As stated in the warning letter, the FDA has determined that JUUL has marketed its products as modified risk tobacco products without an appropriate FDA order in effect. FDA Commissioner Ned Sharpless mentioned in a statement that Juul still should have sought FDA approval prior to the nationwide sale and distribution of its products.
The letters, dated and announced on Monday, are the latest in an aggressive crack down by the agency on JUUL's marketing to kids, with one focused on marketing and advertising and the other on issues raised at recent Congressional hearings.
"We remain committed to using all available tools to ensure that e-cigarettes and other tobacco products aren't being marketed or sold to kids", Sharpless said.
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". Failure to ensure compliance with FD&C Act may result in the FDA initiating further action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Tony Abboud, executive director of the Vapor Technology Association, has argued that science demonstrates that flavors are not the reason youth illegally use vaping products, but science shows that flavors play a "critical role" in helping adult smokers quit traditional cigarettes. The letter specifically refers to Juul's "Make the Switch" campaign that conveys the idea that switching to JUUL is a safer alternative to cigarettes, in that using JUUL products poses less risk or is less harmful than cigarettes. "Our concern is amplified by the epidemic rate of increase in youth use of ENDS products, including JUUL's products, and evidence that ENDS products contribute to youth use of, and addiction to, nicotine, to which youth are especially vulnerable". The FDA also is requesting information about the company's marketing practices, particularly those targeting students, tribes, health insurers and employers.
From March to May 2018, JUUL used youthful posts on Instagram to promote e-cigarettes and associated products to teens, one study found, supporting concerns that the company was looking to appeal to a younger crowd.
Kelly Henning from Bloomberg Philanthropies and former youth e-cigarette user Phillip Fuhrman are live from NY to explain the action they're taking to address this public health crisis.
Villa goes on to give Juul just 15 days to submit a written response describing its "corrective actions" in detail.
A spokesperson for Juul said the company intends to "fully cooperate" with regulators.
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. This ought to be closely regulated by the Food and Drug Administration.