Vaping market leader Juul Labs received a harsh warning today from federal health officials over claims that its e-cigarette products are less harmful than conventional tobacco use. In a letter to Juul CEO Kevin Burns, the Food and Drug Administration’s Office of Compliance and Enforcement threatened the company with fines and even the seizure of its products if it doesn’t correct its marketing.
“It is your responsibility to ensure that your tobacco products, all related labeling and advertising, and all other activities by JUUL directed to consumers, such as in any media in which you advertise and any retail establishments, comply with each applicable provision of the FD&C Act [Federal Food, Drug, and Cosmetic Act] and FDA’s implementing regulations,” wrote Anthony Villa, the office’s senior regulatory counsel. “Failure to ensure compliance with the FD&C Act may result in FDA initiating further action, including, but not limited to, civil money penalties, seizure, and/or injunction.”
Villa goes on to give Juul just 15 days to submit a written response describing its “corrective actions” in detail. The FDA warning comes after the House Committee on Oversight and Reform held hearings on Juul’s role in the youth nicotine epidemic in July.
Reached for comment, a spokesperson for Juul said the company is reviewing the letter and plans to “fully cooperate.”
You can read the full letter here.