The Food and Drug Administration (FDA) is accusing e-cigarette manufacturer Juul of illegally marketing its products as less harmful than combustible tobacco.
According to The New York Times, the F.D.A. issued its warning letter Monday. In it, the FDA noted that Juul never received regulatory approval to promote vapes as a healthy alternative to traditional cigarettes.
The warning comes amidst much turmoil in the e-cigarette sector. Juul, along with several of its competitors, has been sued numerous times for allegedly marketing its products to under-age teens. Several lawsuits are still pending.
And, as the Times notes, recent studies have cast doubt on Juul’s claims of being a safe out for smokers. An estimated 400 people have fallen ill from vaping—and at least five individuals have died from it.
Acting F.D.A. Commissioner D. Ned Sharpless said that no matter the risk or lack thereof, Juul has a responsibility to the law.
“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,” Sharpless said. “Juul has ignored the law and, very concerningly, has made some of these statements in school to our nation’s youth.”
In its Monday letter, the F.D.A. highlighted some of Juul’s alleged transgressions. In one statement—uploaded to the company’s website by its CEO, Kevin Burns—Juul said its vapes are designed “to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and harm associated with it.”
Juul also may have given a presentation at a school, telling students that vaping is “much safer than cigarettes.”
The Times says that high levels of nicotine in Juul products are ‘of particular concern for their effects on the still-developing brains of a generation of teenagers.’ E-cigarettes might act as a gateway drug—presumably the author means to actual tobacco—reversing a historic downturn in nicotine abuse rates among youth and young adults.
To fix what’s increasingly being viewed as an epidemic, the F.D.A.’s warning was accompanied by a directive: that Juul should correct the issues outlined within 15 days.
The American Medical Association also released a statement Monday, urging the F.D.A. to step up its regulation of Juul.
“We must not stand by while e-cigarettes continue to go unregulated,” said AMA’s president, Dr. Patrice Harris. “We urge the FDA to speed up regulation of e-cigarettes and remove all unregulated products from the market.”