The New York Times Company
Juul Labs, the dominant e-cigarette company, illegally marketed its vaping products as a safe alternative to traditional cigarettes, the Food and Drug Administration said Monday, casting a deepening shadow over the safety of e-cigarette devices.
The agency issued a warning letter to Juul, saying that the company violated federal regulations because it had not received federal approval to promote and sell its vaping products as a healthier option.
The FDA’s action dealt a setback to the company’s efforts to rebrand itself in the wake of public outrage over a surge in teenage vaping.
And it served as a reminder that the health effects of e-cigarettes are not established at a time when more than 400 people have been sickened by vaping-related illnesses. Five deaths have been linked to vaping and hundreds of people have been hospitalized. Public health investigators have yet to determine a specific cause, but they have cited the use of cannabis and nicotine vaping products as possibilities. No one product or company has been implicated.
The investigation into Juul’s practices preceded this summer’s spate of lung illnesses, and was prompted by concerns that the company’s marketing and sales practices targeted youths. It included a review of congressional testimony from Juul executives, consumers — students and parents — and anti-smoking activists.
“Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, 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,” said Dr. Ned Sharpless, the acting FDA commissioner. “Juul has ignored the law and, very concerningly, has made some of these statements in school to our nation’s youth.”
The agency Monday pointed to specific instances that it said violated restrictions on those health claims. It referred to a statement by Kevin Burns, the company’s chief executive, on the Juul website in which he said that the company’s vaping system was designed to “heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and harm associated with it.”
Juul asserted that it would fully cooperate with the investigation and has continued to argue that its target audience has always been adult smokers.