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FDA Warns Vaping Company Juul Labs For Illegal Marketing

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The US Food and Drug Administration issued a warning letter to vaping company Juul Labs Inc. for marketing unauthorized modified risk tobacco products to consumers, including a presentation given to youth at a school.

FDA said its 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," said Acting FDA Commissioner Ned Sharpless, M.D.

"JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth."

FDA requires 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 FDA has requested that Juul provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), including its plan to prevent the same or similar violations.

"In addition, we're troubled about several issues related to JUUL's outreach and marketing practices that came to light in a recent Congressional hearing. We will continue to scrutinize tobacco product marketing and take action as appropriate to ensure that the public is not misled into believing a certain product has been proven less risky or less harmful."

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