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FDA suspends Juul's U.S. ban, requires additional review

FDA suspends Juul's U.S. ban, requires additional review

2022-07-11

The FDA announced on Twitter that the U.S. Food and Drug Administration temporarily halted its ban on Juul Labs products, while the e-cigarette maker appealed the agency's decision.


On June 23, the FDA ordered Juul Labs to remove its e-cigarettes from U.S. stores, saying the e-cigarette maker had submitted insufficient evidence that they were unfit to protect public health.


A federal appeals court then granted Juul Labs an emergency stay order to give a judge time to assess the merits of Juul's appeal. The e-cigarette company separately asked the FDA to keep its own order during the appeal.


In a series of tweets, the FDA said it had determined that the Juul application had unique scientific issues that required additional review. The agency stressed that the suspension of the suspension will not be revoked for the Marketing Denial Order (MDO).


According to the Wall Street Journal, the FDA initially rejected Juul's request for a stay, prompting Juul to seek a stay in court.


In its court filing challenging the FDA ruling, Juul said the agency ignored more than 6,000 pages of data the company submitted to the FDA about the aerosols users inhaled. Juul also said the FDA's decision was influenced by political pressure.


The FDA's marketing rejection of Juul came as a surprise to many in the vaping industry, especially after vaping products made by rivals such as Reynolds America Inc. and NJOY Holdings received marketing authorization. A pioneer in the vaping space and backed by Altria, a company with decades of regulatory compliance experience, Juul Labs appears to meet the agency's stringent standards better than most.


Public health advocates criticized the shelving of the FDA ruling.


Matthew L. Miles, president of the Campaign for Tobacco Free Kids, said in a statement.


“This decision will allow the brands most responsible for creating and fueling the youth vaping epidemic to continue to be sold, at least for now. We are nearly 10 months past the court-ordered FDA deadline to complete a review of vaping marketing applications, and The FDA cannot afford more delays in removing child-friendly products from the market."


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