Vaping Is Risky. Why Is the F.D.A. Authorizing E-Cigarettes?


When they first appeared in the United States in the mid-2000s, “electronic nicotine delivery systems” — e-cigarettes, vapes, e-liquids and other wares that contain the stimulant found in tobacco — were subject to little federal oversight. Their makers could incorporate countless other ingredients and flavorings. Like cigarettes before them, the devices proved extremely attractive to young people; in 2018, the surgeon general declared youth vaping an “epidemic” and noted that one in five high schoolers and one in 20 middle schoolers used e-cigarettes. Nicotine can harm the developing brain, and e-cigarettes contain potentially harmful toxins like heavy metals; the long-term effects of vaping — the heating of nicotine to create an inhaled aerosol — are uncertain.

Despite these concerns, public-​health officials in the U.S. hope that, given a choice in the open market, people already addicted to nicotine will choose e-cigarettes over cigarettes — a deadly consumer product so successful at attracting and retaining users that it has killed as many as 24 million Americans over the past six decades. Because e-cigarettes generally contain fewer toxic chemicals than tobacco smoke, they are believed to be less damaging than cigarettes. If a sizable number of the one in seven adults in the U.S. who smoke switched to e-cigarettes, the theory goes, significantly fewer people might suffer from cancer and cardiovascular and respiratory diseases.

In 2016, in an effort to mitigate the potential harms of e-cigarettes, the Food and Drug Administration began regulating them as “new tobacco products.” It became illegal to sell e-cigarettes to anyone under 18 (a cutoff that rose nationally to 21 in late 2019), and the agency was empowered to require warning labels. The F.D.A. also gained the authority to keep products out of the marketplace, unless it could be demonstrated that their public-health benefit outweighed their risks. (As a result of legislation passed in 2009, this condition applies to new tobacco products in general; cigarettes themselves, and other tobacco products on the market before Feb. 15, 2007, don’t have to meet the same standard.) As of last month, the agency had denied nearly a million applications. But a vaporizer and two liquids, in regular tobacco and menthol flavors, were authorized, after the F.D.A. declared that data submitted by their manufacturer showed that they were indeed less toxic than cigarettes and could, in the words of the agency’s news release, “benefit addicted adult smokers who switch to these products.” This would “outweigh the risk to youth” and lead to an overall “protection of the public health.”

The decision was controversial. In part, this is because the research into whether e-products can help adult smokers stay off cigarettes shows mixed results at best. For example, in October, the same month as the F.D.A. ruling, JAMA Network Open published a study that “did not find evidence that switching to e-cigarettes prevented relapse to cigarette smoking,” says the lead author John P. Pierce, a emeritus professor at the Herbert Wertheim School of Public Health and Human Longevity Science at the University of California, San Diego. He and his colleagues analyzed data from the Population Assessment of Tobacco and Health Study, a longitudinal study of tobacco use in the U.S. begun in 2013 by the National Institutes of Health and the F.D.A. Based on responses through 2017, the researchers identified 13,604 participants who were cigarette smokers. When those same participants were surveyed a year later, 9.4 percent of them reported that they had quit.



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