March 26, 2019 - FDA.gov

Fast Facts

• The U.S. Food and Drug Administration is cautioning pet owners not to feed their pets three lots of Darwin’s Natural Pet Products raw dog food after samples from these lots tested positive for Salmonella. The codes for each product are listed in the second group of numbers below the barcode on the package. These products are as follows.
  • Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs: 5309(11)181019, manufactured on October 19, 2018
  • Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs: 5375(11)181106, manufactured on November 6, 2018
  • Darwin’s Natural Pet Products Natural Selections Turkey Recipe with Organic Vegetables for Dogs: 5339(11)181026, manufactured on October 26, 2018
• If you have these lots of Darwin’s Natural Pet Food, throw them away.
• The FDA is issuing this alert because these three lots of Darwin’s Natural Pet Products raw dog food represent a serious threat to human and animal health and are adulterated under the Federal Food, Drug, and Cosmetic Act because they contain Salmonella.
• Salmonella can affect both human and animal health. People with symptoms of Salmonella infection should consult their health care providers. Consult a veterinarian if your pet has symptoms of Salmonella infection.

What is the problem?

The U.S. Food and Drug Administration is cautioning pet owners not to feed their pets three lots of Darwin’s Natural Pet Food because products from these lots tested positive for Salmonella. These products include two lots of Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs (identified in the second group of numbers below the barcode as 5309(11)181019 and 5375(11)181106) and one lot of Darwin’s Natural Pet Products Natural Selections Turkey Recipe with Organic Vegetables for Dogs (5339(11)181026). These products are manufactured by Arrow Reliance Inc., doing business as Darwin’s Natural Pet Products, and are sold online direct to consumers.

The FDA collected and analyzed unopened samples of products from these three lots in response to a consumer complaint. Samples from all three lots tested positive for Salmonella.

Why is the FDA issuing this alert?

The FDA is issuing this alert because these three lots of Darwin’s Natural Pet Products raw dog food represent a serious threat to human and animal health and are adulterated under the Federal Food, Drug, and Cosmetic Act because they contain Salmonella. Because these products are sold and stored frozen, and the FDA is concerned that people may still have them in their possession.

The FDA considers the actions taken by Arrow Reliance to remove violative product from the marketplace to meet the regulatory definition of a recall. However, the firm has not issued public notification, and the FDA is not confident that the firm’s customer notifications are effective for this ongoing recall. The FDA continues to work with Arrow Reliance, doing business as Darwin’s Natural Pet Products, on recalling the remaining products from these lots.

What do I need to do?

If you have Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs (5309(11)181019 and 5375(11)181106) or Darwin’s Natural Pet Products Natural Selections Turkey Recipe with Organic Vegetables for Dogs (5339(11)181026), stop feeding it to your pets and throw it away in a secure container where other animals, including wildlife, cannot access it.

Consumers who have had this product in their homes should clean refrigerators/freezers where the product was stored and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with. Clean up the pet’s feces in yards or parks where people or other animals may become exposed. Consumers should thoroughly wash their hands after handling the recalled product or cleaning up potentially contaminated items and surfaces.

What is Salmonella and what are the symptoms of Salmonella infection?

Salmonella is a bacterium that can cause illness and death in humans and animals, especially those who are very young, very old, or have weak immune systems. According to the Centers for Disease Control and Prevention(CDC), people infected with Salmonella can develop diarrhea, fever and abdominal cramps. Most people recover without treatment, but in some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites unless the person is treated promptly with antibiotics. Consult your health care provider if you have symptoms of Salmonella infection.

Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. If your pet has these symptoms, consult a veterinarian promptly. You should also be aware that infected pets can shed the bacteria in their feces without showing signs of being sick.

Why is the FDA concerned about Salmonella in pet food?

Pet foods contaminated with pathogens such as Salmonella are of particular public health importance because they can affect both human and animal health. Pets can get sick from Salmonella and may also be carriers of the bacteria and pass it onto their human companions without appearing to be ill. The FDA is aware of cases in which humans and/or animals have gotten sick from exposure to contaminated pet foods (Salmonella-human cases, Salmonella-kitten, Salmonella-kitten, dog).

Once Salmonella gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread. Because animals can shed the bacteria when they have bowel movements, it’s particularly important to clean up the animal’s feces in yards or parks where people or other animals may become exposed, in addition to cleaning items in the home.

The Federal Food, Drug, and Cosmetic Act (FFDCA) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. Pet food manufacturers must effectively manage sourcing of ingredients, processing and packing to control pathogens. Without an effective control, such as cooking, raw pet food is more likely than other types of pet food to contain pathogens such as Salmonella. Refrigeration or freezing does not kill the bacteria. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products.

The FDA is the Federal agency that regulates pet food, while the United States Department of Agriculture (USDA) regulates meat and poultry for human consumption. USDA-regulated raw meat and poultry products for human consumption are intended to be cooked and carry instructions to cook the product to a safe temperature. However, raw pet food products are intended to be served without cooking, which creates a potential health hazard for people and pets exposed to these products.

How can I report a pet illness?

People who think their pets have become ill after consuming contaminated pet food should first contact their veterinarians. Veterinarians who wish to have pets tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.

The FDA encourages consumers to report complaints about pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.

Darwin's Response to the FDA -

SEATTLE March 27, 2019 – Today Darwin’s Natural Pet Products disputed an FDA warning regarding pathogens in its raw pet food. The FDA tested three lots of Darwin’s poultry meals, produced in October and November of last year, and claimed to find the presence of Salmonella in them. Darwin’s stated that the warning was inappropriate, as there is no inherent public health risk, and that customers were already aware of the situation as a result of the company’s own communications. Further, the FDA informed Darwin’s that it was issuing the warning because Darwin’s refused to turn over customers’ personal contact information which the FDA demanded to receive.

“We dispute both the recent FDA warning and as well as its policy.” said Gary Tashjian, Darwin’s Natural Pet Products president. “The public warning is inappropriate because we’ve already notified our customers directly via email about this situation on two occasions. More importantly, our customers have told us that this food was consumed by their pets long ago, with no medical issues reported. The facts show that there is no safety risk here.”

Darwin’s sells its meals directly to pet owners, and as a result of that direct relationship with its customers, the company keeps track of customer comments and complaints and can tell quickly if there are problems with its meals by looking for patterns in those calls. Since the product was produced and sent to customers almost four months ago, past experience, supported by customer feedback, indicates that all of this product had already been consumed without any evidence of problems.

Salmonella is inherent in raw poultry products and is unlikely to pose danger to most pets, or to humans when properly handled. Because of this, the USDA, which regulates meat and poultry for human consumption, allows for some presence of Salmonella in raw poultry. All of Darwin’s
ingredients, which are USDA-approved, meet these standards for human consumption. The FDA, however, which regulates pet food, maintains a zero-tolerance policy which disallows any presence of Salmonella, even in quantities too low to cause harm to either humans or pets.

“We find ourselves in the same situation as many other raw pet food companies have found themselves over the past year – having to decide whether to issue a recall for products that we believe are safe for pets, but which do not meet the standards set by the FDA,” said Tashjian. “We believe that the FDA has failed to demonstrate any scientific basis for establishing standards for pet food that are more stringent than the USDA sets for food intended for human consumption. Darwin’s believes that the FDA’s policy is misguided.”

In this instance, the FDA’s test records raised questions as to whether Salmonella was present in the food at all. Moreover, the FDA failed to provide Darwin’s with “split samples” (i.e., retained samples of the tested product) to enable the company to perform its own independent tests to confirm the FDA’s findings – even though the FDA is required by law to do so.

“For all of these reasons, we do not believe that the facts support a recall of these products, which is why we have refused to do so,” said Tashjian. “We also believe that the FDA’s demands for our customers’ personal information infringes on their right to privacy, and is inappropriate under the circumstances.”

Darwin’s encourages its customers and anyone who raw feeds their pet to contact the company for more details about how the company came to this decision. A special toll-free number has been set up for inquiries: 866-832-8319 (Monday-Friday from 6am to 6pm, and Saturday 7am-3pm Pacific Time).

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Previous times Darwin's Pet Food has been in the news -

Voluntary Recalls for Darwin’s Brand Dog Food Due To Contamination Salmonella And Shiga Toxin-Producing Escherichia coli O128

FDA Investigates Pattern of Contamination in Certain Raw Pet Foods Made by Arrow Reliance Inc., Including Darwin’s Natural Pet Products And ZooLogics Pet Food

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