Today, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to JUUL Labs Inc. for all their products currently marketed in the U.S. As a result, JUUL must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or the FDA may take enforcement action.
After reviewing JUUL’s applications to FDA seeking marketing authorization for their products, FDA determined that the applications lacked sufficient evidence to demonstrate that marketing of the products would be appropriate for the protection of the public health. Health and Human Services Secretary Xavier Becerra issued the following statement:
“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.”