Originally posted by The New York Times by Sheila Kaplan and Jan Hoffman on September 12, 2018.
Warning that teenage use of electronic cigarettes has reached “an epidemic proportion,” the Food and Drug Administration on Wednesday gave Juul Labs and four other makers of popular vaping devices 60 days to prove they can keep them away from minors. If they fail, the agency said, it may take the flavored products off the market.
The order was part of a sweeping 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, for selling e-cigarettes to minors.
In addition, the F.D.A. commissioner, Dr. Scott Gottlieb said in a briefing that the agency would look closely at the manufacturers’ own internet storefronts. He flagged what he called “straw purchases” — bulk orders of the devices, which buyers in turn used to sell to minors.
Such practices, he said, should be readily apparent to product manufacturers.
“If the companies don’t know, or if they don’t want to know,” he said, that such purchases are underway, “we’ll now be helping to identify it for them.”
He said that if necessary, the F.D.A. would bring criminal or civil charges.
The government’s aggressive 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.
“JUUL Labs will work proactively with F.D.A. in response to its request,” a Juul spokeswoman said in an emailed statement. “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, Altria Group’s MarkTen, Imperial Grand’s blu and devices made by Logic. Those companies were not immediately available for comment.
Dr. Gottlieb, has said many times that 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 in announcing the agency’s moves, he said 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,” Dr. Gottlieb said. “It’s an unfortunate trade-off.”
According to the agency, more than two million middle and high school students were regular users of e-cigarettes last year. Dr. Gottlieb made it clear that he did not think the companies have done enough to stop them.
“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,” Dr. Gottlieb said.
E-cigarette users inhale far fewer toxic chemicals than do smokers of traditional cigarettes. But they can take in higher levels of nicotine than in cigarettes. It is nicotine which is addictive and poses a serious health threat to teenagers.
“The developing adolescent brain is particularly vulnerable to addiction,” the F.D.A. said in its statement announcing the actions.
The wildly popular Juul, which offers especially potent nicotine hits, is the agency’s particular target. The company launched the sleek device, which looks like a flash drive, in 2015. It comes with “pods” in eight flavors, among them Mango, Menthol, Creme and Cucumber. In a short time it has become the dominant seller of e-cigarettes and a fad among students. According to Nielsen data, Juul controls 72 percent of the market, and is valued by investors at $16 billion.
In April, the F.D.A. announced it was investigating Juul’s marketing practices to determine if the company deliberately targeted youths. The agency requested reams of documents from the company, including focus group reports and toxicology studies. Juul has submitted thousands of pages of records to the agency, but neither the F.D.A. nor Juul have made them public. Dr. Gottlieb said the agency’s tobacco division is still poring through them.
While the actions against the industry are alarming to the e-cigarette companies, they are also problematic for the F.D.A.
In July 2017, as part of a broad plan to reduce tobacco deaths in the United States, the F.D.A. extended the deadline for e-cigarette makers to comply with new tough federal guidelines, which, among other things, require companies to prove the e-cigarettes are beneficial to public health. In granting the five-year extension till 2022, Dr. Gottlieb said he would also force manufacturers to cut nicotine levels in traditional cigarettes, to render them nonaddictive. For that to work, he said, smokers needed more and better cigarette substitutes.
But in an interview, Dr. Gottlieb said the immense popularity of vaping among teens was not something he foresaw last summer, and the agency must rethink its policy — perhaps moving the deadline closer and requiring companies to gain F.D.A. approval to stay on the shelves.
The attorney general of Massachusetts, Maura Healey, who recently began an investigation into the marketing and sale of e-cigarettes to minors, praised the F.D.A. for its new tactic.
“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,” Ms. Healey said. “This move by the F.D.A. is a good first step to shut down companies targeting minors.”
Juul spokeswoman Victoria Davis said recently that the company had already stepped up its own patrol of retailers who advertise to youths or who don’t enforce age requirements, as well as social media posts. But it’s not always easy.
From Jan. 1 through July 28, Ms. Davis said, Juul asked Instagram to remove over 5,500 posts, and the social media company complied on 4,562. Facebook Marketplace was less agreeable. The company agreed to remove 45 of 144 posts. Amazon took down 13 of 33.
Dr. Gottlieb said he was not impressed by the measures Juul and the other companies have taken.
“It didn’t have the intended impact or I wouldn’t be viewing the statistics I’m now seeing,” he said.
WHAT SHOULD I DO?
If you have used, or know someone who has used a Juul, we are here to help. The Hannon Law Firm is actively investigating this matter and would welcome the opportunity to talk to you about your concerns and experience. Contact us by calling 303-861-8800, or by filling out the contact form below.