FDA Conducts Surprise Inspection Of E-Cig Maker
- Oct 11, 2018 -

FDA investigators seized more than a thousand pages of documents from the San Francisco corporate headquarters of electronic cigarette maker JUUL Labs, agency officials confirmed Tuesday.

The surprise on-site inspection, and seizure of sales and marketing documents, late last week followed FDA Commissioner Scott Gottlieb's written request to JUUL Labs asking for documents to help agency officials understand and address the reasons for the reported skyrocketing increase in sales of the e-cigarette brand to teens.

The CDC reported Tuesday that sales of JUULs, which are shaped like USB flash drives, grew more than seven-fold from 2016 to 2017, and that the brand was the top selling e-cigarette in the U.S. starting in December 2017.

Prior to late 2017, British American Tobacco had the largest share of the e-cigarette market in the U.S., wrote Brian A. King, PhD, MPH, of the CDC in Atlanta, and colleagues in a research letter in JAMA.

Sales of JUUL e-cigarettes increased 641% from 2016 to 2017 and by December 2017, JUUL Labs' monthly e-cigarette sales surpassed those of British American Tobacco, the investigators wrote.

The CDC study did not address the reasons for the rapid growth in JUUL sales, but anecdotal reports suggest that the brand is wildly popular among teens, who are attracted to the unique shape and appealing flavors like creme brulee, mango, and cool cucumber.

In September, Gottlieb declared teen use of electronic cigarettes an "epidemic," as he announced what he termed "the largest coordinated tobacco compliance effort in FDA's history" to address the issue.

The FDA commissioner acknowledged that federal health officials were slow to recognize the growing popularity of JUUL and other e-cigarettes among teens. To address adolescent use, the FDA may shorten the time that most e-cigarettes now being sold can stay on the market without review. A previously announced FDA extension of the review deadline was widely criticized by anti-smoking groups. FDA is also considering banning some or all e-cigarette flavorings.

In his earlier remarks, Gottlieb criticized e-cigarette manufacturers for failing to address teen use of their products.

"I've been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends," he said at the time. "In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products. And the risks mounted."

In a statement addressing last week's on-site inspection of JUUL Labs corporate headquarters, FDA officials revealed that several contract manufacturer facilities had also been visited, with the goal of assessing compliance with all applicable FDA laws and regulatory requirements.

"The new and highly disturbing data we have on youth use demonstrates plainly that e-cigarettes are creating an epidemic of access to these products among kids," the statement read.

The study by King's group was funded by the CDC. King and co-authors disclosed no relevant relationships with industry.