Juul illegally marketed its e-cigarettes as less harmful than cigarettes, the FDA said in a warning letter.
to CEO Kevin Burns after reviewing testimony from two days of hearings in the U.S. House on Juul in July. FDA investigators found the company broke the law "by selling or distributing them as modified risk tobacco products without an FDA order in effect that permits such sale or distribution."
"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," Acting FDA Commissioner Ned Sharpless"JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth," Sharpless said.
FDA rules require a company to receive regulatory approval before marketing any tobacco product as less harmful than cigarettes. Juul's vaping devices have never been submitted to the FDA for review. The company has 15 days to respond to the agency.sent Monday, the FDA additionally requested more information about the company's marketing practices.
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