Food and Drug Administration Commissioner Scott Gottlieb has dramatically escalated his efforts to stop an “epidemic” of teenage vaping, announcing Wednesday a massive enforcement action against retailers for allegedly selling e-cigarettes to minors and warning manufacturers of a potential ban of flavored e-cigarette liquids.
Officials said the move against more than 1,300 retailers was the largest coordinated enforcement action in the agency’s history. The threatened ban, if carried out, would significantly upend the fast-growing industry.
The latest data, not yet published, show a 75 percent increase in e-cigarette use among high school students this year compared to 2017. The FDA declined to publicly release the numbers, but people familiar with them said they were preliminary data from the National Youth Tobacco Survey, on which the agency and the Centers for Disease Control and Prevention collaborate.
In a speech to FDA employees, Gottlieb said that rapid spike in teen use, emerging sales trends and concerns among parents and teachers convinced him that underage use of e-cigarettes has become a full-blown crisis that must be forcefully addressed. “The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end,” he said.
In its enforcement action, the FDA recently sent almost 1,200 letters to brick-and-mortar stores and online retailers warning them that they could face penalties for allegedly selling e-cigarettes to people under 18. The agency also imposed fines — ranging from $279 to $11,182 — on another 130 establishments for repeated offenses.
Among those targeted were locations of Walgreens, Walmart, 7-Eleven, Circle K and Citgo and Exxon gas stations.
Even more significant, notices sent Wednesday morning demand that five leading e-cigarette manufacturers, including San Francisco-based Juul Labs, submit plans within 60 days detailing ways to sharply curb sales to underage consumers. If the blueprints don’t promise to “substantially reverse” the youth-use trend, Gottlieb said the agency will consider steps that could lead to the temporary or permanent removal of flavored products from the market.
Such a step would be a major blow to the e-cigarette companies — Juul, Vuse, Blu, Logic and MarkTen — which often feature cream and fruit flavorings in their products. Many public health groups believe such flavors entice young people to try the devices. The companies insist that the flavors are critical to helping nicotine-addicted adult smokers switch from conventional cigarettes.
Gottlieb’s action drew immediate praise from a major tobacco-control organization, the Campaign for Tobacco-Free Kids.
“This is potentially the most important step FDA has taken to curtail youth use of e-cigarettes,” said the group’s president, Matthew Myers. But this “fundamental turning point” will produce results only if the agency follows through by requiring all manufacturers to immediately undergo pre-market review at the FDA, he added.
Robin Koval, chief executive of Truth Initiative, urged fast follow-up to rein in the e-cigarette makers and cautioned against accepting any promises of voluntary action. “There’s no track record for this industry being able to police themselves on a voluntary basis,” she said.
The commissioner has repeatedly agreed that e-cigarettes can be an effective tool for adults trying to quit smoking, so his harsh words for the industry on Wednesday were all the more remarkable.
The Vapor Technology Association, a nonprofit with more than 600 industry members, called the move “a giant step backwards” that it blamed in part on “hysterical public health groups.”