Information Regarding Regulatory Notice

July 29th, 2025

Today, the Food and Drug Administration (FDA) released a notice regarding three samples of our product. We’re writing both to inform you of this notice and to clarify what we believe to be misrepresentations made in the FDA’s communication.

Last month, we received communication from a third-party laboratory of testing they were performing on samples of our product manufactured and distributed to customers over a year ago, due to a report that in August of 2024, a child had become ill. An illness report has never been made directly to us, nor have we had any other reports of illness regarding the lots impacted. 

Of the 20 samples tested, they reported one single package tested positive for the presence of E. Coli and two individual packages tested positive for the presence of salmonella. 

This testing has not been validated. We have not been able to replicate these results with our own retained samples of this lot, and all of our raw materials have tested negative for pathogens. 

That said, per our protocol, we immediately notified the FDA of this testing report.  

As these samples were retained by the third-party after almost a year, we have no way to verify how they were handled prior to or during testing. Additionally, the FDA has not tested these samples nor any samples from these lots to confirm this third-party’s findings.

Yesterday, we were asked by the FDA to issue a recall regarding these lots. In response, we requested additional data and testing from the FDA. They refused this request.

We have been in constant, proactive communication with the FDA in an effort to investigate this report. Given these active conversations, we were both bewildered and disappointed in the FDA’s statement. We believe their notice to be inappropriate and premature, given the lack of information available to both us and the FDA regarding this report.

Inasmuch as we have not been able to validate the results from this third-party, as we believe all of the food from these lots has already been consumed in 2024, as there have been no other illness reports regarding these lots, and as the FDA themselves has not tested these samples nor confirmed the validity of the testing performed, we do not believe these lots pose a risk to our customers. 

We understand communications like this from the FDA can be concerning. Your pet’s safety is our top priority, and we want to assure you that we have the utmost confidence in the safety of our meals. Through our strict sourcing standards, rigorous safety practices, and testing, we can ensure our meals are safe for your pets and ours.

We also want to remind customers to follow simple hygiene practices consistent with how you should always handle raw meat. This includes always washing contact surfaces, dishes, and utensils used to serve raw meat. 

 

Q) What lots were impacted?

A) 

  • Lot # 10662    BLD-BF02    Produced 5/30/24    Last Distributed 7/7/2024

  • Lot # 10638    NSD-DK02    Produced 5/22/24    Last Distributed 7/9/2024

  • Lot # 10683    BLD-CH02    Produced 6/5/24    Last Distributed 7/14/2024


Q) Have there been any illness reports?

A) Last month, a third-party lab contacted us regarding a report made to them of a child becoming ill in August, 2024. We have received no other reports of illness regarding these lots.

Q) Are these lots still in distribution?

A) No. All of these lots were distributed over a year ago, and we believe all of the meals from these lots were already consumed by pets in 2024.

Q) What testing has been done?

A) A lab conducted testing on samples it retained that are over a year old. In total, 20 samples were tested. One sample of Lot # 10662 tested positive for E. Coli. Individual samples of Lots # 10638 and # 10683 tested positive for Salmonella.

It is important to note we have not been able to validate this testing or the handling of the samples retained, nor has the FDA. Additionally, we’ve conducted testing on our raw ingredients and found them all to test negative for all pathogens.

Q) How do you know that your raw pet food is safe?

A) Nothing matters more to us than the health of the pets that eat our food. To ensure their safety, we use a multi-step process to prevent or eliminate pathogens while maintaining nutritional integrity. That process is as follows:

  • First, we source our ingredients from some of the best farms and ranges in the industry. Our livestock and poultry are raised under healthy, humane conditions, making it less likely they will harbor pathogenic bacteria.

  • We require our meat and vegetable suppliers to apply an antimicrobial wash to everything they send to us.

  • We employ a pathogen control process at our facility that involves using organic acid to naturally eliminate any unwanted pathogens.

  • We provide our customers with detailed instructions on how to safely store and serve our food to keep themselves, their families, and their pets safe.

Q) Why do you continue to have FDA warnings?

A) This is a regulatory, bureaucratic issue, not a pet safety issue. The FDA’s primary concern is for human health and it sets standards accordingly. Unfortunately, that means FDA standards do not account for the fact that dogs and cats have different health needs than humans; raw food helps pets maintain the good bacteria that are crucial to their gut health and immune system.

Q) So why is the FDA so concerned with pet food?

A) The FDA’s opposition to raw pet food is longstanding and well known but it is not supported by scientific fact. The FDA’s focused on reducing potential contamination risks for the humans handling raw pet food. The concerns are easily addressed through basic hygiene in a very similar fashion to handling raw foods such as chicken, for example. This includes routine handwashing and thorough cleaning of surfaces and cooking utensils.

Q) Why are you confident that your raw pet food is safe when some veterinarians recommend against raw pet food?

A) Our work shows – and our customers know -- the long-term health benefits of a raw pet food diet and that these benefits far outweigh any low and preventable risks. We have seen the significant health benefits of a raw diet both firsthand for our own pets and for thousands of our customers’ pets. We remain committed to providing safe, healthy, nutritious meals for pets.

Q) Why don’t you sterilize your food to meet the FDA’s standards?

A) The FDA’s standards are based on the consumption of raw food for humans, not pets. Sterilizing our food would remove the nutritional benefits of a raw food diet. Cooking and high-pressure processing destroys most of the vital enzymes and vitamins in the ingredients. It’s important to maintain the nutrients that are responsible for many of the dramatic changes that our customers tell us they see in their pets after feeding them our food such as: relief from common skin problems; a sharp decrease in common diseases and conditions like arthritis and diabetes; and improved digestion.

Q) Why aren’t you worried about bacteria?

A) These bacteria typically are not harmful to pets and have only been found in trace amounts in a very small proportion of our pet food. These trace amounts do not pose a risk to pets unless they have serious underlying conditions, in large part because pets have much shorter digestive tracts than humans. The food samples are still flagged by the FDA under its zero-tolerance policy, which is largely designed for human safety and for food that humans will consume, not pets.

Real Raw, made for your pet

Only the best quality real meat, portioned for your dog or cat. Delivered frozen.

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20+ years pioneering raw

20+ years pioneering raw

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Families fed to Millions of meals serve

Trusted by pet parents nationwide

Vet Access

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Vet support during transition

Real Benefits, Visible Results

When you feel better, they live better

Better Digestion

Smaller, firmer stools and easier digestion with food your pet's body can actually use.

Shinier Coat

Real protein and natural fats support skin and coat health from the inside out.

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Every meal plan is calibrated to your pet's age, weight, breed, and activity.

Mealtime Excitement

The first bowl is usually gone before you set the second one down.

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Nothing to decode on the label

Real meat, real organs, real veggies. Every ingredient is one you can name without Googling.

No fillers No artificial preservatives No mystery ingredients No by-products No grains or corn

How It Works

Fresh feeding, made simple.

Shinier Coat

01

Tell us about your pet

Shinier Coat

Age, weight, breed, allergies — we use it all to build a plan made for them.

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02

Check your doorstep

Frozen meals, delivered

Insulated, recyclable packaging.

Bowl-ready in minutes

03

Watch them thrive

Bowl-ready in minutes

Thaw, peel, serve — and see the change start in week one.

The difference is is in the bowl

Real, recognizable ingredients
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No mystery fillers
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Turkey
Turkey
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Beef
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Rabbit
Poultry Blend
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Duck

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Pet parents share what changed when they switched their dogs and cats to Darwin's fresh raw food.

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Allergies & Skin

Chronic skin problems — completely resolved

"Our cats were struggling with constant fleas and skin conditions after we moved near farm animals. Nothing the vet prescribed worked until we switched. Darwin's was a complete transformation."

A Worry-Free Switch

The Transition Plan

Moving to raw can feel daunting, but it shouldn't be. Our transition guide takes your pet from kibble to raw in 10 days, and our on-staff vet experts are just a call away to support you.

Days 1-3
25% Darwin's + 75% Kibble
Start with a teaspoon.
You may notice:
  • Excitement at mealtime
  • Slight stool changes
Days 4-6
50% Darwin's + 50% current food
Don't rush it. Let your pet adjust to the new food.
You may notice:
  • Smaller, firmer stools
  • Improved appetite
Days 7-9
75% Darwin's + 25% current food
Your pet is mostly adjusted to the new diet.
You may notice:
  • More energy
  • Early coat improvements
Day 10
100% Darwin's
Your pet is fully transitioned.
You may notice:
  • Consistent digestion
  • Better breath
  • Healthier coat and energy

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