The U.S. Department of Justice has filed a civil complaint seeking to stop Arrow Reliance Inc., doing business as Darwin’s Natural Pet Products, from manufacturing and distributing pet food until the company complies with federal food safety requirements. Darwin’s leadership disputed the government allegations in a press statement.
The complaint, filed August 7 in the U.S. District Court for the Western District of Washington, names Arrow Reliance and company founder and president Gary T. Tashjian as defendants. The government alleges violations of the Federal Food, Drug and Cosmetic Act involving adulterated animal food, insanitary manufacturing conditions, inadequate preventive controls, failure to register the production facility and marketing claims that allegedly caused the company’s raw pet foods to qualify as unapproved animal drugs.
The allegations have not been proven in court. The case remains at the complaint stage, and no court order stopping production has been issued.
Darwin’s produces approximately 85,000 pounds of frozen raw pet food per week at its Tukwila, Washington, facility, according to the complaint.
Pathogens found in two-thirds of recent FDA samples
Of the 18 most recent Darwin’s raw pet food samples collected by the U.S. Food and Drug Administration since 2023, 12 contained pathogens, the government alleged. Nine contained Salmonella, one contained Listeria monocytogenes, and two contained both organisms.
Third-party testing of unopened products in 2025 also reportedly detected Salmonella in two lots and Shiga toxin-producing Escherichia coli, or STEC, in another.
The complaint cited a 2024 case involving a four-year-old child who developed an E. coli O157:H7 infection, hemolytic uremic syndrome and chronic kidney disease. The family’s dog exclusively ate Darwin’s raw pet food and began vomiting one day before the child became ill. Whole genome sequencing found that E. coli recovered from an unopened package of the dog food was an exact genetic match to the isolate from the child, according to the complaint.
Petfood Industry reported on the case in July 2025. FDA recommended a recall of the affected beef, chicken and duck dog food lots, but Arrow Reliance did not recall them.
From 2016 through January 2026, FDA received 49 consumer complaints reporting illnesses involving 34 dogs and 35 cats that had eaten Darwin’s products, the lawsuit alleged. Five of the dogs and four of the cats were reported to have died. The complaint does not establish that the food caused every reported illness or death.
FDA alleges sanitation and preventive-control failures
During a 2024 inspection, FDA investigators allegedly detected Salmonella inside a hopper used to package finished pet food. The complaint also described:
- Dirty water and equipment debris entering containers of cleanser and sanitizer;
- Pitted or rusted food-contact equipment and deeply cut cutting boards;
- Employees touching unsanitized surfaces and then handling food;
- Condensation falling onto sanitized equipment;
- Aerosolized wash water blowing onto exposed finished food; and
- Water, blood and raw ingredients accumulating in damaged sections of the production floor.
Darwin’s had identified Salmonella, E. coli and Listeria as potential hazards, according to the complaint, but FDA alleged that the company did not implement controls capable of significantly reducing them. The company used peracetic acid, cold storage and other pathogen-control measures, but pathogens allegedly continued to occur in finished products.
The lawsuit also alleged that Tashjian did not register the Tukwila plant as a food facility, despite a 2023 FDA warning that registration was required.
The government further argued that disease-related statements on Darwin’s website caused its raw pet food products to qualify legally as unapproved animal drugs. Those statements associated the food with diabetes, arthritis, seizures, urinary tract infections and IBD.
Regulatory history extends to 2016
Petfood Industry has documented FDA scrutiny of Darwin’s products for nearly a decade.
In 2016 and 2017, Arrow Reliance conducted several recall actions covering Darwin’s and ZooLogics raw pet foods following findings of Salmonella or Listeria. By February 2018, FDA and Washington state officials were investigating a broader pattern of contamination.
A 2017 case involved a kitten that died from a systemic Salmonella infection. Whole genome sequencing found that Salmonella from the kitten’s liver matched bacteria recovered from an unopened package of the Darwin’s food it had eaten. FDA’s April 2018 warning letter also addressed product samples containing Salmonella, Listeria and STEC.
In March 2019, FDA warned consumers about three Darwin’s raw dog food lots containing Salmonella. FDA considered the company’s product-removal actions a recall but said no public notification had been issued and questioned the effectiveness of its customer notices.
FDA issued another advisory in August 2022 after Salmonella was detected in two raw cat food lots associated with diarrhea in three kittens from one household. The federal complaint states that Darwin’s unsuccessfully sued FDA in an attempt to prevent publication of that advisory.
In August 2023, FDA identified Salmonella in three additional dog and cat food lots. Darwin’s did not conduct FDA’s recommended recall. The company responded that the agency’s zero-tolerance policy was primarily intended to protect human health and maintained that its food was safe.
In September 2024, FDA reported that all six sampled Darwin’s lots contained Salmonella, with one also containing Listeria. According to FDA, the company did not conduct the requested recall. Darwin’s disputed the agency’s position and said the affected lots had tested negative using conventional and third-party testing methods.
Most recently, FDA warned consumers in September 2025 about two BioLogics beef dog food lots containing Listeria, one of which also contained Salmonella. Arrow Reliance notified customers about Listeria, but FDA said the notification omitted the Salmonella finding and that the agency could not verify that the products had been removed from customers’ freezers.
Darwin’s disputes government allegations
“We strongly disagree with the FDA’s recent claims and intend to vigorously defend our ability to continue making safe, high-quality raw pet food,” said Tashjian in a statement reported by Feedstuffs. “We have always taken compliance with the FDA’s food safety requirements seriously and have rigorous manufacturing and sourcing standards in place to ensure the quality of our products. In the meantime, we remain squarely focused on our top priorities: supporting the health and wellbeing of the pets we serve.”
The government is asking the court to prohibit Darwin’s from producing or distributing animal food until its facility, methods and controls comply with federal law to FDA’s satisfaction. The requested injunction would also authorize FDA to inspect the company’s facilities and records, with the defendants responsible for the inspection costs.
The case is United States v. Arrow Reliance Inc. and Gary T. Tashjian, No. 2:26-cv-02805.
