A company that markets raw meat and poultry as pet food is suing the FDA saying the agency’s intolerance of Salmonella contamination violates the U.S. Constitution and is a bunch of “gobbledygook.”
Lystn LLC, doing business as Answers Pet Food, filed the federal lawsuit earlier this month in U.S. District Court in Colorado. It names the U.S. Food and Drug Administration, numerous Colorado officials and agencies, and the Association of American Feed Control Officials (AAFCO) as defendants. In keeping with standard public policy, the state and federal agencies do not comment on pending litigation.
In a 34-page complaint, the company refers to FDA policy and safety guidance as “gobbledygook” and makes a vague reference to “punitive inspections.”
The company’s complaint cites the adage “absolute power corrupts absolutely” in its description of the FDA’s zero-tolerance policy for Salmonella in pet foods. The company also contends it’s OK to have “detectable levels” of Salmonella because it is not always harmful to humans or pets.
Answers Pet Food owners contend people should be able to feed their pets such food if they so choose. The company also says an FDA warning about Salmonella in its pet food was libelous. The agency issued the warning after the company refused to issue a recall.
“The FDA’s and participating states’ noncompliance with federal law, while at the same time illegally enforcing the disfavored, nonbinding zero-tolerance guidance deprives the people of the freedom of food choice for their pets,” according to the Answers Pet Food complaint.
“The FDA, AAFCO, and the participating states are arbitrarily and capriciously deciding what pet owners can and should feed their pets while disseminating misinformation harmful to Plaintiff’s Answers Pet Food brand and proprietary processes as though it were scientific fact.”
Guidance from the FDA recommends ways for pet food companies to control pathogens in their products. Companies that do not wish to follow the guidance can opt for other processes if they are reviewed and determined to be equivalent.
Under federal law, the FDA considers a pet food to be adulterated — and therefore unfit for sale — when it is contaminated with any Salmonella “and will not subsequently undergo a commercial heat step or other commercial processes that will kill the Salmonella.”
Officials with Answers Pet Food say they’ve got a system that mostly kills Salmonella.
“. . . instead of using high heat, high pressure, or irradiation — all processes that denature proteins to control bacteria — (Answers Pet Food) uses an alternative approach that satisfies the requirements of the applicable statutes and regulations through fermentation, Hurdle Technology, and other proprietary processes to control bacteria in its product. This includes inoculating the product with Lactic Acid Bacteria (LAB) to a level that potential pathogens such as Salmonella are either eliminated, reduced, and/or have their growth inhibited by this bacterial competition,” according to the complaint.
The complaint also states that the Answers brand food carries a warning label that states:
“WARNING: NOT FOR HUMAN CONSUMPTION. THIS PRODUCT HAS NOT BEEN PASTEURIZED AND MAY CONTAIN HARMFUL BACTERIA.”
The pet food company’s complaint was filed seven months after the FDA’s January public warning about “A+ ANSWERS Straight Beef Formula for Dogs.” The warning was prompted by laboratory findings in Nebraska.
Specifically, the company is asking the federal court to:
- Require all previous claims and references of Plaintiff distributing an adulterated product in which the FDA failed to conduct, follow, and comply with all the requirements, criteria and procedures of the Food, Drug and Cosmetic Act and resulting inspection reports, the Reportable Food Registry listing(s), and any other federal report or record initiated from pursuit of enforcement of the zero-tolerance Compliance Policy Guide be expunged from all federal and state records;
- GRANT Declaratory Judgment that Plaintiff was denied due process rights and FURTHER GRANT an injunction for the FDA and AAFCO’s several participating member states to cease and desist from continued application and enforcement of Compliance Policy Guide Sec. 690.800 Salmonella in Food for Animals , as well as suspend any pending related enforcement actions specific to the application of this Compliance Policy Guide;
- PROHIBIT Defendants from reintroducing similar Compliance Policy Guides that do not strictly follow the Food, Drug and Cosmetic Act or attempt to circumvent the Administrative Procedures Act;
- PROHIBIT Defendants from creating artificial, false, and misleading appearances with respect to raw pet food products, safety, security, commodity, and currency (including removal of such from existing federal government websites and other means of publications); and/or
- Award Plaintiff such other and further relief as this Honorable Court deems necessary and proper.
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