Does Sackett foreshadow the end of non-reviewability for FDA warning letters?

Abstract

FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedure Act (APA). The Supreme Court's analysis in Sackett v. EPA suggests the legal tides might be shifting. In Sackett, the Court held that an Environmental Protection Agency (EPA) compliance order was considered final agency action subject to judicial review under the APA. While there are differences between compliance orders and warning letters, both inform regulated parties of non-compliance with federal law and are highly valued measures of inducing "voluntary compliance." Sackett should provide precedent for future litigation over judicial reviewability of warning letters.