The US Food and Drug Administration announced Thursday it had rescinded marketing denial orders for vaping products from Juul Labs Inc., stating it has not yet decided whether the products will ultimately stay on the market. 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.” Juul said Thursday its products will remain on the market during scientific review.
The FDA issued a marketing ban on Juul products back in 2022, including devices and tobacco and menthol-flavored pods. The marketing denial order was stayed weeks later as “scientific issues warranted additional review,” but had not been rescinded. 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.”
US Health and Human Services Secretary Xavier Becerra said in a statement Thursday: “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.”
Michele Mital, acting director of the FDA’s Center for Tobacco Products, said in the agency’s news release: “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. 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 said court decisions since then “establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law,” adding that rescission of the marketing ban “is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied .. The agency’s continued review does not alter the fact that all e-cigarette products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed.”
In a statement, Juul said it looks forward to “re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products.”
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