FDA

Vaping Regulation Threatens a Lifesaving Smoking Alternative

Policy makers are acting as if saving the lives of smokers via harm-reducing alternatives counts for nothing.

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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 rejecting any ENDS in flavors that are popular among teenagers, even when the main consumers are adults.

Survey data indicate that the vast majority of teenagers who vape regularly are current or former smokers. That means the FDA's fear that ENDS are causing an "epidemic" of adolescent nicotine addiction is overblown—especially since vaping by teenagers dropped substantially in 2019 and 2020, a development the agency prefers to ignore. There is even less reason to think vaping is a significant "gateway" to smoking among teenagers who otherwise never would have tried nicotine. If anything, recent trends suggest the availability of ENDS has accelerated the downward trend in adolescent smoking.

The folly of the obsession with preventing underage vaping was apparent in San Francisco, where a 2018 ban on flavored ENDS seems to have boosted smoking by teenagers and young adults. That cautionary example has not deterred other jurisdictions from considering the same counterproductive policy.

In case heavy-handed federal and local regulations are not enough to stop smokers from quitting, House Democrats have proposed excise taxes that would double or triple the retail price of e-liquids. "This tax will not only kill my business," a Georgia vape shop owner told Reason's Christian Britschgi. "It will kill Americans."

In an August American Journal of Public Health article, 15 prominent tobacco researchers warned that "policies intended to reduce adolescent vaping," including flavor bans, "may also reduce adult smokers' use of e-cigarettes in quit attempts." They emphasized that "the potential lifesaving benefits of e-cigarettes for adult smokers deserve attention equal to the risks to youths."

That article summarized "a growing body of evidence" that "vaping can foster smoking cessation." Yet Rep. Raja Krishnamoorthi (D–Ill.), who wrote a bill he called the END ENDS Act, insists "there's simply no evidence that vapes help [smokers] quit." He also claims to believe "adults can do what they want," which is likewise demonstrably false given the severe restrictions he favors.

Although the FDA acknowledges the harm-reducing potential of ENDS, in practice it is giving that benefit short shrift. Other policy makers, meanwhile, are proceeding as if the lives of smokers count for nothing.