” (here)

Last year, the “best available science” on menthol was reviewed by the American Council on Science and Health, a science-driven organization that has been anti-smoking for decades. I was an expert reviewer of that report (available here), which concluded that any differences in health effects from smoking menthol versus non-menthol cigarettes are inconsequential.

The ACSH report used the available scientific evidence to answer a series of questions:

1. Does cigarette mentholation affect initiation, dependency, and cessation?

ACSH: “Overall, the evidence summarized in this section does not suggest that mentholated cigarettes are associated with any independent reduction in age of starting to smoke (‘starter product for youth’), increase in cigarette consumption or dependency (‘greater addiction potential’)… Data from the Federal Trade Commission in 2006 indicate that the menthol percentage of the total cigarette market has been remarkably stable over the last 35 years. If menthol cigarettes were more addictive than non-menthol, or otherwise increased likelihood of usage, then menthol’s share of market would have steadily increased over the last 35 years.”

2. Does mentholation affect the metabolism and clearance of nicotine and other smoke constituents?

ACSH: “Although there are only a few studies, cigarette mentholation does not appear to have any major effects on either the absorption of nicotine and smoke, or the metabolism and elimination of tobacco smoke constituents.”

3. Does cigarette mentholation affect smoking behavior?

ACSH: “Taken as a whole, the data presented here are inconsistent with the idea that mentholation may affect how a cigarette is smoked so as to increase uptake of toxic smoke constituents through a ‘unique stimulatory sensation.’”

4. Could menthol cigarettes be claimed [by manufacturers] to be “healthier”

ACSH: “Any such health claims without rigorous substantiation would instantly attract the attention of numerous regulatory authorities, such as the Federal Trade Commission. Since these authorities have continued for decades to allow the sale of mentholated cigarettes, it is safe to assume that mentholated cigarettes do not differ in any substantial way from non-mentholated cigarettes in terms of generalized health claims.”

5. Does mentholation of cigarettes affect other smoke constituents, and is the subsequent toxicology any different?

ACSH: “The in vitro and in vivo toxicological properties of mentholated and non-mentholated cigarettes appear to be virtually identical.”

6. Does menthol affect airway patency?

ACSH: “…[M]enthol does not ‘help the poison go down,’ since if this were the case there would be substantial increases in the various biomarkers of smoke exposure, which is clearly not the case.”

7. Does mentholation increase the risk of lung cancer in smokers?

ACSH: “It appears to be very unlikely from the cumulative evidence that cigarette mentholation increases the risk of lung cancer, and may even protect from it.”

8. Does mentholation increase the risk of other diseases?

ACSH: “Overall, available epidemiological data on cancers other than lung cancer do not suggest any important pathogenic role of cigarette mentholation…Incidences of other diseases do not seem to differ between smokers of mentholated and non-mentholated cigarettes, and mortality rates are similar.”

The ACSH report also comments on the societal consequences of a menthol cigarette ban:

“An FDA ban of menthol in cigarettes would affect 25% of the near 50 million U.S. smokers. The affected smokers are largely minorities who have a strong preference for mentholation, and the arbitrary removal of this choice by the FDA would almost certainly result in the rapid establishment of a black market, possibly accompanied by ‘do-it-yourself’ attempts to modify non-menthol cigarettes through potentially more risky attempts at ‘home mentholation.’ Neither of these scenarios represents the actions of a society dedicated to the factual, unbiased, and scientific assessment of the biological effects of consumer products.”

The bottom line: There is essentially no published scientific evidence for any FDA regulatory action that restricts or removes menthol cigarettes from the American market.

No comments: