Federal regulators just put Juul on notice.
The $38 billion e-cig company, partially owned by tobacco giant Altria, received a warning letter on Monday from the US Food and Drug Administration saying that it wrongly portrayed its devices as safer than cigarettes and marketed them intentionally to youth, including at high schools.
E-cigarettes like the Juul are sometimes called "ENDS," for electronic nicotine delivery systems.
"Referring to your ENDS products as '99% safer' than cigarettes, 'much safer' than cigarettes, 'totally safe,' and 'a safer alternative than smoking cigarettes' is particularly concerning because these statements were made directly to children in school," the FDA letter reads.
"Our concern is amplified by the epidemic rate of increase in youth use of ENDS products, including JUUL's products," the letter said.
Juul said in an e-mailed statement that it's "reviewing the letters and will fully cooperate."
A teen vaping epidemic
The FDA warning is another setback for Juul amid months of bad news for the e-cig maker, and for vaping in general. Juul has embarked on a media tour over the last several months, as its sleek devices face increasing scrutiny over their role in sparking a teen vaping epidemic. Use of Juuls has also potentially been tied to seizures, Bloomberg News reported.
Meanwhile, regulators are also investigating five deaths and more than 450 cases of serious lung disease tied to vaping. For now, that investigation is mainly focused on people who said they vaped marijuana, but some reports included mention of nicotine as well.
Read more: Here are all the health risks of vaping
Juul has conducted a series of media appearances over the last several months. In July, Juul CEO Kevin Burns apologized to parents of kids addicted to Juul. Last month, Burns warned people against using the Juul. In the same appearance, Burns also said his company was helping smokers quit.
Read more: Here's the real reason that Juul's CEO is warning people against using his e-cigs
Juul now has 15 working days to respond to the FDA and correct the problems identified by the agency.
Juul has walked a fine line between portraying its products as a trendy gadget and a healthcare tool. Products like Juul can't be explicitly marketed as tools for quitting smoking, according to federal law. But that doesn't mean companies who make them can't suggestively advertise them as such.
In March, Juul put out a study suggesting that some adult smokers may be using Juuls to wean themselves off regular cigarettes. The study, published four years after Juul's products had been on the market, was paid for by Juul.
During one of his recent media appearnces Burns said Juul was "absolutely contributing to the decline of the smoking rate." Smoking rates in the US have been steadily declining since the 1960s, reaching the lowest level ever recorded in 2017, according to the CDC.
