E-cigarette company Juul illegally marketed its nicotine pods as less harmful than cigarettes, federal health authorities said Monday.
In a warning letter to the company, the Food and Drug Administration (FDA) said Juul "ignored the law" and unless corrective actions are taken in the next 15 days, the agency could fine the company or even seize its products.
The warning letter comes after the agency said it reviewed testimony made by Juul executives during a House Oversight and Reform subcommittee hearing in July.
"The law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful," acting FDA Commissioner Norman "Ned" Sharpless said in a statement.
"JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” Sharpless said.
According to the letter, Juul's labeling and advertising activities deliberately misled customers by saying the products are less harmful than cigarettes and would represent a lower risk of a tobacco-related disease.
Companies need FDA approval to claim their products are less harmful than traditional cigarettes, and Juul did not have that.
FDA investigators found the company broke the law “by selling or distributing them as modified risk tobacco products without an FDA order in effect that permits such sale or distribution.”
Sharpless specifically cited examples from the July hearing as evidence. For example, a student said a Juul representative visited his school and made a presentation to students saying Juul “was much safer than cigarettes” and that the “FDA would approve it any day.”
The warning letter echoes concerns raised by Rep. Raja KrishnamoorthiSubramanian (Raja) Raja KrishnamoorthiFDA authorizes an e-cigarette for first time, citing benefit for smokers Congressional investigators find more cases of baby food with toxic heavy metals Overnight Health Care — Presented by Indivior — Walensky gives green light for boosters MORE (D-Ill.), who last week accused Juul of illegally marketing its product as a smoking cessation device.
The FDA also sent a separate letter, requesting more information about Juul’s marketing practices. Specifically, the FDA said it wants to learn more about the scientific evidence behind about Juul’s claims about “switching.”
“The agency is concerned these statements and representations may convey that switching to JUUL is a safer alternative to cigarettes, in that using JUUL products poses less risk or is less harmful than cigarettes,” the letter stated.
A Juul spokesman said the company is reviewing the letters and intends to fully cooperate.