JUUL Labs Inc. can no longer sell or distribute any of its products marketed in the United States after receiving Market Refusal Orders (MDOs) from the United States Food and Drug Administration (FDA).
“Today, the United States Food and Drug Administration released [MDOs] to JUUL Labs Inc. for all of their products currently marketed in the United States,” the FDA said in a statement Thursday. “As a result, the company must stop selling and distributing these products.”
JUUL is no longer authorized to sell or distribute Virginia Tobacco or Menthol flavored pods, which were offered in three and five percent nicotine strengths, in addition to the JUUL device itself, which vapers use to inhale the contents of the pods.
FDA Commissioner Robert M. Califf, MD said:
Today’s action is further progress in the FDA’s commitment to ensuring that all e-cigarette and e-nicotine delivery system products currently marketed to consumers meet our public health standards. The agency has devoted significant resources to reviewing products from companies that represent the bulk of the US market. We recognize that these make up a significant portion of the products available and many of them have played a disproportionate role in increasing youth vaping.
The FDA said a review of JUUL Labs’ premarket tobacco product applications (PMTAs) “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing the products would be appropriate for the protection of public health.” .
PMTAs must include scientific data showing that a “particular product is appropriate for the protection of public health”.
The FDA said that some of the findings of a study associated with JUUL’s PMTA “raised concerns due to insufficient and conflicting data” that were not “adequately addressed”, which hampered the agency’s ability to complete “a complete assessment of the toxicological risks of the products. Concerns about insufficient and conflicting data included “genotoxicity and potentially harmful chemicals leaking from JUUL pods.
Additionally, the FDA argued that it had not received “clinical information suggesting immediate harm” derived from the use of the product, but pointed out that the MDOs stemmed from the lack of sufficient data to make an assessment. “assessment of the toxicological risks of products”.
Consumers who already own JUUL products are not affected by the FDA MDOs and their use or possession of the devices will not be restricted.