Juul devices and four types of pods — tobacco and menthol-flavored — cannot be sold or distributed, the FDA said.
The agency said it reviewed the company’s premarket tobacco product applications and determined tJuul Labs’ study findings had “insufficient and conflicting data — including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods — that have not been adequately addressed.”
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products, in the news release. “As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
The FDA action focuses on importation, distribution and sales, not individual use, and it “cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.”
CNN has contacted Juul for comment but did not immediately hear back.