VAPING REGULATION THREATENS A LIFESAVING SMOKING ALTERNATIVE.

AuthorSullum, Jacob
PositionDRUGS

ELECTRONIC CIGARETTES, WHICH deliver nicotine without tobacco or combustion, are the most important harm-reducing alternative to smoking ever developed, one that could prevent millions of premature deaths in the U.S. alone. Yet bureaucrats and politicians seem determined to negate that historic opportunity through regulations and taxes that threaten to cripple the industry.

In October, seven years after the Food and Drug Administration (FDA) officially declared its intention to regulate "electronic nicotine delivery systems" (ENDS), the agency finally approved one such product. But the FDA, which has rejected applications for millions of other vaping products, still seems inclined to ban the e-liquid flavors that former smokers overwhelmingly prefer. Why? Because teenagers also like them.

The FDA authorized the marketing of R.J. Reynolds Vapor Company's Vuse Solo device, along with two tobacco-flavored cartridges. It said the company had presented enough evidence to conclude that the products "could benefit addicted adult smokers" by "reducing their exposure to harmful chemicals." But at the same time, the FDA rejected 10 applications for Vuse Solo cartridges in other flavors.

According to survey data, three-quarters of adult vapers prefer flavors other than tobacco. But because those flavors also appeal to teenagers, the FDA says, they will be approved only if manufacturers present "robust," "reliable," and "product-specific" evidence that their benefits in helping smokers quit outweigh the risk that they will encourage underage vaping.

R.J. Reynolds, whose Vuse products account for nearly a third of the ENDS market, is a large company that had the resources to conduct the sort of expensive research demanded by the FDA. The fact that it was nevertheless unable to overcome the agency's bias against flavored ENDS did not bode well for other manufacturers or for consumers who value variety.

Under federal law, the FDA is supposed to decide whether approving a vaping product is "appropriate for the protection of public health," taking into account "the risks and benefits to the population as a whole." While that collectivist calculus is both morally dubious and highly subjective, it at least suggests that the FDA is expected to weigh the benefits of flavored e-liquids, measured in smoking-related death and disease these products could help prevent, against the costs of the underage vaping they might encourage. Instead, the FDA seems bent on...

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