FDA Fails to Account for E-Cigarettes’ Health Benefits

Nevada Attorney General Catherine Cortez Masto joined 28 other state attorneys general last week in a letter supporting the Food and Drug Administration’s proposal to expand its regulatory umbrella over tobacco products to include electronic cigarettes. Unfortunately, the FDA jeopardizes public health by not adequately assessing the costs of suppressing the e-cigarette market.

The FDA errs on the side of assuming e-cigarettes pose more of a health risk than an opportunity to improve public health. Numerous studies, however, show that e-cigarettes help some smokers reduce or quit smoking. Studies also suggest that e-cigarettes are at least as effective, if not more, than FDA-approved nicotine replacement therapies such as patches, gums and pills. Their effectiveness appears to be related to how they mimic the act of smoking.

Federal regulators dismiss “harm reduction theory” — the theory that minimizing damage from risky behavior may promote public health more effectively than simply banning risky behavior. Such a model is in line with estimates that up to 98 percent of tobacco-related deaths are attributable to combustible products such as cigarettes, pipes and cigars.

The FDA downplays the possibility that noncombustible products such as e-cigarettes are substantially less dangerous than combustible tobacco products by claiming lack of evidence.

The American Medical Association may disagree. As AMA explains, e-cigarettes do not contain tobacco, the main reason regular cigarettes are so harmful. Moreover, vapor from e-cigarettes is much less toxic than secondhand tobacco smoke. And while e-cigarettes do contain nicotine, which is also not healthy, nicotine probably does not contribute nearly as much to smoking-related diseases as tobacco.

The proposed rule would impose labeling requirements and warning statements for packages and advertisements. However, public health will likely be harmed if manufacturers are prohibited from marketing their products as safer alternatives to tobacco cigarettes or even inform consumers that their products do not contain tobacco. The proposed regulation will push manufacturers to tout other factors — such as flavor, price, and convenience — thus steering manufacturers away from developing new products aimed at helping smokers reduce or quit smoking.

Unintended consequences abound. As the costs of bringing products to market rise, those costs will be passed on to consumers. Raising e-cigarette prices on smokers who are interested in quitting is unlikely to promote public health.

If manufacturers are unable to inform smokers that e-cigarettes are safer alternatives, the FDA may unwittingly promote tobacco use. The proposed rule thus weakens the creative destruction that the e-cigarette industry might otherwise exert on the tobacco industry.

There is evidence that smokers are interested in quitting, or at least want safer alternatives. A recent Gallup poll found that 74 percent of U.S. smokers want to quit. And one top tobacco analyst, Bonnie Herzog of Wells Fargo Securities, estimated e-cigarette sales in the United States topped $1.7 billion last year.

The Centers for Disease Control and Prevention estimates the annual costs attributed to smoking in the United States are between $289 billion and $333 billion. In light of these costs, the possibility that e-cigarettes represent a market response that fills the need for harm reduction by the 32.2 million smokers wanting to quit is worth pursuing.

This does not mean that the FDA should not regulate e-cigarettes. Prohibiting sales to youth and requiring a clear description of product ingredients may be appropriate. But prohibiting any information regarding potential harm reduction is hard to justify. The FDA needs to develop a regulatory strategy that fully considers the potential benefits of e-cigarettes and the unintended adverse effects on public health of stymieing the evolution of a promising harm-reduction tool.

In other words, the FDA should not remove the financial incentive to develop safer smoking products. Instead, it should foster a competitive market that empowers consumers to make wise decisions about what they choose to put in their bodies.