CINCINNATI (CN) — A Kentucky-based e-cigarette retailer lacks standing to challenge an FDA deadline for regulatory filings on vapor and nicotine products because the deadline was issued by a federal judge, not the government, the Sixth Circuit held Monday.
Vapor Stockroom, located in Lexington, Kentucky, argued before a three-judge panel in August that the May 2020 deadline established after a group of public health organizations sued the Food and Drug Administration in Maryland federal court was arbitrary and violated its rights under the Administrative Procedure Act.
The deadline was eventually extended to September as a result of the Covid-19 pandemic, but Vapor Stockroom claimed it lacked sufficient guidance from the FDA to complete its product applications in time. Failure to comply with regulatory filings regarding a tobacco product’s ingredients and health risks can result in civil and criminal penalties to the manufacturer.
U.S. District Judge Karen Caldwell, an appointee of George W. Bush, sided with the government and ruled that Vapor Stockroom could not sue the FDA because any injury caused by the accelerated deadline was the result of action by the federal judge in Maryland.
A three-judge panel of the Sixth Circuit agreed with Caldwell in a brief, 11-page per curiam opinion on Monday.
“The Maryland court’s injunction was not an action by the FDA – it was an action taken by the court itself,” the ruling states. “The Maryland court is an independent third party that is not part of the present suit. Vapor Stockroom cannot sue the FDA to attack the Maryland court’s decision.”
Vapor Stockroom argued that a brief from the FDA filed in the Maryland case was a sufficient “motivating factor” in the court’s decision to render the accelerated deadline a final agency action, but the panel was unconvinced.
“Although courts are aided by the parties’ briefings,” the opinion states, “a court’s resolution of a contested issue is ultimately guided by the court’s own view of the law, the facts, or the exercise of discretion.”
The judges similarly rejected Vapor Stockroom’s argument regarding a 2015 Sixth Circuit ruling in Parsons I, a case involving the Juggalos, a group of fans of the music group Insane Clown Posse.
That decision gave the Juggalos standing to sue the Department of Justice for its decision to label the group a gang even though their alleged injuries had been caused by local law enforcement, but the panel was quick to point out the differences between the cases.
“The relationship between federal and local law enforcement agencies is quite distinct from the relationship between courts and litigants,” the ruling states. “Local law enforcement agencies may feel compelled to follow the lead of federal law enforcement and take action pursuant to information provided by federal law enforcement. But courts are not similarly beholden to litigants.”
The panel was comprised of Senior U.S. Circuit Judge John Rogers and U.S. Circuit Judge Raymond Kethledge, both George W. Bush appointees, as well as U.S. Circuit Judge John Nalbandian, an appointee of President Donald Trump.