The Food and Drug Administration seized more than 1,000 pages of documents in a surprise inspection of e-cigarette maker Juul Labs, the latest indication of an intensifying crackdown on underage vaping.
The agency, in a statement Tuesday, said that last week’s inspection of Juul’s corporate headquarters in San Francisco was part of an effort to seek “further documentation related to Juul’s sales and marketing practices.”
The Juul product, which is sleek and shaped like a USB drive, has surged in popularity, including among high school students. Critics say some of the e-liquid flavors, including mango and creme, make the product especially appealing to minors. But vaping defenders say such flavors are critical to helping adult smokers switch from more dangerous combustible cigarettes to safer e-cigarettes.
The attention on Juul ratcheted up when the Centers for Disease Control and Prevention issued a new report Tuesday showing the company’s sales grew more than sevenfold from 2016 to 2017. The analysis of retail sales data – published in JAMA, the Journal of the American Medical Association – found that Juul’s sales increased from 2.2 million devices sold in 2016 to 16.2 million in 2017.
Also Tuesday, U.S. Sens. Dick Durbin, D-Ill., and Lisa Murkowski, R-Alaska, wrote to the FDA asking it to immediately ban e-cigarette flavorings that appeal to children and to restrict online sales of nicotine products.
“While it remains unclear whether e-cigarettes can actually help adults quit smoking cigarettes, it is abundantly clear that tobacco companies are developing and marketing e-cigarette flavors that appeal to, and addict, children,” the senators said in the letter.
Earlier this year, the senators introduced a bill to sharply restrict e-cigarette flavors unless companies produced evidence that the flavors helped adults quit smoking conventional cigarettes and did not increase youth taking up nicotine or tobacco products.
In a statement Tuesday, Juul Lab’s chief executive Kevin Burns said that the company is “committed to preventing underage use, and we want to engage with FDA, lawmakers, public health advocates and others to keep Juul out of the hands of young people.”
He added that last week’s meetings with the FDA “gave us 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. It was a constructive and transparent dialogue.”
The FDA inspection followed the agency’s request to the company this year for information on the high rates of youth use of Juul products, including “documents related to marketing and product design,” the agency noted in its statement Tuesday.
Last month, FDA commissioner Scott Gottlieb said that teenage vaping had become an “epidemic.” He launched a massive enforcement action against retailers for allegedly selling e-cigarettes to minors and warned manufacturers of a potential ban on flavored e-cigarette liquids.
He also demanded that five leading e-cigarette manufacturers, including Juul, submit plans within 60 days detailing ways to sharply curb sales to underage consumers. Unless the plans promise to “substantially reverse” the youth-use trend, Gottlieb said, the agency would consider steps that could lead to temporary or permanent removal of flavored products from the market. In recent days, he has also said the FDA is considering banning online sales of e-cigarettes.
On Tuesday, the FDA said in its statement that “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. It is vital that we take action to understand and address the particular appeal of, and ease of access to, these products among kids.”
People familiar with the situation say the data show a 75 percent increase in youth use of e-cigarettes this year, compared to last year. The information reportedly comes from the National Youth Tobacco Survey, which is conducted by the FDA and the CDC.
Earlier this year, the FDA also conducted inspections of several of Juul’s contract manufacturing facilities to see if the company was complying with regulatory requirements.
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