FDA regulatory expansion jeopardizes public health

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In August, the U.S. Food and Drug Administration has proposed expanding its regulatory authority over tobacco products to include cigars, pipe tobacco, hookah tobacco, electronic cigarettes (e-cigarettes), and dissolvable products and gels. Currently, cigars are the most popular item in this group, but e-cigarette use is rapidly expanding.

E-cigarettes are battery-powered  nicotine delivery systems, simulating  tobacco smoking by producing a water-vapor plume resembling smoke. New regulations would require product registration, standardized listings of ingredients, government pre-approval of new products, labeling requirements, and prohibitions against providing free samples to consumers.

First, Do No Harm

By implicitly dismissing harm reduction theory, the FDA jeopardizes its own public health goals. ???Harm reduction??? is a policy concept suggesting that minimizing the damage incurred from risky behaviors more effectively promotes public health than seeking the outright elimination of the behavior.

Up to 98 percent of tobacco-related deaths are attributable to cigarettes, pipes, and cigars, but the FDA downplays the possibility that e-cigarettes are less dangerous than combustible tobacco products.

The American Medical Association published a ???Patient Page??? fact sheet in January 2014, stating that e-cigarettes??? lack of tobacco is the reason why e-cig ???vapor is much less toxic than secondhand tobacco smoke.??? Instead of using new technology as an opportunity to improve the public???s health, the FDA errs by assuming e-cigarettes pose more of a health risk than traditional tobacco products.

Available evidence indicates that e-cigarettes help some smokers reduce or quit smoking, with success rates reported between 7 and 20 percent of smokers attemping to quit smoking using e-cigarettes.

It is troubling that these studies are not discussed by the FDA, and especially unfortunate for 32 million smokers who tell pollsters that they want to kick the habit.

Creative Destruction

The FDA???s proposed rule would slow development of the e-cigarette market by prohibiting manufacturers from marketing e-cigarettes as safer than cigarettes. Federal health regulators also prohibit manufacturers from informing consumers that such products do not contain tobacco.

In effect, the proposed rule removes much of the profit from developing safer and more effective harm-reduction products, redirecting resources toward attributes???such as color, taste and packaging???unrelated to improved public health. Traditional tobacco companies may be helped by the regulations, as the proposed rule weakens the creative destruction otherwise exerted upon the tobacco industry by the competing e-cigarette industry.

Prohibiting sales to youth and requiring a clear description of product ingredients may be appropriate, but prohibiting any information regarding potential efficacy in harm reduction is hard to justify, given substantial benefits reported in currently available studies.

The FDA needs to consider fill the potential benefits of e-cigarettes, as well as the many unintended adverse effects on public health caused by regulatory discouragement of market innovations.

Michael L. Marlow ( is a professor of economics at California Polytechnic State University.


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