The FDA is alarmed that, according to the National Youth Tobacco Survey (NYTS), "more than 2 million middle and high school students were current users of e-cigarettes in 2017". It's simply not tolerable.
The organisation warned the country's five largest e-cigarette makers that their products - Juul, Blu, MarkTen, Vuse and Logic - could be banned unless the companies could prove within 60 days that they had effective plans to stop sales to children.
Despite the fact that they can not legally be sold to anyone under 18, e-cigarettes - hand-held vaporizers that create aerosols from liquids typically packed with nicotine and other chemicals, often including flavorings - are now the most popular tobacco product among high school students, recent federal data shows.
"This is potentially the most important step FDA has taken to curtail youth use of e-cigarettes", said the group's president, Matthew Myers.
In his remarks to FDA staffers, Gottlieb acknowledged that some adults might get hurt by a crackdown on flavored e-cigarettes.
"Let me be clear: Everything is on the table, including all our civil and criminal enforcement tools", Gottlieb said in a speech at FDA headquarters in Washington, D.C. The "epidemic" perceived by the FDA is mainly an epidemic of e-cigarette experimentation, and even that trend seems to have reversed, judging from the latest NYTS results.
And some of the retailers that received warning letters are still advertising and selling these products, he said.
Juul Labs said it would work with the FDA and is committed to preventing underage use of its product.
"I'll be clear. The FDA won't tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products", Gottlieb said. 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 statement also states that the agency issued 1,300 warning letters and fines to retailers who were caught illegally selling products to minors in "an undercover blitz of brick-and-mortar and online stores this summer".
He said the FDA move could "represent a fundamental turning point" if the agency requires "all of these products undergo premarket review now, not four years from now".
Though Juul is by far the most popular e-cigarette device, two other companies, Vuse and Blu, have also received warnings.
Since the surge in teen use of the products began, the FDA and Juul have battled over the products consistently.
The agency said it plans to unveil a new e-cigarette public education campaign targeted to youth next week, and will soon announce wider access to new nicotine replacement therapies to help more adult smokers quit cigarettes. A government-commissioned report in January found "substantial evidence" that young people who use e-cigarettes are more likely to try cigarettes.
Traders said proposed FDA action was less harsh than feared. That initiative emerged from the agency's broader plan to regulate nicotine and tobacco, unveiled in July 2017, under the Family Smoking Prevention and Tobacco Control Act.