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” as “tobacco products,” the industry remains in a legal vacuum, existing only because of the agency discretion in enforcement 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 as well, according to the agency, they will only be approved if manufacturers present ârobust,â âreliableâ and âproduct-specificâ evidence that their benefits help smokers quit.
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 ” risks and benefits to the population. in general.”
Under this highly subjective standard, imposed by the Family Smoking Prevention and Tobacco Control Act 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, meaning that the FDA’s fear that e-cigarettes are causing an ‘epidemic’ of nicotine addiction in teens is overwhelming. exaggerated. The same is true of the fear that vaping is a âgatewayâ to smoking among adolescents who otherwise would never have tried nicotine; on the contrary, recent trends suggest that the availability of electronic cigarettes has accelerated the downward trend in smoking among adolescents.
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,” a Georgia vape store owner told my Reason colleague Christian Britschgi, “it will kill 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 e-cigarettes, 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. Follow him on Twitter: @JacobSullum. To learn more about Jacob Sullum and read articles from other Creators Syndicate authors and designers, visit the Creators Syndicate webpage at www.creators.com.