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The FDA said its unannounced visit of Juul collected documents on the e-cigarette-maker’s sales and marketing practices.
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Gabby Jones/Bloomberg News
The Food and Drug Administration conducted a surprise inspection of Juul Labs Inc.’s San Francisco headquarters last week as U.S. health officials combat what they call the harmful and surging use of e-cigarettes by youngsters.
FDA inspectors collected more than a thousand pages of documents at the e-cigarette startup’s offices, focusing on sales and marketing practices, the agency said Tuesday.
Juul Chief Executive Kevin Burns said the company had “constructive and transparent” meetings with inspectors. He added that Juul has now released more than 50,000 pages of documents to the FDA, following the agency’s initial request in April for information that could help explain why its devices and flavored liquids appeal to youths.
“We want to be part of the solution in preventing underage use,” Mr. Burns said.
The use of Juul and similar USB-shaped e-cigarettes is “especially dangerous among youth because these products contain extremely high levels of nicotine, which can harm the developing adolescent brain,” said Corinne Graffunder, director of CDC’s Office on Smoking and Health.
Last week’s headquarters visit followed FDA inspections earlier this year of Juul’s facilities. An agency spokeswoman declined to comment Tuesday on the inspectors’ findings.
Juul last year sold 16.2 million of its devices, according to data released Tuesday by the Centers for Disease Control and Prevention. That was up from the 2.2 million Juul devices sold in 2016, the CDC said.
Sales of the devices and accompanying pods of nicotine-laced liquids have continued to surge this year. Juul now represents 73% of the $2.5 billion U.S. e-cigarette market, according to a Wells Fargo analysis of Nielsen data. That doesn’t include internet sales.
The number of high-school students who used e-cigarettes in the past 30 days has risen roughly 75% since last year to about three million, or about 20% of high-school students, according to unpublished preliminary federal data.
FDA Commissioner Scott Gottlieb said in September that teen use of e-cigarettes “has reached an epidemic proportion.” He announced new measures to curb teen vaping and said he was considering banning flavored products.
Write to Jennifer Maloney at [email protected]
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