The Food and Drug Administration conducted a surprise inspection of the headquarters of the e-cigarette maker Juul Labs last Friday, carting away more than 1,000 documents it said were related to the company’s sales and marketing practices.
The raid, announced Tuesday, was seen as an attempt to ratchet up pressure on the company, which controls 72 percent of the e-cigarette market in the United States and whose products have become popular in high schools. The FDA said it was particularly interested in whether Juul deliberately targeted minors as consumers.
“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 in a statement. “It is vital that we take action to understand and address the particular appeal of, and ease of access to, these products among kids.”
FDA officials described the surprise inspection as a follow-up to a request the agency made for Juul’s research and marketing data in April. Kevin Burns, Juul’s chief executive officer, said the company had already handed over more than 50,000 pages of internal documents to the FDA in response to that request.
“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,” he said.
In recent months, the FDA has increasingly expressed alarm over the prevalence of vaping among youths in high school and even middle school, which its commissioner, Dr. Scott Gottlieb, said had reached “epidemic proportions.”
The number of high-school students who used e-cigarettes in the past 30 days has risen roughly 75 percent since last year to about 3 million, according to preliminary unpublished data, confirmed by the FDA. Gottlieb has repeatedly noted that the candylike names and flavors of many vaping liquids seem intended to attract younger users.
A RAND Corp. study of 2,039 Californians from ages 16 to 20 beginning in 2015 through 2017, released Tuesday, offered new evidence for concern about teenage vaping. Published in the journal Nicotine and Tobacco Research, the report said that as teenagers who used e-cigarettes grew older, many began smoking traditional cigarettes, which are more dangerous, as well.
By the end of the study period, over half of e-cigarette users were also smoking cigarettes.
In another report released Tuesday and published in the journal JAMA, the Centers for Disease Control and Prevention highlighted the dominance of Juul in the e-cigarette market. The CDC noted that Juul Labs’ sales soared from 2.2 million devices in 2016 to 16.2 million devices last year. The CDC’s figures only included those from retail stores, not the internet, which is also a major source of sales.
Other recent studies have also pointed out that teenagers are increasingly using vaping devices for marijuana consumption.
Many adult consumers of e-cigarettes say the devices have helped them move away from smoking traditional cigarettes, or quit entirely. But a growing number of teenagers who have never smoked are also turning to e-cigarettes, believing that they are relatively harmless products.
But though e-cigarettes do not have the carcinogens that come from burning tobacco, they, especially Juul, can have strong concentrations of nicotine, which is highly addictive, and detrimental to the developing adolescent brain.
In September the FDA announced a flurry of fines and warning letters that it had sent to convenience stores for selling e-cigarettes to underage customers. (It is illegal to sell the devices to anyone under 18.) The agency said it would also go after online sales, pointing out that bulk purchases were possible red-light indicators that a buyer might then resell devices to minors.
The agency has given Juul and four other e-cigarette manufacturers a 60-day deadline to produce plans showing how they will limit access to teenagers. Recently, it started its own multimillion-dollar campaign of posters for high school bathrooms and public service announcements on popular websites to warn teens of the dangers of vaping nicotine.
