"The FDA said it will conduct further reviews into the Juul applications.
Many health and anti-vape groups had been pressuring the FDA to reject any PMTA applications by Juul for months. In fact earlier this year, several groups joined forces and sent a letter to the FDA urging it to take action on the outstanding PMTAs and deny any applications for flavoured vaping products.
Entities such as the American Lung Association (ALA) and the Campaign for Tobacco-Free Kids said they were “deeply disappointed” that the FDA was still studying a percentage of the applications, including Juul’s. ECigIntelligence had revealed that the Campaign for Tobacco-Free Kids had gone as far as threatening to take the agency to court if it did not “immediately clarify” the timeline and reason for these delays.
Finally last month, the FDA issued Juul an MDO. The decision applied to “all of their products currently marketed in the United States,” and would have forced the manufacturer to completely exit the US 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,” stated FDA Commissioner Robert M. Califf.
Juul denied claims that it had not submitted enough documentation
However in response to this, Juul immediately filed an emergency motion at a federal appeals court asking the court to take a stance against an “extraordinary and unlawful action” by the FDA. A three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit ruled in favour of Juul, allowing the products to remain on the market.
In issuing the MDOs, the FDA accused Juul of failing to submit enough information in its applications, leaving regulators with many questions. However during the court filing, Juul revealed that it had submitted a 125,000-page application to the FDA nearly two years ago, adding that the application included several studies to evaluate the health risks among Juul users.
Subsequently, the FDA has just announced it is suspending its decision in order to conduct further reviews. “FDA is reviewing the marketing denial orders it issued to JUUL because in the course of reviewing litigation briefing materials the agency determined that there are scientific issues unique to this application that warrant additional review,” said an FDA spokesperson as quoted by Filter. The spokesperson added that because Juul’s “products do not have marketing authorization, [the company] cannot legally market, ship or sell their products,” and “the stay does not change this.”
“With this administrative stay from the FDA now in place, we continue to offer our products to adult smokers while we pursue the agency’s internal review process,” Joe Murillo, the chief regulatory officer at Juul Labs, said in a statement. “We remain confident in the quality and substance of our applications and believe that ultimately we will be able to demonstrate that our products do in fact meet the statutory standard of being appropriate for the protection of the public health. We now look forward to re-engaging with the FDA on a science- and evidence-based process to pursue a marketing authorization for JUUL products.”
Filter highlighted that that the FDA decision could be translated in one of two ways: “Either the FDA is looking to bolster its initial MDO; or it believes it may have erred and could release a full rescission, placing Juul once again in scientific review.”
The content excerpted or reproduced in this article comes from a third-party, and the copyright belongs to the original media and author. If any infringement is found, please contact us to delete it. Any entity or individual wishing to forward the information, please contact the author and refrain from forwarding directly from here.
