The FDA Is in the Doghouse


An unusual pet food case filed this summer in the District Court of Colorado has a pet food manufacturer as the plaintiff rather than a defendant. Lystn, LLC v. FDA, No. 1:19CV01943 (D. Colo. July 5, 2019).

There have been numerous reports of lawsuits involving allegedly contaminated pet food filed against pet food manufacturers or distributors by pet owners claiming that they were deceived by pet food labels and suffered harm either as a result of paying a premium for the food or because their pets were sickened by the food. In contrast, on July 5, 2019, a raw pet food company, Lystn, LLC, brought a civil action against the FDA seeking declaratory and injunctive relief. The complaint challenges the FDA’s ability to enforce what Lystn characterizes as “a 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.”


Lystn manufactures and distributes raw pet food with a “farm to bowl” philosophy. Instead of using high heat and pressure or irradiation to control bacteria, Lystn limits the presence of salmonella and other bacteria in its raw pet food products through the use of “a science and time proven alternative approach [of] fermentation and Hurdle Technology and proprietary processes.” Lystn claims that through these alternative processes, the bacteria levels will “not ordinarily render [the food] injurious to health.” Lystn uses fermentation because it claims that high heat and traditional forms of processing “denature [the] proteins” found in the food.

Congress passed 21 U.S.C. § 2102, “Ensuring the safety of pet food,” following a 2007 pet food crisis, that implicated the health and safety of pets, as well as the human food supply through animal feed. Among other things, this statute mandated the creation of regulations for pet food processing standards.

Lystn, LLC v. FDA

Lystn alleges that despite this specific law requiring the FDA to conduct formal rulemaking relative to pet food and animal feed, little has changed. Its complaint states that, “The FDA still has not conducted formal rulemaking, [and] is still relying upon disfavored (and nonbinding) desk policies to enforce a zero-tolerance, ‘Nonbinding’ guidance policy.”

Lystn alleges that rather than go through the time-consuming, formal rulemaking process, the FDA is regulating the pet food industry through “illegal shadow regulations.” Lystn’s complaint states, “the FDA did not let a little thing like [Administrative Procedure Act] compliance temper its zeal for banishing Salmonella from pet food completely – and attempting to put [Lystn] (and the whole category of raw natural pet food) out of business without any democratic or judicial check.”

 The complaint alleges that the FDA is working in concert with the Association of American Feed Control Officials (AAFCO) and AAFCO’s member states to illegally enforce the FDA’s nonbinding zero-tolerance guidance banning all serotypes of salmonella in any amount whatsoever from pet food. See FDA’s Compliance Policy Guide Sec. 690.800, Salmonella in Food for Animals (the Guidance). Lystn alleges that science does not back up the claims that all types of salmonella in any amount are harmful to pets or humans.

Lystn claims that Congress intended for the AAFCO to “have a seat at the Regulatory Table,” but that the “FDA has instead delegated all mandated regulatory power concerning pet food to AAFCO as though it was the FDA itself.” Lystn further alleges that the FDA and the AAFCO and its member states also worked in concert to sample and debase Lystn’s pet food products, specifically within Colorado.

Colorado’s Department of Agriculture (the Department), a member of AAFCO, pulled Lystn’s products from the shelves of one retail store and tested the food for “adulterants” as defined by AAFCO, which definition was adopted by the Department as its own. AAFCO deems a food adulterated “if it bears or contains any poisonous or deleterious substance which may render it injurious to health.” This definition mirrors the definition found in the Guidance.

The Guidance states that the FDA considers pet food to be “adulterated” “when it is contaminated with any Salmonella and will not subsequently undergo a commercial heat step or other commercial process that will kill the Salmonella.” The Department declared Lystn’s food “adulterated” because of the presence of a non-specified form of salmonella. The Guidance states that it is only a “recommendation.”

Lystn argues that this recommendation is being enforced against it as law – in violation of the separation of powers and the non-delegation doctrine. Its complaint claims the Guidance “is a ‘recommendation’ the FDA – through AAFCO, compels state regulatory agencies to enforce in exchange for a piece of roughly US$11,100,000.00 in FDA funding.” Moreover, Lystn argues that the FDA’s zero-tolerance policy against salmonella is a final agency action since Lystn is facing legal consequences because of it. Lystn therefore characterizes the Guidance as an unlawful “end-run” around the Administrative Procedure Act and formal rulemaking.

Lystn further argues that the definitions of adulteration from the Department and the Guidance “[fly] in the face of the Federal Food, Drug and Cosmetic Act’s [FD&C Act’s] defined terms.” According to Lystn, the mere presence of salmonella does not mean pet food is per se “adulterated” under the FD&C Act.

Lystn contends that the difference between the definitions of “adulterated” in the FD&C Act and the Guidance is that the  definition in the Guidance does not distinguish between alleged “adulterants” that are naturally occurring as opposed to added. Lystn argues that to constrain the Executive Branch’s ability to define the term “adulterated food,” the Legislature, through the FD&C Act, “excluded from the term any food that contains a potentially poisonous or deleterious substance that naturally occurs in the food so long as the quantity of the potentially poisonous or deleterious substance is of such quantity to not ordinarily render it injurious to health.” (Emphasis added.)

Lystn petitioned the District Court of Colorado to enjoin the FDA from enforcing the Guidance in any manner and to declare the Guidance ultra vires.

The case remains in the preliminary stages. There is a pending jurisdictional discovery dispute. We will provide updates on the case as warranted.

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About the Author: Abigail Luhn

Abigail M. Luhn is an associate in the Products Liability and Mass Tort Group in our Florham Park, New Jersey, office. Her practice focuses on the defense of major pharmaceutical and medical device companies in product liability cases involving prescription and over-the-counter medications and medical devices.

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