SAN FRANCISCO-- The U.S. Food and Drug Administration (FDA) conducted an unannounced on-site inspection of the headquarters of electronic-cigarette manufacturer Juul Labs at the end of September, focusing its inquiry on the company’s sales and marketing practices, the agency told CSP Daily News.
As part of the FDA's ongoing efforts to prevent youth use of tobacco products, particularly e-cigarettes, it conducted the inspection Sept. 28 and collected “over 1,000 pages of documents,” it said.
San Francisco-based Juul did not respond to CSP's request for comment by press time, but previously it has said it intends to cooperate with FDA inquiries.
The September inspection followed the agency’s call for information issued in April, the FDA said. Its goal was to “better understand the reportedly high rates of youth use and the youth appeal of Juul products, including documents related to marketing and product design.”
Earlier this year, the FDA conducted inspections of several of Juul’s contracted manufacturing facilities, officials said, pointing out that the purpose of those inspections was to determine 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 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.”
In addition to the Juul inspections, FDA announced a series of actions in September, including the results of a retailer enforcement blitz and requests to five major e-cigarette manufacturers for plans on how the manufacturers will address the widespread use of their products by minors.
Nielsen data showed volume for e-cigarettes across all retail channels increased 113.6% in the four-week period ending Sept. 8, according to Wells Fargo Securities, New York. Juul accounted for the bulk of that volume with 72.8% share, Nielsen said.