The Food and Drug Administration announced Tuesday that it seized more than 1,000 pages of documents from Juul Labs Inc. during an unannounced inspection of the dominant e-cigarette brand’s San Francisco headquarters.
The FDA said the inspection, which it completed Friday, sought documents related to Juul’s sales and marketing practices, among other things.
The inspection came weeks after the agency announced a comprehensive crackdown on e-cigarette manufacturers, citing an “epidemic of nicotine addiction” among U.S. youths. It directed the industry’s giants to draw up detailed plans for halting sales to minors and threatened to pull a wide range of products, including flavorings that appeal to underage buyers.
The FDA would not answer questions about whether Juul willingly handed over the documents collected from its headquarters last week or whether the company was being accused of wrongdoing.
Juul Chief Executive Kevin Burns said Tuesday in a statement that last week’s interactions with the FDA enabled his company to provide information about a variety of topics, including its marketing strategy and online age-verification protocols. He said Juul has released more than 50,000 pages of documents to the FDA since April that “support our public statements.”
“It was a constructive and transparent dialogue,” he said in the statement. “We are committed to preventing underage use.”
The FDA said that in April, it asked Juul for documents, including those related to marketing and product design, that would help it understand the appeal of Juul products and those products’ reportedly high rates of use among young people.
The agency had also conducted inspections of several of Juul’s contract manufacturing facilities to see if they complied with regulatory requirements.
Burns said in his statement that Juul will release a plan to “address youth access” in 60 days, as outlined by the FDA.
E-cigarettes started to gain popularity in the last five years. The battery-powered, handheld devices heat nicotine-infused liquid into an inhalable mist, which users puff as if smoking a cigarette. Most e-cigarettes use replaceable, liquid-filled cartridges that come in a variety of flavors. Juul flavors include mango, cucumber and Virginia tobacco.
Flavors are of particular concern to the FDA. Scott Gottlieb, the agency’s commissioner, said last month that “certain flavors are one of the principal drivers of the youth appeal of these products.”
Analysts at Wells Fargo estimated that Americans bought more than $2.3 billion worth of e-cigarettes from August 2017 to August 2018, and they expect annual sales to reach nearly $4 billion this year.
Juul hit the market in 2015 and has become the clear leader among e-cigarette brands, with $454 million in sales over the 12 months that ended in February, according to the Wells Fargo report, which cited market data from the research firm Nielsen.
In July, the company had a funding round that valued it at about $15 billion, according to multiple news outlets.
Juul sold 16.2 million devices last year, more than seven times as many as it sold the previous year, according to an analysis of retail sales data released Tuesday by the Centers for Disease Control and Prevention.
Add in other vaping products — including vapor cartridges and related items sold at specialty shops — and analysts say the entire market could be worth $6.6 billion this year.
Times staff writer James Rufus Koren contributed to this report.
2:55 p.m.: This article was updated with Juul’s reported valuation in July.
12:50 p.m.: This article was updated with information from a CDC analysis of retail sales data of e-cigarettes.
9:50 a.m.: This article was updated with comments from Juul CEO Kevin Burns; more information about the FDA crackdown on e-cigarettes and interactions with Juul; and details about the rise of vaping in the United States.
This article was originally published at 9:15 a.m.