Manufacturer and owner of Darwin’s Natural Pet Products charged with six counts under Federal Food, Drug, and Cosmetic Act
On August 7, 2026, the US Department of Justice (DOJ), acting on behalf of the US Food and Drug Administration, filed a Complaint in federal court against Arrow Reliance Inc. (d/b/a Darwin’s Natural Pet Products) (Darwin’s) and the company’s owner, Gary Tashjian.
The Complaint, which was filed in the United States District Court For The Western District Of Washington At Seattle, seeks to permanently enjoin the defendants from:
- introducing or causing to be introduced, or delivering or causing to be delivered for introduction, into interstate commerce, articles of food that are adulterated;
- by operating a facility that is not in compliance with preventive controls requirements;
- doing acts that result in articles of food becoming adulterated while such food is held for sale after shipment in interstate commerce;
- failing to register as a food facility as required; and
- by introducing or causing to be introduced, or delivering or causing to be delivered for introduction, into interstate commerce, articles of drugs that are adulterated.
The backstory
Darwin’s has been a manufacturer of raw pet food since 2004.
In 2011, the company’s production facility was inspected for the first time by the Washington State Department of Agriculture (WSDA). The sole purpose of the inspection was to determine compliance with rules for handling meat potentially contaminated with the agent that causes ‘mad cow disease.’
In 2014, Darwin’s moved to its present location in Tukwila, Washington. Two years later, the FDA and the WSDA conducted a joint inspection of the company’s manufacturing plant.
During the course of the inspection, the investigators collected two finished product samples for microbiological analysis. One of the samples was found to contain Salmonella. Fortunately, the production lot from which it came had not yet been shipped.
In October 2017, the WSDA received a communication from a consumer who complained that Darwin’s food had made her dog sick. The information was transmitted to the FDA, and a federal inspector collected the remaining food from the consumer’s home. The sample tested positive for both Salmonella and Listeria monocytogenes.
In November 2017, the company sent an email to its customers, advising them of a product recall. One of the customers, whose dog had been suffering from unexplained diarrhea for several months, decided to have her companion tested for Salmonella. When the result came back positive, she filed a complaint with the FDA.
On December 4, 2017, the FDA and WSDA began a joint intensive inspection of Darwin’s. The investigators documented multiple food safety infractions. Two samples collected during the course of the inspection were found to be contaminated with Listeria monocytogenes.
Since the inspection that began in December 2017 and was completed in 2018, the FDA inspected the Darwin’s facility multiple times: in 2018-2019, 2021, 2022, 2023, and 2024. The federal agency and its state partners also found pathogens on multiple occasions, including Salmonella, Listeria monocytogenes, and E. coli O128 (shiga toxin-producing E. coli, or STEC).
Sick pets
The FDA has received reports in past years of sick animals who had been fed a Darwin’s product.
In December 2018, after receiving a report of Salmonella infection in a sick dog, the agency collected unopened packages from three different lots of Darwin’s dog food from the pet owner’s home. They found Salmonella in all three samples.
In July 2022, the FDA was contacted by a cat owner whose three cats became sick after being fed Darwin’s raw cat food. Again, the agency collected unopened packages of three different lot codes from the cat owner’s home. Two of the three samples were found to contain Salmonella.
In September 2023, four cats in the same household became sick after eating a Darwin’s cat food. A sample of unopened food collected from the cat owner’s home was positive for Salmonella.
In August 2025, the FDA received a complaint of a dog death. Unopened packages collected from the pet owner’s home were found to contain Listeria monocytogenes in one instance and both Salmonella and Listeria monocytogenes in the other instance.
Overall, from 2016 through January 2026, the FDA received a total of 49 consumer complaints involving sick pets who had been fed a Darwin’s raw pet food. The list includes 34 sick dogs, including five that died, and 35 sick cats, including four deaths.
Sick people
In June 2025, the FDA was informed of a four-year-old child who had become infected with E. coli O157:H7 the previous year and had developed hemolytic uremic syndrome (HUS). The child’s family fed its pet dog Darwin’s raw pet food. Third-party tests conducted on unopened Darwin’s food from the family’s home found Salmonella, and a sample from a different lot was contaminated with E. coli O157:H7.
The genetic profile of the E. coli O157:H7 isolated from the child’s stool was an exact match to the isolate recovered from the unopened Darwin’s pet food sample collected from the family’s home.
As part of its investigation, the FDA compared the genetic profile of isolates from Darwin’s pet foods against the profiles of clinical and food surveillance isolates in the public database maintained by the National Center for Biotechnology Information. Nine of the isolates from Darwin’s pet food samples collected in 2017, 2018, 2022, 2024, and 2025 matched human clinical isolates in the database.
Company push-back
On multiple occasions, Darwin’s has refused to initiate product recalls after the FDA or one of its partner state agencies documented the presence of a pathogen such as Salmonella, Listeria monocytogenes, or STEC in a sample of its pet food. In these cases, the FDA has resorted to public health notices instead.
On August 2, 2022, the company filed a Motion for a Temporary Restraining Order and Preliminary Injunction in federal court, asking that the FDA be prevented from posting a notice to alert the public to the presence of a pathogen in a Darwin’s product.
The Court rejected the motion and the FDA was able to post its public health notice three days later.
Darwin’s has repeatedly denied that its products were adulterated, claiming, among other arguments, that the presence of Salmonella in raw meat or poultry is natural, and is allowed by the USDA.
In April 2018, the FDA issued a Warning Letter to the company, advising that its products were adulterated under the Federal Food, Drug, and Cosmetic Act. The Warning Letter noted the presence of Salmonella and STEC in samples of the company’s products.
The agency issued a second Warning Letter in February 2023, noting that the company’s pet food was contaminated with Salmonella.
Neither Warning Letter had the desired effect.
The charges (and brief explanations)
Adulteration due to containing a poisonous or deleterious substance.
Food is adulterated if it bears or contains a poisonous or deleterious substance, such as Salmonella or STEC.
Adulteration due to production under insanitary conditions
Darwin’s manufactured, packed, and held ready-to-eat raw pet food without eliminating Salmonella, STEC and/or Listeria monocytogenes from the finished food as part of the manufacturing process.
The FDA recovered Salmonella from an environmental swab sample during their 2024 inspection of the company’s manufacturing facility. The inspection team also noted dirty water and debris from dirty equipment pooling on top of containers of cleanser and sanitizer and falling into the opening of those containers. Also, the floor throughout the production room and the base of a pillar were damaged and pitted, with water, blood, and raw ingredients accumulating in the damaged areas.
Failure to follow preventive controls regulation
The company identified contamination of their pet food with Salmonella, E. coli, and Listeria monocytogenes as possible hazards, but failed to identify adequate preventive controls to minimize or prevent the hazards from occurring.
FDA made the company aware of the repeated presence of pathogens in their raw pet food products, but Darwin’s has not remedied their conduct.
Failure to register as a food facility
Darwin’s meets the definition of a food facility, which is an “establishment, structure, or structures under one ownership at one general physical location…that manufactures/processes, packs, or holds food for consumption in the United States.“
Despite the notification contained in the FDA’s February 16, 2023, Warning Letter, the company’s owner, Gary Tashjian has failed to register Darwin’s facility.
Introduction of unapproved New Animal Drug into interstate commerce
Statements on the company’s website include claims that Darwin’s raw pet food is intended to prevent, cure, and/or treat disease in animals. The company’s claims qualify the raw pet food products as drugs “…intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.”
Ongoing conduct
Based on the experience and evidence accumulated over a period of almost ten years, the FDA believes that the company will continue to violate the Federal Food, Drug, and Cosmetics Act and regulations unless restrained by the Court.
The bottom line
The DOJ, acting on behalf of the FDA has asked the court to:
- Order the company, Gary Tashjian, and any and all persons in active concert or participation with them to “…cease manufacturing, processing, preparing, packing, holding, or distributing articles of animal food, unless and until Defendants’ facilities, methods, processes, and controls used to manufacture, process, prepare, pack, hold, and distribute articles of animal food are established, operated, and administered in conformity with the FDCA and applicable regulations, in a manner acceptable to FDA.”
- Permanently restrain and enjoin the company, Gary Tashjian, and any and all persons in active concert or participation with them from directly or indirectly
- introducing or or delivering into interstate commerce any adulterated animal food
- operating a food facility without complying with preventive controls
- causing animal food held for sale after shipment to become adulterated
- operating a food facility without registering
- introducing or delivering into interstate commerce any adulterated new animal drug
- Authorize the FDA to inspect Darwin’s place of business and all records relating to the manufacture, processing, preparing, packing, holding, and distribution of the company’s products to ensure continuing compliance with the terms of the injunction, with the company bearing the costs of such inspections.
- Award costs to Plaintiff (FDA) incurred to date, including the costs of the investigation to date.
“A complete and compelling account of the hidden and not-so-hidden ways the food we give our beloved pets can be contaminated.” – JoNel Aleccia, Health Reporter, Food & Nutrition, The Associated Press.
“An invaluable resource for busy pet owners” – Food Safety News
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