The U.S. Food and Drug Administration has issued a warning letter to Juul Labs for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising and/or other activities directed to consumers, including a presentation given to youth at a school.
The agency also sent a letter to the company expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding Juul’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers.
“Regardless of where products like e-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,” said Acting FDA Commissioner Ned Sharpless.
The FDA has requested that Juul provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the Federal Food, Drug and Cosmetic Act, including its plan to prevent the same or similar violations.