Raw pet food company sues to block FDA public health alert

Arrow Reliance Inc. (d.b.a. Darwin’s Natural Pet Products) has filed suit in US federal court in an attempt to prevent the US Food and Drug Administration (FDA) from issuing a Public Health Alert about possible Salmonella contamination in a cat food product.

Darwin’s, which is based in Tukwila, Washington, filed the their request for a temporary restraining order on July 29, 2022, in the US District Court, Western District of Washington (Case 2:22-cv-01057).

Screen Shot 2022-08-01 at 1.58.32 PMThe lawsuit contends that the FDA “wrongfully” threatened to issue the Public Health Alert if the company refused to issue a recall of its adult cat food.

The FDA’s request for a product recall apparently arose after kittens tested positive for Salmonella.

When contacted by eFoodAlert, a spokesperson for the FDA stated that the agency does not comment on pending litigation.

The background

logo-Darwins-pet-foodDarwin’s is the producer and distributor of a range of raw food products for dogs and cats.

The company was founded in 2002 by Gary Tashjian, who began producing frozen raw pet foods in his own kitchen.

In time, Tashjian moved his manufacturing operations into a facility in Tukwila, WA, just outside of Seattle.

In June 2016, the FDA received a consumer complaint about foreign objects in the company’s products. In response, the FDA and representatives from the Washington State Department of Agriculture (WSDA) paid a visit to the Tukwila facility.

During the course of their visit, the FDA and state investigators noted several objectionable conditions in the production plant. They also reviewed the company’s consumer complaint log, including four complaints that mentioned Salmonella.

As part of their follow-up, WSDA inspectors sampled two of the finished raw pet food products for lab analysis. One of those samples was found to contained Salmonella.

In response, the company destroyed its inventory of the contaminated production lot. As none of the product had been shipped, there was no need for a recall.

In December 2017, following a spate of product recalls due variously to Listeria monocytogenes, Salmonella, and/or E. coli O28 in multiple product samples, the FDA returned to Darwin’s plant to conduct an intensive investigation that lasted until late January 2018.

During the course of its investigation, the FDA became aware of at least six customer complaints about sick pets, including one dead kitten.

On April 2, 2018, the FDA issued a formal Warning Letter, notifying the company of its findings and giving the company fifteen business days in which to respond with a written description of corrective actions.

The company was reinspected in 2018/19, during which time Darwin’s management refused to supply the FDA investigation team with records pertaining to the production, sanitation, environmental testing and distribution of finished product lots using the same protein ingredients as two samples that were identified positive for the presence of Salmonella.

FDA inspected Darwin’s again in June 2021. This time, the company cooperated fully with the inspectors, who noted a few observations of concern. These were corrected by company management before the inspection was completed, and no formal list of Inspectional Observations was issued.

The current situation

At the moment, there is no information available beyond what has been included in the company’s request for a temporary restraining order.

If the request is not granted, the FDA will be free to release additional details, including a Public Health Alert, if it chooses to do so.

In the interim, any consumer who suspects that a Darwin’s product may have caused his dog or cat to become ill should file a formal complaint with the FDA, using the agency’s pet food complaint portal.

For additional information on safety issues surrounding the feeding of raw pet food to companion animals, check out the FDA website

Learn more about a variety of food safety issues in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

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FDA finds Salmonella in three lots of Darwin’s raw dog food; cautions pet owners

This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission

The U.S. Food and Drug Administrations (FDA) cautioned pet owners not to feed certain Darwin’s Natural Pet Products raw dog foods after finding Salmonella in the products.

FDA collected and analyzed unopened packages from the products in response to a consumer complaint.

The products were manufactured by Arrow Reliance, Inc. (Arrow), a company based in Tukwila, Washington and doing business as Darwin’s Natural Pet Products.

The products that are affected by FDA’s alert to pet owners are:

  • 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 11, 2018
  • Darwin’s Natural Pet Products Natural Selections Turkey Recipe with Organic Vegetables for Dogs: 5339(11)181026, manufactured on October 26, 2018

Arrow has taken steps to remove these products from the marketplace, but has not issued a public notification, according to the FDA. The agency is concerned that the company’s customer notifications may not be effective, and is working with Arrow on recalling the remaining products from these lots.

In a statement released on its website today, Darwin’s expressed its disappointment in FDA’s decision to issue a public warning. The company also asserted its belief that its products do not pose any danger to either humans or pets, and stated that it had received no medical reports of illnesses attributable to these meals.

Animals infected with Salmonella may suffer symptoms that include vomiting, diarrhea (sometimes bloody), fever, loss of appetite and decreased level of activity. An infected animal may not exhibit any symptoms but may still shed the bacteria in its feces, passing the infection to human companions.

Salmonella can cause illness and death in humans and in animals. People infected with Salmonella may develop diarrhea, fever and abdominal cramps. The elderly, the very young, and individuals with weak immune systems are more prone to suffering severe symptoms, including secondary infections in other organs.

What consumers should do

  • If you have purchased one of the affected products, discard it in a secure container to prevent children, pets or wildlife from accessing it. * If you have had one of the affected products in your home, you 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. Remember to thoroughly wash your hands after handling the recalled product or cleaning up potentially contaminated items and surfaces.
  • If you or a member of your household becomes ill, contact your health care provider.
  • If you think your pet has become ill after consuming contaminated pet food, contact your veterinarian. 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

Human Salmonella illness linked to raw pet food

This story by Phyllis Entis was first published in Food Safety News and is reposted here with permission.

A confirmed case of Salmonella Infantis illness has been linked to a raw pet food manufactured by Arrow Reliance, Inc., dba Darwin’s Natural Pet Products (Darwin’s), according to updated information released by the U.S. Food and Drug Administration (FDA).

The infected individual is one of 92 people infected with a multidrug-resistant Salmonella Infantis outbreak since the beginning of 2018 according to the Centers for Disease Control and Prevention (CDC).

The individual reported having become ill after household pets ate raw ground chicken pet food manufactured by Darwin’s. According to a spokesperson for CDC, this individual did not report any pet illnesses.

The Salmonella Infantis outbreak has spread over 29 states and hospitalized 21 individuals.

Outbreak victims reported eating various brands and types of chicken products. A single, common supplier of either raw chicken products or live chickens has not been identified, according to CDC.

The outbreak strain has been recovered from samples of raw chicken products, from live chickens, and from raw chicken pet food.

According to a spokesperson for FDA, the outbreak strain is likely related to the Salmonella strain recovered from an adult dog that had recurring diarrhea as a result of consuming contaminated raw chicken dog food manufactured by Darwin’s.

The raw pet food fed to the infected dog also tested positive for Salmonella.

Darwin’s initiated a total of five voluntary recalls between October 17, 2016, and March 26, 2018, after being informed that Listeria monocytogenes, Salmonella, and E. coli O128 were found in some of the company’s raw pet food products.

CDC is reminding pet owners that Salmonella and other pathogenic bacteria in raw pet food can make pets sick. Household members also can become infected by handling the raw food or when caring for an infected pet.

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.