The U.S. Food and Drug Administration has ordered Juul products removed from the U.S. market because the agency issued marketing denial orders for its vaping devices and pods.
“As a result, the company must stop selling and distributing these products. Additionally, those currently on the U.S. market must be removed or face enforcement action,” the FDA said Thursday.
Juul devices and four types of pods — tobacco and menthol flavored — cannot be sold or distributed, the FDA said.
The agency said it had reviewed the company’s premarket tobacco product applications and determined that the findings of the tJuul Labs study contained “insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaking from the company’s proprietary e-liquid pods – which have not been adequately treated.”
“The FDA is responsible for ensuring that tobacco products sold in this country meet the standards set by law, but the responsibility for demonstrating that a product meets those standards ultimately rests with the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products, in the press release. “As with all manufacturers, JUUL has had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company has not provided this evidence and instead left us with important questions. data necessary to determine the relevant health risks, the FDA issues these marketing denial orders.”
FDA action focuses on importation, distribution, and sales, not individual use, and it “cannot and will not object to possession or use by a consumer individual of JUUL products or any other tobacco product”.
CNN reached out to Juul for comment but did not immediately respond.