As such Juul has 15 days to respond to the FDA and set out how it plans to correct its actions and a plan for complying with U.S. laws.
"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."
The FDA has put the industry on notice and warns if the rise in youth e-cigarette use continues - especially through the use of flavors that appeal to kids - the regulator will take even more aggressive action.
In November, the FDA revealed that vaping had increased almost 80% among high schoolers and 50% among middle schoolers since a year earlier.
"These marketing techniques were common and well documented, says Robert Jackler, a researcher at Stanford who studies e-cigarette marketing", writes Sara Harrison for Wired.
The FDA is giving Juul 15 days to respond to the letter and failure to do so can result in a fine, injunctions or seizure of the company's products.
"Juul has maintained that its products are meant to convert adult smokers to what it described in the past as a less-harmful alternative".
The agency mentioned on Monday that the company has and continues to illegally advertise its products to be a safer alternative to traditional cigarettes.
As the Times reported Monday, the letter states that because Juul never received federal approval to promote and sell its vape pens as a healthier alternative to cigarette smoking, it has acted illegal in its marketing campaigns that say just that.
These letters are the latest in a series of actions the agency has taken as part of its continued commitment to providing strong oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS) and the latest development in the FDA's ongoing investigation related to JUUL. Yet, the agency noted, the company has made many unsubstantiated claims along those lines. The FDA's Center for Tobacco Products reviewed Burns's testimony from a July 24-25, 2019 hearing and documents from an inspection of the company's lab and determined that the company's products are within the FDA's jurisdiction.
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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Five deaths have been linked to vaping, and hundreds of people have been hospitalized.
US Senate Democratic Whip Dick Durbin pointed out in a press conference on Monday how Sharpless' predecessor, Dr. Scott Gottlieb, called vaping among youth an "epidemic".