FDA tells Juul to stop reduced risk marketing of e-cigarettes

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The FDA is putting the pressure on Juul Labs. During the presentation, the representative told students the company's product was "totally safe."

In letters to the vaping giant on Monday, the FDA ordered Juul to stop making unproven claims to children and adults that its vaping devices are safer than cigarettes.

Last week, Rep. Raja Krishnamoorthi, chairman of the House Oversight Subcommittee on Economic and Consumer Policy, asked the FDA in a letter to take "appropriate enforcement action" against Juul.

The in-school presentations central to the FDA's latest concerns came to light during a Congressional hearing held July 24 and 25, titled "Examining JUUL's Role in the Youth Nicotine Epidemic".

"Juul has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth", FDA acting commissioner Ned Sharpless said in a statement.

The FDA's warning letter said the testimony showed that Juul marketed its vaping products as "modified risk tobacco products" - meaning the company included claims that the products "present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products".

The Juul rep also urged a student to mention Juul to a nicotine-addicted friend "because that's a safer alternative than smoking cigarettes, and it would be better for the kid to use", according to the FDA.

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A spokesperson for Juul Labs says the company is reviewing the letters and will fully cooperate. "Witnesses testified, for example, that JUUL advertising saturated social media channels frequented by underage teens and that JUUL used influencers and discount coupons to attract new customers". He said the agency should "protect the American public from the fraudulent and unapproved medical claims" made by the company.

Federal and state health officials are investigating a number of mysterious deaths from illnesses that have been connected to use of vaping devices.

The FDA considers youth vaping rates to be at "epidemic" levels.

The reprimand could foreshadow a tough road for Juul's efforts to gain FDA clearance to continue selling its products, which all e-cigarette makers must do starting next year. Use of e-cigarettes among middle and high school students rose from 2.1 million in 2017 to 3.6 million in 2018, according to the Centers for Disease Control.

"That was his word, and it is an epidemic, and why the FDA refuses to act, I cannot answer", Durbin said during the press conference.

The letter also criticizes the company for apparently turning over more documents to congressional investigators than to the agency "despite previous document requests from FDA". E-cigarettes generally heat liquid containing nicotine.

The CDC advises anyone who does use e-cigarette products and experience symptoms like those reported, seek medical care promptly.

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