FDA Regulatory Expansion Jeopardizes Public Health

Published November 10, 2014

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.

New regulations would require product registration, standardized listings of ingredients, government preapproval of new products, labeling requirements, and prohibitions against providing free samples to consumers.

First, Do No Regulatory Harm

By implicitly dismissing harm reduction policy, the FDA is jeopardizing 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 e-cigarettes are less dangerous than combustible tobacco products.

The American Medical Association published a “Patient Page” fact sheet in January 2014, stating 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.

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

Regs Would Weaken Competition

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 already 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. The regulations may help traditional tobacco companies, as the proposed rule weakens the creative destruction otherwise exerted upon the tobacco industry by the competing e-cigarette industry.

Prohibiting sales to youths 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 the substantial benefits reported in scientific studies.

The FDA should fully consider 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 ([email protected]) is a professor of economics at California Polytechnic State University.

Internet Info:

“Regulating a Less Unhealthy Cigarette,” Michael L. Marlow, Cato Institute: http://heartland.org/policy-documents/regulating-less-unhealthy-cigarette/