Legislation introduced recently by Reps. Tom Cole, R-Okla., and Sanford Bishop, D-Ga., would make significant changes to the way the Food and Drug Administration regulates tobacco and nicotine products. These changes should be welcomed as a necessary corrective. If the purpose of tobacco control is to reduce tobacco-related addiction, illness and death, the FDA’s current regulatory process may be off course.

Last August, the FDA “deemed” liquid-nicotine products—e-cigarettes and other “vaping” products—to be covered under the Tobacco Control Act of 2009, subjecting any that weren’t on the market before Feb. 15, 2007 to a costly two-year approval process. Those that don’t pass, or can’t afford to comply, with the new rules will be ordered to be pulled from shelves. The Cole-Bishop legislation would change that “grandfather” date and streamline the approval process significantly.

Doctors and scientists have known for decades that smokers smoke for the nicotine, but die from the tar. We also know, and have known for decades, that while cigarette smoke is highly addictive, plain nicotine is not. In fact, the public-health community long has recommended plain nicotine in the form of patches, gums and lozenges to treat addiction to cigarettes.

The scientific literature on tobacco-related issues also long has made clear that the smokeless tobacco products available on the American market pose far less risk than cigarettes. The allegation that smokeless tobacco is a major cause of mouth and throat cancer is based entirely on data, primarily from India, from products known as gutkha and pan masala. These products are complex mixtures of various herbs and spices, with tobacco being an optional ingredient. They are often made in primitive and unsanitary conditions. They bear little resemblance to the chewing tobacco, snuff and other smokeless products on the American market.

In other words, what determines tobacco-related addiction and risk is the class of tobacco product. Cigarettes are the most hazardous and most addictive products, while other combustible products like cigars and pipes pose intermediate risks. Smokeless and nicotine-only products like e-cigarettes pose far less risk, are less likely to cause life-long addiction, and are easier to quit.

Unfortunately, the Tobacco Control Act of 2009 dismissed the possibility that smokeless tobacco products might be less hazardous than cigarettes. Instead, the law promoted the idea that one can tell the risk and addictiveness of a tobacco product by looking at its chemical profile without regard to whether it is combusted, smokeless, or nicotine-only.

The epidemiologic literature—that is, based on studying human populations, not solely laboratory tests—provides unmistakably clear guidance as to levels of risk provided by each class of tobacco product.  At least for those products available in the United States, there is no scientific literature or survey data showing that any product is more or less hazardous than any other within its class.

Unfortunately, we have no idea how much of the illness and addictiveness of cigarette smoke is due to any specific chemical substance in cigarette smoke, and we have no realistic way to find out.  The only study I am aware of that explores this possibility concluded that the most prominent and most referenced carcinogens in cigarette smoke account for only about 4 percent of the risk.  Thus, as best we can tell, totally eliminating nitrosamines, benzene, and other prominent carcinogens in cigarette smoke would likely result in little or no measurable decrease in cigarette-related illness and death.

Even if it did, proving the benefits from that sort of chemical manipulation likely would require a case-control study in which several thousand non-smokers would be recruited to smoke at least a pack a day of a conventional cigarette for 15 to 20 years and a similar number of non-smokers would be recruited to smoke the supposedly safer cigarette for a similar period. For both practical and ethical reasons, such an experiment can never be done.

Fortunately, we do not need that sort of experiment to protect public health.

We know that smokers can reduce their risk of potentially fatal cigarette-related disease by 95 percent or more by switching to a smokeless or nicotine-only product like an e-cigarette or one of the pharmaceutical gums or patches. Not only that, we have substantial scientific evidence and practical experience to show that these products are far less addictive than cigarettes and, as such, easier to quit and with less propensity to recruit teens to long-term use.

If done properly, encouraging smokers to switch to lower-risk products—a strategy known as “tobacco harm reduction”—could reduce tobacco-related addiction, illness, and death to very low levels and do so at little or no cost to taxpayers, with no coercive measures needed and no chemical manipulation of existing tobacco products.  As best we can tell, our experience to date with e-cigarettes has been associated with record low levels of teen and adult smoking and significant improvements in the health of COPD patients who have switched from smoking to vaping.

Further reducing cigarette consumption likely will require honest communication by public authorities about the relative risks of cigarettes versus smokeless products and e-cigarettes, and sensible federal regulation to keep poorly made and contraband products off the market. Fiddling with the chemical profile of existing tobacco-related products is unlikely to help.

As is the custom for regulation of the safety of foods, beverages, and other consumer products, the regulatory process should be designed to deal with the product’s quality and consistency, not to eliminate novel and relatively low-risk products from the market by making the requirements so expensive that only the largest corporations can afford to comply.

The current FDA regulatory process protects major-brand cigarettes and pharmaceutical gums and patches from competition from smokeless and e-cig products, but does nothing to protect public health. If the FDA can’t find a way to better conform its regulatory efforts to that goal, modifying the Tobacco Control Act might be in order.


Image by DEJAWOO