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 United States alone. Yet bureaucrats and politicians seem determined to negate that historic opportunity through regulations and taxes that threaten to cripple the industry.
When a court-set deadline for “premarket” approval of vaping products came and went on Sept. 9, the Food and Drug Administration had received millions of applications but had not approved any. As a result, the agency says, every vaping device and nicotine liquid sold in the U.S. is “marketed unlawfully” and “subject to enforcement action at the FDA’s discretion.”
Seven years after the FDA officially declared its intention to regulate “electronic nicotine delivery systems” as “tobacco products,” the industry remains in legal limbo, existing only because of the agency’s enforcement discretion and limited resources. Despite the FDA’s promises of regulatory flexibility, it is perpetuating a situation in which manufacturers don’t know whether they will still be in business next week, next month or next year.
The FDA has rejected millions of applications for nicotine liquids in flavors other than tobacco, which are the products that former smokers overwhelmingly prefer. Because those flavors also appeal to teenagers, the agency 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.
No one really knows what that means, although the FDA says “the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study.” Such research is beyond the means of all but the largest companies, and even they may have trouble persuading the FDA that approval of their products is “appropriate for the protection of the public health,” taking into account “the risks and benefits to the population as a whole.”
Under that highly subjective standard, which is mandated by the Family Smoking Prevention and Tobacco Control Act of 2009, it is not enough for a manufacturer to show its products are far less hazardous than conventional cigarettes. Nor is it enough to show that nontobacco flavors are enormously popular among former smokers because the FDA might still conclude, however implausibly, that the risk of underage consumption outweighs the welfare of smokers interested in making the potentially lifesaving switch to vaping.
Survey data indicates that the vast majority of teenagers who vape regularly are current or former smokers, which means the FDA’s fear that e-cigarettes are causing an “epidemic” of adolescent nicotine addiction is overblown. So is the fear that vaping is a “gateway” to smoking among teenagers who otherwise never would have tried nicotine; if anything, recent trends suggest, the availability of e-cigarettes has accelerated the downward trend in adolescent smoking.
The folly of the obsession with preventing underage vaping was apparent in San Francisco, where a ban on flavored e-cigarettes seemed 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 price of e-liquids. “This tax will not only kill my business,” a Georgia vape shop owner told my Reason colleague Christian Britschgi, “it will kill Americans.”
Last month in the American Journal of Public Health, 15 prominent tobacco researchers warned that “policies intended to reduce adolescent vaping 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.”
Although the FDA acknowledges the harm-reducing potential of e-cigarettes, in practice, it is giving that benefit short shrift. Other policymakers, meanwhile, are proceeding as if the lives of smokers count for nothing.
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