"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", Juul spokesperson Victoria Davis said in a statement provided to TIME.
"Well, I'm here to tell them that this prior approach is over". Regulators said it was the largest coordinated crackdown in the agency's history.
FDA Commissioner Scott Gottlieb has said that e-cigarettes, while still harmful, may be effective for adults who want to give up cigarette smoking, which kills nearly half a million Americans each year.
The FDA set a 60-day deadline for five major tobacco manufacturers to provide a plan for mitigating youth sales, or the agency will pull them out of the market.
It will also "re-visit" the policy it announced previous year, which gave e-cigarette companies more time to apply for regulatory approval. The products being targeted are: Juul, MarkTen by the Altria Group, the maker of Malboro cigarettes in the US, Blu by Fontem Ventures, Vuse, by British American Tobacco, the company that makes Camel cigarettes, and a device called Logic.
Gottlieb cited preliminary data that has not yet been published, but which he said shows "youth use of e-cigs is rising very sharply".
The FDA sent 1,300 warning letters and fines to retailers in "a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors". 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.
Under regulations developed by the Obama administration, manufacturers were supposed to submit most products for review by August 2018.
"I have grown increasingly concerned around what we see as rising youth use in these products, and I'm disappointed in the actions the companies have taken to try to address this", Gottlieb said at a press briefing. Those five brands account for about 97% of the US e-cigarette market, the agency reported.
During the 60-day waiting period, the FDA plans to investigate the five companies' marketing and sales practices, with possible "boots on the ground inspections", Gottlieb said.
The FDA also plans to revisit its policy that extended the dates for manufacturers of certain flavored e-cigarettes to apply for premarket authorization.
The agency said it continues to check retail stores that sell tobacco, to ensure they are in compliance with federal laws. The company has more than two-thirds of the USA e-cigarette market, according to Nielsen data. If the FDA sees continued underage use as an argument for banning e-cigarettes, the industry is doomed, even though it offers what the agency recognizes as "an alternative for adult smokers who still seek access to satisfying levels of nicotine, but without all of the harmful effects that come from combustion".
"In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate and the existential threat to these products, and as they did, these risks have mounted", Gottlieb said.
The other companies also said they would work with the FDA on youth prevention efforts.