Kudos to the FDA: E-Cigarettes Are Tobacco Products

On April 25, the FDA abandoned its claim that e-cigarettes are drug delivery devices. In an open letter published on the agency’s website (here), Tobacco Center Director Lawrence Deyton and Drug Center Director Janet Woodcock acknowledged that e-cigarettes are tobacco products and would be subject to regulations under the 2009 Tobacco Act. This is consistent with the January 2010 decision by federal judge Richard Leon (discussed here).

This is a victory on several counts for smokers and for our nation’s public health. First, the FDA decision guarantees that e-cigarettes, which have helped many smokers quit, will remain on the market.

Second, as the Deyton-Woodcock letter indicates, FDA regulation of e-cigarettes will subject them “to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for ‘new tobacco products’ and ‘modified risk tobacco products.’” These requirements will promote the marketing of safe and quality-controlled products.

Finally, this decision could allow pharmaceutical companies to reposition nicotine medicines as recreational alternatives to cigarettes. Today, these products are sold with a therapeutic claim for smoking cessation, but they are expensive, unsatisfying and FDA-approved only for temporary use (10-12 weeks). That accounts for their dismal success rate of only seven percent among smokers (evidence here). I believe pharmaceutical companies should enter the recreational nicotine market with products that satisfy smokers indefinitely and are cheap enough to compete directly with cigarettes. Clearly, the tobacco industry is poised to compete in this new market -- Reynolds American owns Niconovum (here) and British American Tobacco recently formed Nicoventures (here).

In my 1995 book “For Smokers Only” (description here), I shared my perspective on recreational nicotine for smokers:

“Smokers derive a lot of pleasure from smoking tobacco. You may be reading this book because you or your loved one actually enjoys lighting up a cigarette and taking several deep puffs. A smoke may be especially welcome when you are in a stressful situation or when you need to relax. Or you may enjoy smoking when you need to concentrate on a difficult problem at work or at home. Cigarette smoking can activate that mental pressure-relief valve, which is followed by the feeling that the problem can be solved, the crisis will pass. These feelings are real, and not just a figment of your imagination.

“Many tobacco opponents claim that these sensations are not truly pleasurable, but are merely the satisfying of induced cravings and avoidance of withdrawal symptoms. One of the big advantages of the smokeless tobacco solution is that it addresses either view of smoking equally well. That is, it doesn't matter if you are a smoker who is unwilling to quit because you enjoy tobacco, or if you are unable to quit because of nicotine craving and withdrawal. Because in either case you recognize the potential life-shortening effects of this nicotine delivery system. In either case the smokeless tobacco solution can work for you.”

Smoking has been the problem; smoke-free tobacco and nicotine can be the solution. In making the right call on e-cigarettes, the FDA has facilitated that solution.

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.

Misinformation from Three Senior FDA Officials

Many federal agencies deal with tobacco. For example, the Agriculture Department monitors tobacco cultivation (example here); the Treasury Department works with the Bureau of Alcohol, Tobacco and Firearms to monitor tax collections (example here); the Federal Trade Commission monitors sales and marketing (sample report here); and the Centers for Disease Control and Prevention tracks prevalence (sample here). In performing their functions, all these agencies distinguish cigarettes and smoking from smokeless tobacco and its use. Why doesn’t the Food and Drug Administration do the same?

Three senior FDA officials have authored a commentary about tobacco regulation for the New England Journal of Medicine (read it here) in which smoking and smokeless tobacco use are never distinguished. Even worse, “smoking” and “tobacco use” are used synonymously.

The FDA leaders are Lawrence Deyton, director of the Center for Tobacco Products, Joshua Sharfstein, principal deputy commissioner, and Margaret Hamburg, commissioner. They write, “Still, tobacco use causes more than 400,000 deaths in the United States annually…” This is just one of eight times in the article where Deyton et al. use the all-encompassing word “tobacco” when they are describing cigarettes or smoking.

Physician/authors Deyton, Sharfstein and Hamburg clearly are pursuing an agenda when they knowingly rely on “smoking” data but still describe “tobacco products” as “the leading cause of preventable death in the United States.”

Muddled terminology has been a hallmark of anti-tobacco extremists for many years, but it has become particularly apparent recently, as more Americans have become aware of the vastly lower health risks related to smokeless tobacco versus cigarettes. It’s all part of the demonization of tobacco users and manufacturers.

Deyton, Sharfstein and Hamburg write, “Although most Americans know that tobacco is harmful, few know specifically how damaging it is to the health of both smokers and nonsmokers.” Although this is a reference to second-hand smoke, it is also true that few Americans know that smokeless tobacco is vastly safer, and a government agency is partially to blame.

The CDC routinely publishes the exact number of deaths from smoking: the current annual estimate is 442,083. But the number of deaths due to smokeless tobacco use is nowhere to be found, despite the fact that the CDC and the American Cancer Society are in possession of the applicable data. Both organizations refuse to release an estimate or share the data with outside investigators.

Deyton et al. write about “tools” that the FDA will use “to ensure that advertising is truthful and not misleading,” in order to counter “tobacco-industry efforts to mislead the public about the safety of tobacco products.”

“Truthful and not misleading” are excellent criteria that should apply not only to the tobacco industry, but to federal agencies and officials charged with tobacco regulation and public health.