DOJ Seeks to Halt Darwin’s Natural Pet Products Over Years of Pathogen Contamination

DOJ Files Injunction Against Darwin’s Natural Pet Products Over Contaminated Food

The U.S. Department of Justice, on behalf of the FDA, has asked a federal court to permanently block Washington state-based Arrow Reliance Inc., which does business as Darwin’s Natural Pet Products, from manufacturing and selling any more pet food. The complaint, filed on August 7 in the Western District of Washington, alleges that the company and its owner Gary T. Tashjian repeatedly violated the Federal Food, Drug, and Cosmetic Act by failing to follow mandatory preventive controls, allowing uncooked pet food to become contaminated with dangerous bacteria.

Inspections from 2017 through 2025 found Salmonella, Listeria monocytogenes, and Shiga toxin-producing E. coli (STEC) in finished product samples, including unopened bags. In 2024, FDA investigators also detected Salmonella inside the company’s Tukwila facility. According to the government, multiple consumers have reported illnesses in pets and humans linked to the products, and at least one four-year-old child developed hemolytic uremic syndrome—a severe kidney condition—after the family dog was fed Darwin’s food. Testing of that unopened pet food confirmed both Salmonella and STEC.

The civil suit seeks an injunction that would require Tashjian and Arrow Reliance to implement sanitation upgrades and fully comply with preventive controls regulations before any future production or distribution. The government emphasizes that the life-threatening risks extend beyond pets to vulnerable household members—pregnant women, the elderly, and the immunocompromised—who can suffer miscarriages, stillbirths, or death from these bacteria.

Inside the Arrow Reliance Enforcement: Salmonella, Listeria, and a Child’s Illness

A Pattern of Warnings and Contamination

Arrow Reliance has been on the FDA’s radar for nearly a decade. The complaint indicates that between 2017 and 2025, agency testing of finished products repeatedly returned positive results for pathogenic bacteria, and the firm’s own facility showed Salmonella in 2024. Despite warnings and an opportunity to voluntarily correct the conditions, the company allegedly continued to ship products that pose a direct health risk. This long timeline is critical because it shifts the narrative from isolated incident to systemic failure, making a permanent injunction more likely to be granted.

The 2024 Child STEC Infection as a Turning Point

While pet illnesses are common in such cases, the 2024 infection of a four-year-old with hemolytic uremic syndrome—confirmed by independent lab analysis of the family’s unopened Darwin’s food—escalates the matter into a public health crisis. The complaint explicitly ties human illness directly to the pet food, a connection that is often difficult to prove. This strengthens the DOJ’s argument that the company’s failure to control hazards endangers not just animals but children and other vulnerable people in the household, raising the stakes for any potential settlement or trial defense.

Regulatory Escalation and the FDCA Preventive Controls Framework

The case is not based on a single contaminated batch but on an alleged failure to implement the preventive controls required under the FDCA’s current good manufacturing practice rules for animal food. Arrow Reliance’s raw pet food model—uncooked products that rely on high-pressure processing or similar steps—may be inherently harder to validate, but the complaint signals that the FDA and DOJ are unwilling to accept repeated contamination as an unavoidable byproduct. The government’s legal team includes both DOJ civil enforcement litigators and an FDA associate chief counsel, indicating a coordinated push that could set a precedent for how other raw-pet-food makers must operate.

What Pet Owners and Manufacturers Should Do Now

For pet owners: Treat raw pet food as a potential biohazard. The confirmed presence of pathogens in unopened bags means contamination can occur before you open the package. Always wash hands and surfaces after handling, and keep feeding bowls separate from human food preparation areas. If you have young children, pregnant women, or immunocompromised family members, consider cooking the food or switching to a commercially sterile alternative.

For pet food manufacturers: This case underscores that documented, validated kill steps (or equivalent pathogen controls) are not optional. The FDCA preventive controls rule requires a written food safety plan that addresses known hazards like Salmonella and Listeria. A failure to produce such evidence—especially after years of warning letters and positive pathogen tests—will likely draw injunction action.

For retailers and veterinarians: Given the FDA’s findings, you may want to proactively advise customers on safe handling of raw diets. The detection of pathogens in unopened finished product highlights that the risk is not eliminated by consumer storage alone and that staff should be trained to communicate this.