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

By Beth Wang
September 10, 2019 at 2:29 PM
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...


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