FDA Raps JUUL on Knuckles for School Talk, Marketing Claims

FDA calls out Juul for promoting vaping as safer than cigarettes

FDA calls out Juul for promoting vaping as safer than cigarettes

The Food and Drug Administration on Monday came out swinging at e-cigarette giant Juul over a variety of its unproven safety claims and startling marketing practices-most notably saying without evidence that its products are safer than smoking traditional cigarettes and giving presentations directly to kids in schools-in at least one alleged case, without teachers present or parental consent.

The FDA notes that Juul advertised its products as a "modified risk tobacco product" wherein the firm claims in multiple instances that its product is safer than regular cigarettes.

'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 Ned Sharpless, the FDA's acting head.

The FDA sent a separate letter to Juul "expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding JUUL's outreach and marking practices, including those targeted at students, tribes, health insurers and employers". The FDA said it found that Juul illegally sold or distributed its products as "modified risk tobacco products without an FDA order in effect that permits such sale or distribution". The FDA warning comes after the House Committee on Oversight and Reform held hearings on Juul's role in the youth nicotine epidemic in July.

According to federal law, companies like Juul are not allowed to market products as safer than cigarettes without proving these claims to the FDA. The agency further asks JUUL why it uses a nicotine concentration of 5% in its products, which the agency is concerned could potentially increase their addictiveness.

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The other was sent to JUUL CEO Kevin Burns "to request documents and information. regarding JUUL's marketing, advertising, promotional, and education campaigns, as well as certain product development activity".

From March to May 2018, JUUL used youthful posts on Instagram to promote e-cigarettes and associated products to teens, one study found, supporting concerns that the company was looking to appeal to a younger crowd. The company has 15 days to respond to the warning letter and says it will fully cooperate with the FDA.

Kelly Henning from Bloomberg Philanthropies and former youth e-cigarette user Phillip Fuhrman are live from NY to explain the action they're taking to address this public health crisis.

JUUL "was much safer than cigarettes" and that "FDA would approve it any day".

"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."

On Tuesday, Kansas health officials confirmed that state's first death tied to a vaping-related lung illness, following similar deaths in Minnesota, Indiana, Oregon, Illinois and Los Angeles. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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