The agency is contacting manufacturers directly and holding them accountable, Gottlieb said. “We need to examine all the available information to understand why kids are finding these products so appealing and address it,” he said. Part of that initiative included an official request for information from the FDA directly to Juul Labs, requiring the company to submit documents to help the FDA better understand the reportedly high rates of youth use and the youth appeal of these products, Gottlieb said. The agency plans to send similar letters to other manufacturers, and companies that don’t comply will be in violation of the law and subject to enforcement, he said.
The FDA will take additional enforcement actions focused on companies that it thinks are marketing products in ways that are misleading to kids. Gottlieb said he would elaborate in the coming weeks.