Kevin Burns, the CEO of vaping company Juul has received a warning letter from the U.S. Food and Drug Administration (FDA). 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.
Further, the letter identifies the company’s violations, including,
“FDA has determined that JUUL adulterated its products . . . by selling or distributing them as modified risk tobacco products without an FDA order in effect that permits such sale or distribution.”
The letter further indicates,
“JUUL has marketed its ENDS products as modified risk tobacco products because JUUL’s labeling, advertising, and/or other actions directed to consumers (examples of which are referenced above), represent, or would be reasonably expected to result in consumers believing, that the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products; contain a reduced level of a substance or present a reduced exposure to a substance; and/or do not contain or are free of a substance or substances.”
The FDA informed Burns to immediately correct the violations referenced in the letter, to the extent he has not already done so.
Ned Sharpless, the Acting FDA Commissioner, made several comments in a separate statement,
“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.
In addition to facing scrutiny from the FDA, Juul has also facing litigation. For example, North Carolina is suing the company for targeting youth and deceptive marketing practices. The state’s Attorney General Josh Stein announced the lawsuit in May.
“As a result of Juul's deceptive and unfair practices, thousands of North Carolina kids are at risk of addiction to nicotine. Juul must be stopped from spreading this disease any further and must pay for its violations of the law.”
“I'm taking this action today to keep these products out of kids' hands, to keep the vapor out of their lungs and to keep the poison out of their brains.”