Lystn, LLC (also doing business as Answers Pet Food; Lystn) is a pet food manufacturer of raw pet food. Lystn has been in a battle with FDA and the Colorado Department of Agriculture (CDA) since 2018 when CDA collected a sample of Lystn’s Straight Beef Formula for Dogs that allegedly tested positive for Salmonella and Listeria monocytogenes. On January 9, 2019, FDA issued a Public Warning Notice cautioning consumers about Lystn’s Straight Beef Formula for Dogs because, according to FDA, the product represented a serious threat to human and animal health due to the presence of Salmonella.
CDA pursued action against the Company in the Colorado Office of Administrative Courts based on the positive sample. Lystn attributed CDA’s enforcement action to FDA, alleging that FDA “through the CDA, ha[d] chosen to prosecute [the Company] for alleged violations” of FDA’s compliance policy guide, Salmonella in Food for Animals (CPG). This CPG states that “FDA considers a pet food to be adulterated under . . . 21 U.S.C. 342(a)(1) when it is contaminated with Salmonella and will not subsequently undergo a commercial heat step or other commercial process that will kill the Salmonella” and identifies criteria for determining whether such pet food should be subject to seizure. The Association of American Feed Control Officials’ (AAFCO) model bill and regulations and the CDA definition of “adulteration” mirror, or are similar to, FDA’s definition of “adulteration” in the CPG.
In July 2019, Lystn sued FDA, AAFCO, the CDA, three CDA employees, and HHS, in the U.S. District Court for the District of Colorado seeking a declaratory judgment that Lystn had been denied its due process rights and an injunction against FDA and AAFCO from applying and enforcing the CPG against Lystn. Specifically, Lystn sought to enjoin FDA and AAFCO from pursuing any pending enforcement action based on the CPG, preventing the reintroduction of similar CPGs, and expunging all claims and references related to Lystn’s distribution of an adulterated product related to the CPG. Defendants moved to dismiss plaintiff’s action alleging lack of subject matter jurisdiction (Federal and State defendants) and personal jurisdiction (AAFCO).
The Court granted all motions to dismiss. It dismissed the action against federal defendants because, according to the Court, the CPG does not constitute final agency action. Instead, the CPG “simply provides information to staff members concerning the interpretation of 21 C.F.R. § 342(a)(1)” to determine if administrative actions are necessary; the CPG does not create a legal right, instead “FDA’s enforcement power stems from 21 U.S.C. § 334.” The Court compared FDA’s public warning to a warning letter, which, as the Court noted does not constitute final agency action either.
Plaintiff’s argument that CDA’s enforcement action was a “thinly-veiled enforcement attempt by . . . FDA” because FDA compels states regulatory agencies to enforce the CPG (a “shadow regulation”) in exchange for FDA funding, also failed because, according to the Court, Plaintiff did not provide evidence that CDA’s action was at the behest of FDA. Moreover, even if it had done so, CDA’s acts of collecting samples and initiation of an investigation did not constitute final agency action.
The action against the State Defendants also was dismissed because the Administrative Procedure Act (APA) does not create a private cause of action against State Agencies. Plaintiff claimed that the State agencies were a vehicle of FDA, but the Court determined that there was insufficient evidence of a connection between the State Agencies and FDA to create subject matter jurisdiction. Thus, the State agencies could not be sued for a violation of the federal APA.
The Court dismissed the case with prejudice. As suggested by the title, this action concerned a company suing FDA pre-enforcement, not a company defending against FDA’s final action.