The US Food and Drug Administration on Monday warned leading e-cigarette maker Juul Labs about illegally marketing its product as a safer alternative to cigarettes.
The FDA ordered Juul to respond within 15 days with corrective actions and its plan to comply with federal law. It noted that failure to comply could result in fines, seizures or injunction.
"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. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth," Acting FDA Commissioner Dr. Ned Sharpless said in a statement.
The FDA sent a separate letter to Juul "expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding JUUL's outreach and marking practices, including those targeted at students, tribes, health insurers and employers."
The agency requested documents related to marketing, including scientific evidence and data such as consumer perception studies "related to whether these statements and representations explicitly or implicitly convey that JUUL products pose less risk, are less harmful, present reduced exposure, are safer than other tobacco products or that the products are smoking cessation products.
In November, the FDA revealed that vaping had increased nearly 80% among high schoolers and 50% among middle schoolers since a year earlier. Public health experts have said that Juul has largely propelled the rise, commanding about 75% of the e-cigarette market in the United States.
"We believe you have a continuing responsibility to take action to address the epidemic of youth use of your products, some of which appears to have been a direct result of your product design and marketing campaigns, whether or not some of these practices have been discontinued," the FDA's letter to Juul said.
Juul has maintained that its products are intended to convert adult smokers to what it described in the past as a less-harmful alternative. In other communications, the company says it cannot make claims its products are safer, in line with FDA regulations.
"We are reviewing the letters and will fully cooperate," according to a Juul Labs spokesperson.
Calls for action against Juul
Last week, Rep. Raja Krishnamoorthi, chairman of the House Oversight Subcommittee on Economic and Consumer Policy, asked the FDA in a letter to take "appropriate enforcement action" against Juul. He said the agency should "protect the American public from the fraudulent and unapproved medical claims" made by the company.
Krishnamoorthi's letter followed a two-day hearing in July, after which the committee concluded that "JUUL appears to be violating FDA regulations against making unapproved express and implied claims that its product helps users stop smoking cigarettes and is safer than cigarettes."
At the subcommittee hearing in July, several people testified that the company was directly marketing to children in high school, to the Cheyenne River Sioux Tribe and to smoking cessation groups.
On Friday, the US Centers for Disease Control and Prevention announced that the agency is now aware of at least 450 possible cases of severe lung disease that could be caused by vaping across 33 states. There have been at least five deaths across five states -- one each in Illinois, Oregon, Minnesota, Indiana and California -- linked to the illnesses.
After news of additional deaths spread on Friday, US Senate Democratic Whip Dick Durbin called on FDA's Sharpless to act on regulating e-cigarettes and flavors in the next 10 days. Durbin said he would call for Sharpless' resignation if he did not take action.
"As Acting Commissioner of the FDA, you alone have the power to stop this vaping epidemic, which has now reached the point where children and young adults are getting sick and dying," Durbin said in a statement. "If you continue to refuse to do your job -- which is to protect the public health -- then it is time to allow someone else to take the helm."