Bureaucrats and politicians appear determined to cripple vital alternative to smoking | Sullum


Electronic cigarettes, which deliver nicotine without tobacco or combustion, are the most important harm reduction alternative to smoking ever developed, an alternative that could prevent millions of premature deaths in the United States alone.

Yet bureaucrats and politicians seem determined to deny this historic opportunity through regulations and taxes that threaten to cripple the industry.

When a court-set deadline for ‘pre-market’ approval of vaping products arrived and passed on September 9, the Food and Drug Administration had received millions of applications but had not approved any. none. As a result, according to the agency, every vaping device and nicotine liquid sold in the United States is “illegally marketed” and “subject to enforcement action at the discretion of the FDA.”

Seven years after the FDA officially declared its intention to regulate “electronic nicotine delivery systems” (ENDS) as “tobacco products,” the industry remains in a legal limbo, only existing thanks to agency discretion and limited resources. Despite the FDA’s promises of regulatory flexibility, it perpetuates a situation where manufacturers are unsure whether they will still be in business next week, next month, or next year.

The FDA has rejected millions of requests for nicotine liquids in non-tobacco flavors, which are the products ex-smokers overwhelmingly prefer. Because these flavors appeal to teens too, according to the agency, they will only be approved if manufacturers present “robust,” “reliable” and “product-specific” evidence that their benefits in helping smokers quit outweigh. on the risk that they encourage underage vaping. .

No one really knows what this means, although the FDA says that “the evidence of benefits for adult smokers for such products would likely be in the form of a randomized controlled trial or a longitudinal cohort study.” Such research is beyond the means of all but the largest companies, and even they may find it difficult to persuade the FDA that approval of their products is “appropriate for the protection of public health,” taking into account ” of risks and benefits to the population as a whole. “

Under this highly subjective standard, which is mandated by the Family Smoking and Tobacco Control Act of 2009, it is not enough for a manufacturer to show that their products are much safer than conventional cigarettes. It is also not enough to show that flavors other than tobacco are extremely popular among former smokers, as the FDA could still conclude, even implausibly, that the risk of underage consumption outweighs the well-being. smokers interested in switching to vaping.

Survey data indicates that the vast majority of teens who vape regularly are current or former smokers, which means the FDA’s fear that ENDS is causing an ‘epidemic’ of nicotine addiction in teens is exaggerated. . The same is true of the fear that vaping is a “gateway” to smoking among adolescents who otherwise would never have tried nicotine; If anything, recent trends suggest, the availability of NDT has accelerated the downward trend in smoking among adolescents.

The craziness of the obsession with preventing vaping among minors was apparent in San Francisco, where the ban on flavored ENDS appears to have boosted smoking among teens and young adults. This edifying example has not deterred other jurisdictions from considering the same counterproductive policy.

In case strict federal and local regulations weren’t 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,” told my Raison colleague Christian Britschgi. “It will kill the Americans.”

Last month, in the American Journal of Public Health, 15 leading tobacco researchers warned that “policies to reduce teen vaping may also reduce e-cigarette use by adult smokers in attempts to ‘stop”. They stressed that “the potential benefits of electronic cigarettes for adult smokers deserve equal attention to the risks for young people.”

Although the FDA recognizes the harm reduction potential of ENDS, in practice it places little weight on this benefit. Other decision-makers, on the other hand, act as if the lives of smokers count for nothing.

Jacob Sullum is editor-in-chief at Reason magazine.

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