The Supreme Court last week rejected a government effort to narrow options for challenging Food and Drug Administration (FDA) denials of applications to market e-cigarettes, including flavored products, reported the Washington Post.
RJ Reynolds, along with several convenience retailers, had sued FDA in the 5th Circuit to challenge FDA's denial of premarket approval applications on Reynolds' Vuse vape products.
The FDA argued that retailers didn’t have the right to sue, and therefore the case had to be argued in D.C. or Reynolds’ home state of North Carolina. The ruling means that retailers can now challenge denials of premarket approval of tobacco products by FDA.
“Congress knows how to limit the scope of a cause of action—in fact, it did so elsewhere in the [Tobacco Control Act],” Justice Amy Coney Barrett wrote for the majority, referring to the law in question in the case. The Court made clear that it is not just the manufacturers who have the legal standing to challenge FDA’s decisions on premarket approval applications for vape products. The ruling grants plaintiffs seeking to challenge FDA decisions more options regarding who can sue and where they can bring those lawsuits.
While the FDA argued that R.J. Reynolds and other e-cigarette manufacturers were “gaming court system rules” by filing the vast majority of product-denial appeals in the U.S. Court of Appeals for the 5th Circuit, based in New Orleans, the Supreme Court rejected that claim.
“There is no question that retailers have a direct interest in decisions on premarket approval applications,” said Doug Kantor, General Counsel at NACS. “We are pleased that the Court recognized retailers’ business needs. And, it is past time for the FDA to finish making decisions on all of these premarket approval applications so that retailers can have clarity and the market for vape products can be cleaned up.”