Stakeholders can’t sue FDA over NAC warning letters
Industry stakeholders cannot sue FDA based merely on its positions asserted in warning letters because courts have found such complaints are premature, several lawyers said.
The court decisions put FDA-regulated companies in a difficult spot when they disagree with the agency’s interpretation of law. A case in point is the lingering dispute between FDA and the dietary supplement industry over the legality of NAC (N-acetyl-L-cysteine) in supplements.
In interviews for this story, more than half a dozen lawyers who practice food law said a warning letter is not considered final agency action. The courts would maintain that a lawsuit filed against FDA, based on 2020 warning letters related to NAC, is not ripe for an adjudication, legal experts said.
“It’s hard, if not impossible, to successfully challenge a warning letter,” said Stuart Pape, an attorney in Washington, D.C., who chairs the FDA practice of the law firm Polsinelli. “The courts have consistently held that a warning letter isn’t final agency action, and you can’t get judicial review unless what you’re challenging is final agency action.”
A lawsuit filed today in U.S. District Court requesting a declaratory judgment over the legality of NAC wouldn’t survive a motion to dismiss by the government, according to several of the lawyers.
“It’s our understanding that if we went to court, our only remedy at this point would be to seek a declaratory judgment,” said Steve Mister, president and CEO of Council for Responsible (CRN), who also is a lawyer. “Our attorneys are telling us that we would likely be dismissed for failure to exhaust our administrative remedies, and the court would say this is not a final agency action.”
That reality has put NAC, CBD and other ingredients flagged by FDA in a “regulatory limbo,” said attorney Rend Al-Mondhiry, a partner in the nation’s capital with Amin Talati Wasserman LLP.
Al-Mondhiry expressed skepticism that a regulatory avenue is available through which industry could obtain a timely resolution on the NAC issue.
“To get something done in a timely way, I think the options are—maybe I shouldn’t even say ‘limited’—nonexistent,” she concluded.
Marc Ullman is of counsel to Rivkin Radler LLP, a New York-based law firm. He said firms “are intimidated” into meeting FDA’s “directives” in the warning letters.
“FDA is essentially browbeating people into complying with these directives,” the lawyer said, “and there’s no avenue to challenge them other than saying, ‘No. We’re ignoring you. Sue us.’”
If FDA, in collaboration with the U.S. Department of Justice, has filed a lawsuit over NAC, that would be news to sources contacted for this article.
Lindsay Haake, an FDA spokeswoman, said the agency “does not comment on whether or not it has commenced enforcement actions.”
That doesn’t mean retailers of NAC shouldn’t be concerned about the risks, Ullman cautioned.