JUUL Labs Inc. can no longer sell or distribute any of its products marketed in the United States after receiving Marketing Denial Orders (MDOs) from the U.S. Food and Drug Administration (FDA).
“Today, the U.S. Food and Drug Administration issued [MDOs] to JUUL Labs Inc. for all of their products currently marketed in the United States,” the FDA announced in a release Thursday. “As a result, the company must stop selling and distributing these products.”
JUUL is no longer allowed to sell or distribute the Virginia Tobacco or Menthol flavored pods, which were offered with nicotine concentrations of three and five percent, in addition to the JUUL device itself, which vapers use to inhale the contents of the pods.
FDA Commissioner Robert M. Califf, M.D stated:
Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards. The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.
The FDA said that a review of JUUL Labs’ premarket tobacco product applications (PMTA) “lacked 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.”
PMTAs are required to include scientific data showing that a particular “product is appropriate for the protection of public health.”
The FDA said that some of the findings in a study associated with JUUL’s PMTA “raised concerns due to insufficient and conflicting data” that was not “adequately addressed,” which stymied the agency’s abilities to complete “a full toxicological risk assessment of the products.” Concerns of insufficient and conflicting data included “genotoxicity and potentially harmful chemicals leaching from JUUL pods.
Moreover, the FDA submitted that it did not receive “clinical information to suggest an immediate hazard,” derivative of product use, but emphasized the MDOs stemmed from the lack of sufficient data to make a “toxicological risk assessment of the products.”
Consumers who already have JUUL products are not affected by the FDA’s MDOs and their use or possession of the devices will not be restricted.