FDA questions claims such as Juul is ‘much safer than cigarettes’ and the ‘FDA would approve it any day’
MONDAY, Sept. 9, 2019 (HealthDay News) — A warning letter has been sent to Juul Labs Inc. about illegal claims that its electronic cigarettes are safer than tobacco cigarettes, including statements made in a presentation to students, the U.S. Food and Drug Administration says.
The FDA’s warning letter refers to several statements, including those discussed in testimony from a July 2019 Congressional hearing. According to that testimony, a Juul representative speaking with students in a school presentation stated that Juul “was much safer than cigarettes,” that the “FDA would approve it any day,” and that the device was “totally safe.” 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.
The FDA warning also cited a letter from Juul’s CEO that appeared on the company’s website and in an email sent to a parent who complained that the company had sold products to her child. The CEO’s letter stated: “[Juul’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.” The FDA also noted a presentation to the Cheyenne River Sioux Tribe in South Dakota. In that presentation earlier this year, Juul said its device is “a smart, really well-thought-out alternative to smoking” that will improve “the lives of the world’s one billion adult smokers.”
The FDA also asked Juul to explain why it uses nicotine salts — which were said during the Congressional hearing to mask the harshness of nicotine. The company was also asked to explain why its products have a nicotine concentration of 5 percent, which the FDA said could increase their addictiveness.
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