Court Rules FDA Warning Letter Is Not Final Agency Action

A federal court in Colorado has dismissed as premature a medical provider’s challenge to Food and Drug Administration (FDA) regulations potentially applicable to its medical procedures because the agency had issued only a warning letter against it, and warning letters are not final. Regenerative Sciences, Inc. v. FDA, No. 09-411 (D. Colo., decided March 26, 2010). The court’s analysis of the non-final nature of FDA warning letters may have some relevance in those consumer fraud actions against food makers citing such letters to establish a fact or using them as definitive evidence of wrongdoing or a violation of the law. The agency itself acknowledged that its warning letters do not constitute a determination that a particular statute or regulation applies to the specific circumstances that led FDA to issue the letters, noting “this is a factual issue that cannot be resolved until FDA brings an action against” the letter recipient.