The FDA Wakes Up to the Danger of E-Cigarettes
(The Bloomberg View) -- Like a parent who's just caught the kids vaping in the backyard, the U.S. Food and Drug Administration has been jolted into realizing that electronic cigarettes are a problem. The agency's wake-up call came in the form of startling early data from the National Youth Tobacco Survey indicating that e-cigarette use among high school students is up more than 75 percent since last year, and among middle-schoolers by 50 percent.
FDA Commissioner Scott Gottlieb has warned Juul and the other leading e-cigarette companies that he means business when he says they need to keep their devices out of teenagers' hands. He accused the companies of so far treating the problem as a “public-relations challenge” rather than a serious legal and public-health concern.
The FDA is considering new limits on e-cigarette marketing, and threatens to take candy-flavored vapes off the market altogether. This is a most welcome change. But it still amounts to only a warning. The agency has to follow up with actions to regulate the manufacture, marketing and sales of electronic cigarettes as rigorously as it does the old-fashioned, combustible kind.
Until now, the FDA's approach to e-cigarettes has been too lenient. Last year, Gottlieb gave manufacturers an extra four years — until August 2022 — to apply for FDA approval, allowing all e-cigarettes that had been on the market as of August 2016 to continue to be sold with no controls on how they are made or marketed. Explaining this decision, Gottlieb pointed to the “potential benefits” of e-cigarettes to help smokers quit — even though their ability to do that is not established. On the contrary, as the commissioner now acknowledges, the evidence shows that teens who vape are much more likely than others to become smokers.
The agency has so far declined to impose any meaningful restrictions on candy flavorings or even the common-sense restrictions that are in place in European countries, such as limits on nicotine content. (Juuls in the U.K. contain only about a third as much nicotine as American Juuls have.) In the U.S., e-cigarettes are not even subject to the same constraints on TV and radio advertising that apply to regular cigarettes.
Gottlieb has given e-cigarette makers until mid-November to lay out plans to keep their products away from minors, including by refusing to sell to lax retailers and by eliminating candy flavors. But it would be a mistake to assume that voluntary actions will be enough, or that children are the only people at risk from e-cigarettes. The long-term health effects of vaping are uncertain for all users. Much more research is needed.
In the meantime, the FDA should require that e-cigarette packages list the quantities of all ingredients. It also needs to root out the many e-cigarettes that have come onto the market since August 2016 without FDA permission. Its failure to pay attention to this emboldened many new e-cigarettes to illegally capitalize on Juul's extraordinary popularity. The agency's recent letter to 21 manufacturers and importers is a step in the right direction.
Gottlieb and Secretary of Health and Human Services Alex Azar hold out hope that e-cigarettes can still be, for hardened smokers, a less-harmful alternative to burning tobacco. That remains to be seen. In the meantime, it's the FDA's responsibility to keep them away from kids and protect everyone from the health risks they pose.
Editorials are written by the Bloomberg View editorial board.
©2018 Bloomberg L.P.
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