Why Juul Is At the Center of the FDA’s E-Cigarette Investigation

The Food and Drug Administration (FDA) continued its blitz on e-cigarette use by surprising top manufacturer Juul Labs with an inspection of its San Francisco headquarters last week, resulting in the seizure of “thousands of pages of documents,” the agency said.

The investigation, which was aimed at learning more about Juul’s sales and marketing practices, was the latest in a string of moves by the FDA to further understand and regulate e-cigarette use — a campaign that has been seemingly centered on Juul.

In April, the agency requested marketing documents from Juul and several other manufacturers, in an effort to better understand the youth appeal of these products. Then, in September, it gave Juul and four other companies 60 days to construct plans for curtailing the “epidemic” of youth use; failure to do so, the agency said, could result in some or all flavored products — which seem to be especially appealing to kids — being pulled from store shelves.

While all e-cigarettes fall under the FDA’s purview, Juul has attracted special interest from the agency. That’s, in large part, for a simple reason: Juul is staggeringly popular, both with adult and youth users.

The company’s sales skyrocketed by 641% between 2016 and 2017, according to Centers for Disease Control and Prevention (CDC) data published in JAMA Tuesday. Juul sold 16.2 million vapes in 2017, accounting for one in three e-cigarettes purchased by the end of that year, according to the CDC data.

But of special interest to the FDA is Juul’s appeal to kids and teenagers. The sleek vapes, which are often said to resemble flash drives and can be paired with flavor pods like mint, fruit and creme, have popped up in schools across the country, sparking concern among parents, educators and regulators alike. Research has shown that kids who use e-cigarettes, which usually contain addictive nicotine, may be more likely to pick up cigarettes and other tobacco products later on.

Youth use of e-cigarettes increased by 75% between 2017 and 2018, according to early reports of not-yet-published federal data, which would mean about 20% of U.S. high schoolers, or some 3 million teenagers, vape. The FDA does not have data about which brands are used by teenagers, but the agency plans to add a question specifically about Juuling to the 2019 version of the National Youth Tobacco Survey.

Juul CEO Kevin Burns emphasized in a statement provided to TIME after the recent FDA inspection that Juul’s products are made only for adult smokers, and that the company does not condone youth vaping. E-cigarettes are not legally available to anyone under 18; they are typically meant to give adult smokers a healthier alternative to cigarettes.

“We are committed to preventing underage use, and we want to engage with FDA, lawmakers, public health advocates and others to keep JUUL out of the hands of young people,” Burns said in the statement. “The meetings last week with FDA gave us the opportunity to provide information about our business from our marketing practices to our industry-leading online age-verification protocols to our youth prevention efforts. It was a constructive and transparent dialogue. We’ve now released over 50,000 pages of documents to the FDA since April that support our public statements. We look forward to presenting our plan to address youth access in the 60-day time frame as outlined by FDA. We want to be part of the solution in preventing underage use, and we believe it will take industry and regulators working together to restrict youth access.”