FDA conducts surprise inspection of Juul Labs in San Francisco
SAN FRANCISCO - The Food and Drug Administration seized more than 1,000 pages of documents from e-cigarette maker Juul Lab's San Francisco headquarters as part of the federal agency's efforts to see how the company is marking to young people.
CNBC first reported the news.
“As part of FDA’s ongoing efforts to prevent youth use of tobacco products, particularly e-cigarettes, last week the agency conducted an unannounced on-site inspection of e-cigarette manufacturer Juul Lab’s corporate headquarters," the FDA told KTVU in an emailed statement on Tuesday.
The inspection, completed on Friday, sought further documentation related to Juul’s sales and marketing practices, among other things, "and resulted in the collection of over a thousand pages of documents," the FDA said.
Kevin Burns, CEO of Juul Labs, responded to the inspection by vowing that his company is "committed to preventing underage use."
Burns said in a statement sent Tuesday to KTVU that Juul wants to "engage with FDA, lawmakers, public health advocates and others to keep JUUL out of the hands of young people."
He described the surprise inspection as "meetings," and said they gave Juul 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 Juul is being transparent and said that since April, the company has released more 50,000 pages of documents to the 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," Burns wrote.
Earlier this year, FDA also conducted inspections of several of Juul's contract manufacturing facilities. "The purpose of these inspections was to determine compliance with all applicable FDA laws and regulatory requirements," the agency said.
It is unclear at this point what all the documents will reveal. But it's clear the FDA is concerned about the rise of Juul-ing and vaping among youth. The company was founded in 2015, and morphed into its current Juul Labs last year. Bloomberg reported in August that Juul Labs was valued at $15 billion.
The product is shaped like a USB drive and each starter pack is flavored with mango, fruit and cucumber. The concentration of nicotine in each Juul pod is about twice that of many other e-juice nicotine concentrations, listed at 5 percent nicotine by weight versus the more common 2.4 percent or less in other e-juices, according to the American Academy of Family Physicians.
And it's this combination of tasty flavoring and high nicotine content that has the FDA worried.
"The new and highly disturbing data we have on youth use demonstrates plainly that e-cigarettes are creating an epidemic of regular nicotine use among teens," the FDA said. "It is vital that we take action to understand and address the particular appeal of, and ease of access to, these products among kids."