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FDA Warns Juul About Illegal Marketing Claims

10 September 2019

The FDA is putting the pressure on Juul Labs.

The Food and Drug Administration (FDA) is taking e-cigarette giant Juul to task for violating federal regulations with its marketing.

"Referring to your ENDS [electronic nicotine delivery system] products as "99% safer" than cigarettes, "much safer" than cigarettes, "totally safe", and "a safer alternative than smoking cigarettes" is particularly concerning because these statements were made directly to children in school".

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The letter indicates the FDA has determined that the San Francisco-based company, a top maker of electronic nicotine delivery systems, has marketed its products as modified risk tobacco products, that is, as a safer alternative to traditional cigarette smoking, without FDA approval.

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.

"We believe you have a continuing responsibility to take action to address the epidemic of youth use of your products, some of which appears to have been a direct result of your product design and marketing campaigns, whether or not some of these practices have been discontinued", the FDA's separate letter to Juul said.

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"We are reviewing the letters and will fully cooperate", according to Ted Kwong, a Juul Labs spokesperson. "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".

E-cigarettes have been on the US market for more than a decade, but the FDA didn't gain the authority to regulate them until 2016.

This warning also came after the FDA discovered over 400 cases of lung disease linked to vaping, including five potential deaths, per the New York Times. The industry is under mounting scrutiny due to a surge in teenage vaping and recent deaths that public-health officials have connected to inhaling vapor from e-cigarettes. Numerous samples contain vitamin E acetate that experts said could cause lung injury. The letter also points to some copy on the Juul website in which CEO Kevin Burns states that Juul's vape pen technology "deliver [s] smokers the satisfaction that they want without the combustion and harm associated with it".

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After the seminar, Caleb said he approached the Juul rep and told him that he had a friend struggling with a nicotine addiction. "With respect to our work to tackle the youth e-cigarette epidemic, we remain committed to our oversight of e-cigarettes and to keeping them out of the hands of youth". In the past year, researchers have published several papers analyzing Juul's use of "nicotine salts", a formulation which allows users to inhale higher levels of nicotine with reduced throat harshness.

FDA Warns Juul About Illegal Marketing Claims