JUUL Products Can Stay on the Market as Challenge Plays Out
The company is filing an emergency motion with the court.
WASHINGTON, D.C. — Convenience store retailers can continue to sell JUUL vapor products as the company challenges the Food and Drug Administration's (FDA) decision to deny the organization permission to market the products in the United States.
Late Friday, June 24, the United States Court of Appeal for the District of Columbia Circuit granted JUUL Labs Inc. an emergency motion for temporary administrative stay as it prepares to appeal the FDA's ruling.
With the court's ruling, JUUL products can remain on the backbar. As part of its ruling, the three-judge panel set a timeline for the legal challenge:
JUUL's emergency motion: by noon on June 27
The FDA's response: by noon on July 7
Reply: by noon on July 12
On June 23, the agency issued marketing denial orders (MDOs) for all JUUL products. Less than 24 hours after the announcement, JUUL Labs asked the U.S. Court of Appeals for the D.C. Circuit for an emergency administrative stay until it could file a motion for a stay pending review by noon today, June 27.
In issuing the MDOs, the FDA said some of the company's study findings raised concerns due to 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 and precluded the FDA from completing a full toxicological risk assessment of the products named in the company's applications.
JUUL disagreed with the findings, as Convenience Store News reported.
"In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being 'appropriate for the protection of the public health,'" said Joe Murillo, chief regulatory officer at JUUL Labs.
The FDA's decision on JUUL's premarket tobacco applications (PMTAs) comes 18 months after the agency's deadline for all PMTAs for products that fall under the 2016 deeming rule. To date, it has taken action on approximately 99 percent of the nearly 6.7 million products for which PMTAs were received by the Sept. 9, 2020 deadline, including issuing marketing denial orders for more than 1 million ENDS products.
The agency has granted authorization to several major vapor brands, including four NJOY Ace e-cigarette products and two NJOY LLC tobacco-flavored Daily disposable electronic cigarettes; and R.J. Reynolds Vapor Co.'s Vuse Solo and certain Vuse Ciro and Vuse Vibe products.
However, it issued MDOs to Fontem US LLC for several myblu products in April.