In the US, about 12 percent of high school students use e-cigarettes at least once a month, the US Centers for Disease Control and Protection estimated in 2017.
"I've been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends", he said.
It marks a shift in the agency's tone on e-cigarettes.
In a statement, Juul Labs said "appropriate flavors" play a role in adults changing their smoking habits, but said it would work with the FDA: "We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people".
The FDA also announced 1,300 warning letters and fines to online and traditional stores that have illegally sold Juul and other e-cigarettes to minors. Those five brands account for about 97% of the US e-cigarette market, the agency reported.
However, Gottlieb claims e-cigarette brands haven't done enough to stop kids from using the products.
As of 2017, more than two million high school-age Americans used e-cigarettes, a trend that represents a historic uptake of nicotine products, the FDA said. The FDA is now developing a survey to determine what percentage of youth vapers are using Juul products, Gottlieb said.
While e-cigarettes were first marketed to help adults quit smoking combustible cigarettes, they have now become a gateway to nicotine for teenagers. He said in June tobacco companies "better step up and step up soon" but he didn't divulge what consequences the industry could face - until now.
"We need to go further", said Michael Bloomberg, the billionaire philanthropist who has worked for years to reduce tobacco use. As long as some retailers are careless, some adults are willing to buy e-cigarettes on behalf of minors, and some teenagers manage to swipe them from parents or older siblings, there will be leakage from the adult market.
"The agency is asking each company to submit to FDA within 60 days plans describing how they will address the widespread youth access and use of their products", the FDA said in a release.
Shares of British American Tobacco were up almost 6 percent and shares of cigarette-maker Imperial Brands PLC were up more than 3 percent.
The owners of Vuse, MarkTen XL, Blu and Logic did not immediately respond to requests for comment. But the agency also thinks ENDS makers should consider "revising your current marketing practices to help prevent use by minors" and "removing flavored products from the market until those products can be reviewed by FDA as part of a [pre-market approval application]". It was "the largest coordinated enforcement effort in the FDA's history", according to the agency. Otherwise, the FDA could require the tobacco makers to stop selling the flavored products that appealed to children.
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. The premise of such threats is that the interests of adults who might want to switch from smoking to a far less hazardous form of nicotine consumption should be sacrificed for the sake of curtailing e-cigarette use by minors, which is already illegal.
"The FDA should immediately move to regulate flavored e-cigarettes, instead of waiting until 2022, as it is now planning to do", Bloomberg said in a statement. "And they [teens] have adopted it", Gould said.