"I think it became clear to FDA that if they didn't get their arms around this issue the use of these products by kids across the nation would undo decades of progress", said Matthew Myers of the Campaign for Tobacco-Free Kids.
And if the trends in use that we're seeing right now continue, we're going to have to take even more dramatic actions.
It marks a shift in the agency's tone on e-cigarettes.
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 says it has issued "more than 1,300 warning letters and fines to retailers" as a result of "a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors".
The FDA has given five companies - Vuse, Blu, JuuL, MarkTen XL, and Logic- 60 days to come up with a plan to keep teenagers from using its devices and sent warning letters to 1,300 companies that it caught selling the device to minors.
"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", he added.
FDA Commissioner Scott Gottlieb announced the plan Wednesday, saying the agency is giving the manufacturers of Juul, Vuse, MarkTen, Blu, and Logic-which make up more than 97% of the United States e-cigarette market-60 days to submit their plans, USA Today reports.
Gottlieb said the FDA recognized the impact this might have on adults trying to stop smoking, but said that emerging research on how flavored products encourage excessive use by young people shows action must be taken.
"We're especially focused on the flavored e-cigarettes", said Gottlieb. 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.
"If a kid comes in, even over 18, and I ask him, 'Have you ever smoked a cigarette?' He says, 'No.' 'Did you ever Vape before?' He goes, 'No.' Then I'll tell him, 'Why do you want to start?'" Lee said.
Manufacturers offer and market e-cigarette flavors that appeal to minors, including candy, bubble gum, and fruit flavors.
"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. Altria Group Inc. and British American Tobacco Plc had the biggest one-day percentage gain in about a decade.
"By working together, we believe we can help adult smokers while preventing access to minors", the company said in a statement. Regulators said it was the largest coordinated crackdown in the agency's history.
As of September 1, the FDA said it has conducted 978,290 retail inspections, issued 77,180 warning letters to retailers for violating the law, and initiated 18,560 civil money penalty cases in its checks of retail establishments selling tobacco products.
"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.
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". "Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes. And they [teens] have adopted it", Gould said.