FDA Cracks Down on Sales of E-Cigarettes to Minors

Recognizing what it called “the troubling reality” that electronic cigarettes have become “wildly popular with kids,” the Food and Drug Administration on Tuesday announced a major crackdown on the vaping industry, particularly on the trendy Juul devices, aimed at curbing sales to young people.

The agency said it had started an undercover sting operation this month targeting retailers of Juuls, including gas stations, convenience stores and online retailers like eBay. So far, the FDA has issued warning letters to 40 that it says violated the law preventing sales of vaping devices to anyone under 21.

The agency also demanded that Juul Labs turn over company documents about the marketing and research behind its products, including reports on focus groups and toxicology, to determine whether Juul is intentionally appealing to the youth market despite its statements to the contrary and despite knowing its addictive potential. It said it planned to issue similar letters to other manufacturers of popular vaping products as well.

“We don’t yet fully understand why these products are so popular among youth,” the agency’s commissioner, Dr. Scott Gottlieb, said in a statement. “But it’s imperative that we figure it out, and fast. These documents may help us get there.”

Schools across the country say they were blindsided by the number of students turning up with Juuls last fall. Nicknamed the iPhone of e-cigarettes, Juuls resemble thumb drives, produce little plume, and smell like fruit or other flavorings, making them so concealable that students can vape in class. Students who would never think to smoke a cigarette post videos of themselves doing tricks with vaping devices on social media. Schools, fearing students are becoming addicted to nicotine, are suspending students as young as middle school for vaping.

In an emailed statement, Juul Labs said it agreed with the FDA “that illegal sales of our product to minors is unacceptable.”

“We already have in place programs to identify and act upon these violations at retail and online marketplaces, and we will have more aggressive plans to announce in the coming days,” the company’s statement said. “We are working with the FDA, lawmakers, parents and community leaders to combat underage use, and we will continue working with all interested parties to keep our product away from youth.”

The vaping industry has long challenged the argument that the devices are addictive and that flavorings appeal to youth, saying the evidence does not support this.

But on Tuesday, the FDA came down firmly about the risks. “The nicotine in these products can rewire an adolescent’s brain, leading to years of addiction,” Gottlieb said in his statement. He acknowledged that e-cigarettes “may offer a potentially lower risk alternative for individual adult smokers,” he added. “But the viability of these products is severely undermined if those products entice youth to start using tobacco and nicotine.”

Gottlieb said Tuesday’s announcement was the first of several steps the agency would be taking as part of a new Youth Tobacco Prevention Plan to get manufacturers to stop marketing e-cigarettes to young people. It has already convinced eBay to stop listing the products. It also asked Juul to turn over documents related to promotional games and contests, as well as anything related to product design and the appeal or addictive potential for youth.

But while the moves pleased some public health advocates and school administrators concerned about the popularity of “Juuling” among adolescents, other groups say they do not make up for the tremendous break Gottlieb cut the e-cigarette industry in July, when he allowed manufacturers a five-year extension on a rule that would have required them to prove that their products are a safe alternative to traditional cigarettes.

The vaping industry had lobbied hard against the rule, arguing that the cost of complying with such regulations would have deterred manufacturers from introducing new products that help adults quit smoking. Schools and public health advocates contend that the vaping industry is the latest incarnation of Big Tobacco, developing and promoting its products to create new markets for a younger generation. Juul comes in kid-friendly flavors like mango and creme brulee. The labels on other e-cigarette flavorings resemble popular candy brands like Jolly Rancher and Blow Pops.

The e-cigarette industry’s political clout has grown as the tobacco giants have taken over the business, which was once limited to small shops and manufacturers. Altria, British American Tobacco, Imperial Tobacco, Philip Morris International and Reynolds American all produce e-cigarettes now. In 2017, according to The Center for Responsive Politics, which tracks federal disclosure reports, the tobacco industry spent nearly $22 million on lobbying.

Juul, which was started by Pax Labs in 2015 and spun off into an independent company last year, is one of the biggest players, increasing its revenue by nearly 700 percent in 2017 to $224.6 million, according to a November report from Nielsen/Wells Fargo. The total e-cigarette market grew by 40 percent last year, to $1.16 billion.

Juul Labs told CNBC in October that while it was producing 20 million devices and flavored pods, it could not keep up with demand. Late last year, it raised more than $110 million in private funding, and hired a new chief executive officer from Chobani, manufacturer of the popular Greek yogurt.

According to Monitoring the Future, an annual survey done for the National Institute on Drug Abuse, part of the National Institutes of Health, in 2017, 19 percent of 12th-graders, 16 percent of 10th-graders and 8 percent of 8th-graders reported vaping nicotine in the past year.

Juul has come under increasing pressure over the last several weeks as parents and schools have become alarmed over how prevalent the devices are.

A coalition of medical and public health advocacy groups led by the Campaign for Tobacco Free Kids sued to reverse the FDA’s July extension of the regulations for e-cigarette companies. A group of U.S. senators led by Dick Durbin, D-Ill., sent a letter to Juul last week asking questions about marketing and ingredients for the devices and asking the company to do more to prevent minors from buying the devices.

On Tuesday, the health advocacy groups and lawmakers commended the FDA’s moves, but said the agency must go further and require e-cigarette companies to eliminate flavorings that clearly appeal to youth. They also pushed the FDA again to reverse its July decision.

According to the Juul website, the devices create an aerosol rather than using a flame to activate the ingredients. The company says the product produces a level of nicotine similar to a traditional cigarette in order to satisfy cigarette smokers who switch to vaping.

Medical researchers say this makes the Juul more addictive for youth.

“This is the definition of a double-edged sword,” said Michael Siegel of Boston University, who studies tobacco use.

Because Juul delivers nicotine in a more effective manner, it is appealing for adult smokers who are trying to give up tobacco cigarettes, he said. “The first time they use it, they feel the nicotine, they’re more likely to stick with it.” But for teenagers, “it’s a bad thing because it really does create the addiction potential that you don’t have with normal electronic cigarettes.” “What we used to see is kids would vape together in social settings, it was showing off who could blow the biggest rings,” he said. “Now we’re starting to see kids who literally are showing signs of addiction: They’re using it alone, we’re seeing kids who have to sneak off to the bathroom during the day.”

School health officials say students do not realize how much they are smoking because they “microdose” all day. And many do not realize the chemicals in the devices.

“They think of it as being just not that big a deal,” said Timothy Hayes, assistant superintendent for student services at New Trier, a large public high school in the Chicago suburbs. “It’s not smoke, I’m not inhaling, it’s just water vapor, that’s their thinking.”

The FDA crackdown, he said, could help make the risks clearer. “It makes public, and makes Juul be public, about the health consequences.”