Flavored e-cigarettes are said to be a tool that helps adults quit smoking traditional cigarettes, the main example of a plus the product can claim.
The agency is giving e-cigarette companies 60 days to come up with a plan for reducing use of their products among minors.
It recognized the impact this might have on the use of these products by adults trying to stop smoking, but said that emerging research shows that action must be taken. "Hindsight, and the data that's now available to us, fully reveal these trends".
The appeal of e-cigarettes to teens is widespread and has raised alarms in other countries, including the UK. But it also sent letters to five leading manufacturers of "electronic nicotine delivery systems" (ENDS), insisting that they do more to keep their products away from teenagers.
Of the 3.6 million middle- and high-school students who said in 2017 they are current tobacco-product users, 2.1 million used e-cigarettes, according to the Centers for Disease Control and Prevention. They noted the survey did not ask specifically about Juul, a sleek, heavily-marketed e-cigarette brand that exploded onto the market and accounts for 70 percent of US sales, according to analyst estimates. The FDA's delay on that requirement has allowed the industry to flourish with little oversight. The FDA is demanding what Gottlieb describes as "plans to immediately and substantially reverse" the "clear and present danger" of adolescent vaping.
It will also "re-visit" the policy it announced a year ago, which gave e-cigarette companies more time to apply for regulatory approval.
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"Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes", Juul said in a statement. "By working together, we believe we can help adult smokers while preventing access to minors, and we will continue to engage with the FDA to fulfill our mission". Regulators said it was the largest coordinated crackdown in the agency's history.
The FDA discovered that top-selling brands like JUUL, Vuse, MarkTen XL, blu e-cigs, and Logic were popular among minors. We think right now we can step into this market with a combination of enforcement actions against the places that we know kids are getting access to these products, which includes retail establishments that are selling them without putting proper restrictions in place or without carding minors, as well as the online sites, where we think that there are a straw purchases being made, where - where someone's going online, buying a lot of these products, and then reselling them to kids.
The FDA is in the process of rolling out a sweeping anti-smoking initiative created to make it easier for smokers to quit by cutting the nicotine levels in regular cigarettes.
E-cigarettes are battery-powered devices that heat a nicotine liquid into a vapor that can be inhaled.
On Wednesday, Gottlieb criticized e-cigarette companies' handling of the underage use problem, saying they approached it as "a public relations challenge rather than seriously considering their legal obligations".
Many use fruit- or candy-flavored liquids that critics say appeal to kids, and risk addicting them to nicotine.