Juul’s office raided by FDA, which seizes documents

A student of Bishop O'Dowd High School smokes from a Juul e-cigarette at Mountain View Cemetery in Oakland, Calif. Wednesday, May 16, 2018. A student of Bishop O'Dowd High School smokes from a Juul e-cigarette at Mountain View Cemetery in Oakland, Calif. Wednesday, May 16, 2018. Photo: Jessica Christian, The Chronicle Buy photo Photo: Jessica Christian, The Chronicle Image 1 of / 4 Caption Close Juul’s office raided by FDA, which seizes documents 1 / 4 Back to Gallery

The Food and Drug Administration said Tuesday that it seized more than 1,000 pages of documents from Juul Labs during an unannounced site inspection of the e-cigarette manufacturer’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 American youths. It directed the industry’s giants to draw up detailed plans for halting sales to minors and threatening 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 CEO Kevin Burns said Tuesday in a statement that last week’s interactions with the FDA gave his company 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.” He said the company 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.”

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The FDA said it is “committed to taking all necessary actions, such as inspections and advancing new policies, to prevent a new generation of kids from becoming addicted to tobacco products.”

In April, the FDA asked Juul for documents that would help it “better understand the reportedly high rates of youth use and the youth appeal of Juul products, including documents related to marketing and product design,” according to a statement from the agency.

The agency had also previously 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 estimate 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 is 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.

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.

Samantha Masunaga is a Los Angeles Times writer.