The Tenth Circuit Court of Appeals, in an opinion issued late last week, ruled in favor of the Food and Drug Administration (FDA) in rejecting a complaint from Lystin, LLC, a pet food manufactuerer. The plaintiff originally argued that the agency’s “alleged ‘nationwide zero-tolerance standard for Salmonella presence in pet food that is unsupported by science and ultra vires of powers properly delegated to it by Congress.'”
The case concerns the FDA’s Compliance Policy Guide concerning salmonella in animal food. The guide, which the opinion said is non-binding, provides guidance for agency staff as to what constitutes adulterated food and what measures can be taken to prevent or eliminate adulteration.
According to the opinion, Lystin alleged that the Colorado Department of Agriculture adopted the definition of adulteration, which it says is contrary to other laws which state that “a naturally occurring substance will not render a product adulterated unless the quantity of the substance is injurious to health.” In 2018, the Colorado agency detected salmonella in a sample of Lystin food, and brought charges against Lystin, the filing stated; Lystin is said to have refused a recall and as a result the FDA issued a public warning.
The panel rejected Lystin’s arguments and found that the FDA took no final agency action, and such there is nothing the court can review. Lystin had alleged that the agency took a final action by partnering with the Association of American Feed Control Officials to create “shadow regulation,” an argument that the court below found to be unsupported. The court also rejected arguments that the FDA took action by issuing a warning letter to Lystin.
Lystin is represented by the Joseph A. O’Keefe Law Office and Sodomsky & Nigrini.