The Food and Drug Administration is ordering Juul Labs Inc. to stop selling and distributing products in the U.S.
The FDA said Juul has not provided "sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health."
The products include the Juul device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol-flavored pods at nicotine concentrations of 5.0% and 3.0%, the FDA said.
“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.
The FDA's restriction applies to commercial distribution and retail sales. The FDA says it cannot and will not enforce the order on individuals who use Juul products.
Juul Labs Inc. said in a statementon Thursday, "We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency. In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being 'appropriate for the protection of the public health.'"
