George K last edited by George K
The US Food and Drug Administration has ordered Juul Labs Inc. products to be removed from the US market as the agency issued marketing denial orders for its vaping devices and pods.
"As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action," the FDA said on Thursday.
In a separate statement on Thursday, Juul said it is seeking a stay and will consider appealing the decision.>
After reviewing Juul's applications seeking marketing authorization for its products, the FDA said it determined that the applications lacked "sufficient evidence" regarding the toxicological profile of the products in order to demonstrate that marketing of the products would be appropriate for the protection of the public health.
"This action by FDA reflects the agency's steadfast commitment to carefully evaluating the science to ensure that only those products meeting its rigorous public health standards are granted marketing authorization. FDA has taken the proper steps to protect the health of all Americans," US Health and Human Services Secretary Xavier Becerra said in a statement Thursday.
Juul devices and four types of pods -- tobacco and menthol-flavored -- cannot be sold or distributed, the FDA said, and "retailers should contact JUUL with any questions about products in their inventory." In 2019, the company announced it would stop selling several flavored products and only tobacco and menthol flavors remained for sale.
The FDA added that it reviewed the company's premarket tobacco product applications and determined some of Juul 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 agency's 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.
Renauda last edited by
What has the lady with a guitar photo to do with this?
George K last edited by