The U.S. Food and Drug Administration admonished the electric cigarette company Juul Labs last week for claims that its products are safer than conventional cigarettes.
In a letter dated September 9, the FDA warned the company over its assertions that the Juul is “much safer than cigarettes,” and that the “FDA would approve it any day,” among other claims that the FDA says it didn’t authorize.
The agency said it determined that the company claimed, in presentations to students made by Juul representatives, that its e-cigarettes constituted “modified risk tobacco products without an FDA order in effect that permits such sale or distribution.”
“Referring to your [electronic nicotine delivery system, or “ENDS,”] 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,” the letter said. “Our concern is amplified by the epidemic rate of increase in youth use of ENDS products, including JUUL’s products, and evidence that ENDS products contribute to youth use of, and addiction to, nicotine, to which youth are especially vulnerable.”
The FDA asked Juul for a written response to the letter within 15 days