FDA raids Juul headquarters, seizes thousands of documents

Carleton English
October 2, 2018
New York Times
US health officials are turning up the heat on a leading e-cigarette maker.
In an amped-up battle to keep teenagers from vaping, investigators for the Food & Drug Administration raided the San Francisco headquarters of Juul Labs.
The raid on Friday, first disclosed on Tuesday, was an “unannounced on-site inspection” that yielded “over a thousand pages of documents,” the FDA said in a statement.
The agency said it was looking for materials tied to Juul’s “sales and marketing practices.”
It was one of several times the FDA inspected Juul’s facilities since issuing a request for information in April.
“The purpose of these inspections was to determine compliance with all applicable FDA laws and regulatory requirements,” the FDA said.
FDA Commissioner Scott Gottlieb, a former board member of e-cigarette retailer Kure Corp., as recently as last year thought that e-cigs could be used to wean adult smokers off of cigarettes.
But teen e-cig use has reached “epidemic” proportions, the FDA said last month when it warned it may ban the sale of flavored vaping cartridges.
“We see an opportunity for e-cigs to help adult smokers quit cigarettes and reduce their health risks; but we’ve said all along it can’t come at the expense of hooking kids on these products.” Gottlieb said in a tweet on Tuesday.
E-cig use has eclipsed cigarette use among high schoolers, with 11.7 percent of high school students using e-cigs compared with 7.6 percent using regular cigarettes, according to data from the Centers for Disease Control and Prevention.
While the FDA is looking at several e-cig manufacturers and retailers, Juul — known for its sleek design and fruit- flavored pods — has captured the most attention.
Over the past year, Juul saw its sales grow more than seven-fold, and now comprises roughly a third of e-cig sales in the US, the CDC said.
And this generation of kids — among the first to fully grow up with the notion that cigarettes are bad — has taken a liking to the USB-port-like devices.
“Them not being like cigarettes is appealing [to kids],” Dr. Pamela Ling, fellowship director for the Center for Tobacco Control Research and Education, told The Post.
“This seems like tech [to younger smokers],” said Ling, who noted she speaks with e-cig users. “[They say] it doesn’t really count as smoking.”
But the addictive behavior mirrors that of combustible cigarettes.
“The difference we see with Juul is [teens] talk more about nicotine,” Ling said, noting that many mention “head rushes” and “cravings” for the product.
While all e-cigs contain nicotine, Juul has “among the highest nicotine” content of all brands sold in the US,” the CDC said.
For its part, Juul said Tuesday that it has provided the FDA with more than 50,000 pages of documents since April and categorized the FDA’s inspection last week as “meetings” that were “constructive and transparent.”
Juul’s CEO said the company is “committed to preventing underage use.”