FDA Says Juul Made Modified Risk Claims, Asks For Youth Outreach Docs

FDA cited Juul Labs for selling and distributing its electronic nicotine delivery system (ENDS) products as modified risk tobacco products without FDA approval, in a warning letter to Juul CEO Kevin Burns Monday (Sept. 9). The agency also sent a separate 12-page letter outlining concerns with the company’s marketing and outreach efforts as highlighted in a House oversight subcommittee hearing in July, and FDA asked the company to provide myriad documents detailing such efforts. The warning letter and the document...