WASHINGTON — The Food and Drug Administration on Wednesday warned that teenage use of electronic cigarettes has reached "an epidemic proportion," and it gave Juul Labs and four other manufacturers 60 days to prove they can keep their devices away from minors.
If they don't, the agency said, it may remove their flavored products from the market.
The order was part of a sweeping government action that targeted both makers and sellers of e-cigarettes. The agency said it was sending warning letters to 1,100 retailers — including 7-Eleven stores, Walgreens, Circle K convenience shops and Shell gas stations — and issued another 131 fines, ranging from $279 to $11,182, for selling e-cigarettes to minors.
Federal law prohibits selling e-cigarettes to anyone under 18. In a briefing with reporters, the FDA commissioner, Dr. Scott Gottlieb, said that more than 2 million middle and high school students were regular users of e-cigarettes last year.
The government's tactics underscore a dilemma in the public health community: In addressing one public health problem — cigarette smoking, which kills 480,000 people in the United States each year — e-cigarettes are creating another — hooking teenagers who have never smoked on nicotine.
E-cigarette users inhale far fewer toxic chemicals than do smokers of traditional cigarettes. But they can take in higher levels of nicotine, which is addictive.
"The developing adolescent brain is particularly vulnerable to addiction," the FDA said in its statement announcing the actions.
Gottlieb said the FDA would look closely at whether manufacturers were allowing bulk purchases of products through their own websites — a practice where the buyer could then sell to minors.
If such "straw sales" are happening, it should be readily apparent to the manufacturers, he said. "If the companies don't know, or if they don't want to know, we'll now be helping to identify it for them."
If necessary, he continued, the FDA would bring criminal or civil charges.
In an emailed statement, a Juul spokeswoman said: "Juul Labs will work proactively with FDA in response to its request. 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 other four products facing the 60-day deadline are RJR Vapor Co.'s Vuse, Imperial Grand's blu and devices made by Logic. They said they were working with the FDA as well.
RJR, Imperial and Altria are all major tobacco companies. As smoking rates have declined, the industry sees e-cigarettes as an important piece of its survival, a fact that makes some in public health mistrustful.
"They say they've changed from the days of Joe Camel," Gottlieb said. "But look at what's happening right now, on our watch and on their watch. They must demonstrate that they're truly committed to keeping these new products out of the hands of kids."
Gottlieb has said many times he believes that e-cigarettes and similar products known as electronic nicotine delivery systems may be effective options for adults who want to stop smoking but still crave nicotine. But he said teenage vaping has become so concerning that regulators may have to curb the availability of the devices to keep them out of the hands of youths.
"Inevitably what we are going to have to contemplate are actions that may narrow the off-ramp for adults who see e-cigarettes as a viable alternative to combustible tobacco in order to close the on ramp for kids," Gottlieb said. "It's an unfortunate trade-off."
Gottlieb's aggressive approach against private industry is unusual for an official in the business-friendly Trump administration which has sought to roll back numerous environmental and health regulations. But critics said that his decision last summer to extend a deadline for e-cigarette manufacturers to demonstrate that their products comply with public health concerns helped perpetuate the current problem.
"It's nice they want to do something but realistically, what are they going to accomplish this way when they could be so much more effective by following the regulatory plan that had been ready to put into place and that the commissioner postponed?" said Diana Zuckerman, president of the National Center for Health Research, a nonprofit health policy group.
She also pointed to the popularity of vaping among young adults. Researchers generally believe that the adolescent brain continues to develop through age 26. "It's a big epidemic among people ages 18 to 30, too, " she said.
The attorney general of Massachusetts, Maura Healey, who recently began an investigation into the marketing and sale of e-cigarettes to minors, praised the FDA's action.
"We've worked too hard over the past 50 years to reduce smoking rates among young people to let these companies profit off of getting them hooked on nicotine," Healey said. "This move by the FDA is a good first step to shut down companies targeting minors."