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FDA warns Juul about marketing practices

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FDA warns Juul about marketing practices
September 9, 2019

The FDA has issued a warning letter to Juul Labs for marketing its products as modified risk tobacco products, without an appropriate FDA order in effect, through labeling, advertising and other activities directed to consumers, including a presentation given to youth at a school, according to an agency press release.

“Regardless of where products like [electronic] 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. Juul has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” Ned Sharpless, MD, acting FDA commissioner, said in the release. “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. We remain committed to using all available tools to ensure that e-cigarettes and other tobacco products aren’t being marketed or sold to kids. We’ve also put the industry on notice: If the disturbing rise in youth e-cigarette use continues, especially through the use of flavors that appeal to kids, we’ll take even more aggressive action.”

Unauthorized claims
In the letter, the FDA states that Juul’s labeling, advertising or other activities directed at consumers represent or would be reasonably expected to result in consumers believing that Juul’s products present a lower risk for tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products; contain a reduced level of a substance or present a reduced exposure to a substance; and/or do not contain or are free of a substance or substances.

Specifically, the warning letter identifies several statements discussed in testimony from a July congressional hearing on Juul, according to the FDA release. In that testimony, a Juul representative speaking with students at his presentation in a school stated that:

Juul “was much safer than cigarettes” and that “FDA would approve it any day.”
Juul was “totally safe.”
A student “should mention Juul to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use.”
“FDA was about to come out and say [Juul] was 99% safer than cigarettes ... and that ... would happen very soon.”
 
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