Darwin's Natural Pet Foods Responds to the 2026 FDA Legal Action

 

Darwin’s believes the FDA’s actions represent regulatory overreach and don’t align with the science of pet safety and nutrition

On August 7, 2026, the U.S. Food and Drug Administration (FDA) filed a complaint in the U.S. District Court for the Western District of Washington, asking a federal court to limit Darwin’s ability to make and distribute its raw pet food. Darwin’s disagrees with the FDA's allegations, and it has filed a legal response that sets forth the company’s position on behalf of the thousands of pet families that rely on Darwin’s.

Darwin's pet food is not being recalled, and the company is not being shut down. Darwin’s meals remain available at darwinspet.com, and the company is confident its meals are safe.

A message from Gary Tashjian, CEO of Darwin's

To the Darwin's community:

When I founded this company over 20 years ago, my goal was simple: to provide pets with fresh, nutritious food that helps them live long, healthy lives. That mission remains unchanged.

At Darwin’s, we’re committed to the safety of the pets we feed and the people who love them, which is why I’d like to address the FDA's legal action against us.

At the core of our dispute is the FDA's zero-tolerance policy for salmonella in raw pet food. The FDA seeks to impose an arbitrary standard, which has no basis in either science or law, that would require raw pet food makers to eliminate all traces of salmonella, even strains not known to be harmful to either pets or humans. The USDA does not apply that standard to the same raw meat sold for human consumption, which is the meat we use. Anyone handling raw meat faces the same exposure, whether they're cooking for their family or feeding their pet. That's why we believe the two standards don't make sense.

As we state in our court filing, we believe the FDA is engaging in regulatory overreach. That overreach creates a double standard that harms Darwin's and other raw pet food manufacturers, and ultimately pets and pet owners. We also believe the FDA’s actions are unlawful and inconsistent with the science of pet safety and nutrition.

We do not dispute the FDA’s findings made during its previous inspections of our facilities, and we always welcome recommendations that help us improve. We dispute the conclusions the FDA draws from them. We believe our current food safety practices meet regulatory requirements and have been demonstrated to be effective through third-party review.

We would prefer to focus our resources on serving pets, not fending off the federal government. We have expressed a desire to negotiate with the FDA for years, but the agency has shown little interest in an outcome that would allow our business to continue operating.

While the FDA performs a valuable function for the American public, we believe it has inconsistently and inappropriately applied the law against small pet food manufacturers like us. For this reason, we look forward to presenting our case in court.

In the meantime, nothing changes about how we make your pet's food. We remain singularly focused on providing high-quality, nutritious food that lets pet owners enjoy more years of healthy companionship, and we will keep communicating with you openly throughout this process.

Thank you for your trust.

Gary Tashjian, CEO, Darwin's Natural Pet Products

What happened: a timeline of the Darwin's FDA lawsuit

The FDA's complaint draws on sanitation and product quality allegations from the past several years.

When	What happened
2018 onward	The FDA issued advisories about certain Darwin's lots, most citing trace amounts of salmonella, including those that are not known to be harmful to either pets or humans. As a direct-to-consumer company, Darwin’s is in constant communication with its customers and hears about any issues right away. There have never been reports of illness outbreaks tied to any of these meals.
2022	Darwin's challenged the FDA's zero-tolerance salmonella policy for raw pet food. The agency countered with procedural arguments.
2024	In the course of its most recent inspection of Darwin’s facility, FDA took more than 100 swabs around the Darwin’s production facility.  As evidence of the effectiveness of Darwin’s sanitation programs, all but one of those swabs tested negative for any pathogens. The single swab that tested positive for salmonella was taken from a piece of equipment that had just processed USDA-inspected raw poultry, in which salmonella occurs naturally, and is permitted by USDA standards.
June 2026	Darwin’s commissioned an outside food safety consultant to review the company’s food safety programs. The consultant found Darwin’s Food Safety Plan and related documents consistent with the requirements of the FDA's current good manufacturing practice, hazard analysis, and risk-based preventive controls regulations for animal food.
August 7, 2026	The FDA filed a complaint asking the court to limit Darwin's ability to make and distribute the company’s raw pet food.
September 16, 2026	Darwin's filed its legal response, challenging the FDA's efforts to circumvent Federal law by imposing a zero-tolerance salmonella standard on raw pet food manufacturers As stated in Darwin’s filing, “… the agency has continued to target Darwin’s relentlessly, creating public misperceptions about the company’s safety record and refusing to acknowledge Darwin’s demonstrated commitment to pet health and transparent communications with customers. Although the FDA is apparently trying to shut down Darwin’s business, leaving its 50 employees looking for work and preventing thousands of customers from accessing the high-quality raw pet food they rely on, Darwin’s stands by the safety of its products and welcomes the opportunity to finally have this Court examine FDA’s conduct and misguided legal interpretations.”
As of October 13, 2026	Darwin's continues to make and ship high-quality, nutritious meals to thousands of pets nationwide. No recall has been issued, and the case is ongoing.

 

What Darwin’s has done to address the FDA’s concerns

Darwin’s has filed a legal response to the FDA’s complaint, commissioned an independent review of its safety programs, and maintained steady production and customer communication.

• Independent food safety review: In June 2026, an outside consultant reviewed Darwin’s Environmental Monitoring Program, Food Safety Plan, Good Manufacturing Practices, PAA Program, Sanitation Program, and Supply Chain Program. The consultant found the company’s Food Safety Plan and related documents to be consistent with the requirements of the FDA's current good manufacturing practice, hazard analysis, and risk-based preventive controls regulations for animal food.
• Darwin’s legal response: Together with its legal counsel, Darwin’s filed a response to the FDA's complaint. Darwin’s is using this case to challenge the FDA's zero-tolerance salmonella policy and its reliance on supposedly non-binding guidance documents to impose that standard on manufacturers. The company states in its filing, “Darwin’s stands by the safety of its products and welcomes the opportunity to finally have this Court examine FDA’s conduct and misguided legal interpretations.”
• Acting on inspection observations: Past FDA observations have been relatively minor. Many issues were corrected before the inspector left the room, and in every other case, Darwin’s changed its processes to address them.
• Maintaining Darwin’s safety program: Darwin’s continues to operate under a formal Hazard Analysis and Critical Control Points (HACCP) plan, and the company’s Food Safety Plan has been in place for more than five years with routine review. See our safety standards.
• Staying close to customers: As a direct-to-consumer company, Darwin’s is in constant communication with its customers and hears about any issues right away. Darwin’s links each complaint to the lot it came from, which lets the company spot trends or patterns across households. If feedback about a specific food lot reaches a critical threshold, such as pets becoming ill or product not meeting Darwin’s specifications, the company stops distributing the product and contacts customers directly. If an internal review finds the lot was compromised, the company destroys all affected inventory and informs its customers. 
• Continuing to improve: Constant improvement is part of Darwin’s DNA, and the company continues to evaluate additional pathogen control methods that could further reduce harmful bacteria while preserving the nutritional value of the ingredients. Read how Darwin’s approaches raw pet food safety.

Frequently asked questions about Darwin's and the FDA

Is Darwin's pet food being recalled?

No. Darwin’s pet food has not been recalled. The company continues to provide safe, healthy meals to thousands of pet owners across the country.

When there is a food safety concern, which is rare, Darwin’s contacts affected customers directly and offers to replace the food at no charge. Because Darwin’s sells directly to its customers, this serves the same function as a recall.

Is Darwin's pet food safe?

Yes. Darwin's is confident its meals are safe. The company’s sourcing and manufacturing protocols protect product quality while preserving the beneficial bacteria important to pets' gut and immune health.

In June 2026, an independent food safety consultant found Darwin’s Food Safety Plan and related documents were consistent with the requirements of the FDA’s animal food safety regulations. Read our safety standards.

Why is the FDA taking legal action against Darwin's?

On August 7, 2026, the FDA filed a complaint asking a court to limit Darwin's ability to make and distribute its raw pet food. The complaint raised sanitation and product quality allegations from the past several years.

Darwin’s takes the FDA’s conclusions seriously and has addressed elements of the agency’s complaint operationally, but it disputes the agency’s conclusions. The company believes the central issue is regulatory overreach, not food safety.

For roughly two decades, Darwin’s has navigated an FDA regulatory environment that was designed for human food, not pet food, and this has been a steady source of friction with the agency.

What is the FDA's zero-tolerance salmonella policy, and why does Darwin's disagree?

The FDA's policy would require raw pet food to contain no salmonella of any kind, including strains not known to harm either pets or people. The policy stems mainly from concerns about the health of people handling the food. Yet the USDA does not apply that standard to the same raw meat sold for human consumption, which is the meat Darwin’s uses.

The veterinarians whom Darwin’s has consulted generally agree that dogs and cats are not susceptible to many salmonella strains and that salmonellosis in pets is rare. Even the FDA acknowledges that salmonellosis is uncommon in dogs and cats.

Darwin’s also objects to how the policy is applied:

• The FDA's testing incubates samples before testing, multiplying bacteria so they can be detected. A sample can test positive even when the original amount was too small to detect, let alone harm a pet.
• There are more than 2,500 strains of salmonella. Only a few are known to harm humans, and fewer still are  known to harm pets.
• In the case of salmonella, the law requires the FDA to determine whether a strain is pathogenic, and whether it is present in an amount "ordinarily injurious" to dogs or cats, before deeming a product adulterated. In Darwin’s experience, the FDA has ignored this legal requirement and failed to conduct such required testing.

Has there been a recent increase in health issues with Darwin's food?

No. The FDA's complaint references historic incidents that Darwin’s has already addressed and communicated to affected customers at the time.

Most complaints Darwin’s receives from customers concern packaging or delivery. Of the few related to a pet's response to the company’s meals, most involve a pet not eating the food or having a temporary reaction to the meals, rather than becoming sick.

What about the FDA's claims that pets became ill?

Darwin’s believes the evidence does not support the FDA's conclusion that the company’s food caused the illnesses it cites. Every instance that the FDA cites was isolated, typically a single pet or household out of the hundreds who received and consumed food from each lot. Darwin’s has no reported cases of multiple pets from different households becoming seriously ill after eating food from the same production lot.

Where a pet has become ill after a Darwin's meal, most cases involve temporary reactions such as regurgitation or loose stools; few require veterinary care. The company does not dispute these families' experiences and takes every concern seriously, but many cases lack a definitive diagnosis linking the illness to Darwin’s meals.

Why has the FDA issued advisories about Darwin's pet food?

Most FDA advisories about Darwin's relate to trace amounts of salmonella found without any evidence of potential harm. There have never been reports of illness outbreaks associated with the meals named in those advisories.

The occasional reports the company has received about those meals were typically isolated cases, such as a pet refusing a meal, regurgitating, or having loose stools, that resolved quickly. Reports of pets needing veterinary care are extremely rare.

Why does Darwin's notify its customers directly instead of issuing public recalls?

The recall and public notice process is designed for brands sold through retail stores, which can't identify who bought a particular product. As a direct-to-consumer company, Darwin’s can trace exactly which households received food from each lot. So on the rare occasions the company has identified a potential health concern, it has contacted those customers directly and promptly. This approach has served Darwin’s customers well, and it's why the company doesn’t issue public recalls.

What did the FDA find at Darwin's Tukwila facility?

The FDA last inspected Darwin’s Tukwila facility in 2024, and its observations were relatively minor.

The complaint cites a 2024 swab that tested positive for salmonella. That swab was taken during a poultry production run, on a surface in contact with USDA-inspected poultry, which is permitted to carry low levels of salmonella. It was the only swab, out of more than 100 taken during that inspection, to test positive for any pathogen.

Is Darwin's being shut down?

No. Darwin's continues to provide safe, healthy meals to thousands of pet owners, and the company is prepared to defend against any claims that question the underlying safety of its food.

Are Darwin's products still being sold?

Yes. Darwin's meals are available for purchase online at darwinspet.com.

If I bought Darwin's before the FDA complaint, is it still safe to feed?

Yes. Darwin’s is confident its meals are, and always have been, safe for pets to eat. Keep the food frozen, follow the company’s hygiene guidelines, and sanitize everything used in preparation.

Should I cook Darwin's food?

No. If you have been feeding Darwin's raw food, you should feel safe continuing to do so. Darwin’s sources all proteins from facilities that meet or exceed USDA standards.

As with any raw meat, wash your hands, food preparation surfaces, and your pet's bowl after each meal—the same standard you'd use when preparing raw meat for yourself.

How does Darwin's balance nutrition and safety?

Darwin’s believes minimal processing of high-quality ingredients is the best way to feed pets. Over the years, the company has explored many approaches and safety precautions, and Darwin’s is confident its current practices strike the right balance between safety and nutritional value. Learn how quality starts at the farms we source from.

What safety and quality practices does Darwin's follow?

Darwin’s core safety practices include:

• Employees trained in strict good manufacturing practices (GMPs), including sanitation, hygiene, quality management, documentation, and recordkeeping.
• All proteins sourced from facilities that meet or exceed USDA standards, backed by a strict vendor approval program.
• An antimicrobial treatment applied to all products before production to reduce pathogens while preserving beneficial bacteria.
• Meat ingredients that arrive frozen and are held at 32°F or below.
• Packaged meals deep-frozen to -10°F until they are ready to ship.
• Equipment cleaned and swab tested before production and between every lot.

How does Darwin's track customer complaints?

Darwin’s uses an internal point system to trace every customer complaint to the lot it came from. If feedback reaches a critical threshold, such as multiple animals becoming ill or a product not meeting the company’s specifications, Darwin’s stops distributing that product and contacts customers directly. If an internal review finds a lot was compromised, the company destroys all affected inventory and informs its customers.

Is Darwin's willing to settle with the FDA?

Darwin’s has expressed a desire to negotiate with the FDA for years, but the agency has shown little interest in a resolution that would let the business keep operating. Darwin’s would prefer to avoid costly litigation, but it appears it will need to rely on the courts.

What happens next?

Darwin’s is responding to the FDA's complaint with its legal counsel while continuing to make high-quality raw pet food. The case is ongoing, and this page will be updated as it develops.

Learn more about Darwin's safety standards

Want to see exactly how Darwin’s keeps your pet's meals safe? Start here:

• Safety Standards: How Darwin’s sources, tests and prepares every meal, from farm HACCP plans to lot-by-lot equipment swabs.
• Raw Pet Food Safety Standards: What safe raw feeding looks like and how Darwin's meets that bar.
• Quality Starts at the Farms: The farms and suppliers behind Darwin’s human-grade, USDA-inspected ingredients.
• Meet Dr. Tori: The veterinary expertise behind Darwin’s meals.
• Meet Darwin’s Advisors: The experts who guide Darwin’s nutrition and safety practices.

Last updated October 13, 2026. This page will be updated as the case develops.