FDA warns Darwin’s in follow-up to sick cat complaint

The US Food and Drug Administration (FDA) has issued a stern warning to Arrow Reliance Inc. (doing business as Darwin’s Natural Pet Products), following what the agency referred to as an “inadequate” response to violations of the Food Drug and Cosmetics Act (FD&C Act) documented during an August-September 2022 inspection.

The inspection was carried out in response to a consumer complaint received by the FDA, in which the consumer reported that a Darwin’s cat food had caused illness in three kittens. The consumer provided documentation that a stool sample from one of the kittens tested positive for Salmonella.

Background

On July 8, 2022, the FDA was contacted by a consumer who complained that Darwin’s cat food had made her three kittens ill.

The FDA collected unopened packages of the suspect food from the consumer and found Salmonella in two samples.

With the Salmonella-positive results in hand, the FDA urged Darwin’s to initiate a recall of the contaminated products.

The company refused, and the FDA advised Darwin’s that the agency would issue a public caution.

On July 29, 2022, Darwin’s filed a request in federal court for a temporary restraining order to prevent the FDA from releasing information about the contaminated products to the public.

The court rejected the company’s request, and on August 5, 2022, the FDA finally was able to issue a caution to pet owners, advising them not to feed certain Darwin’s cat foods to their pets due to Salmonella contamination.

On August 23, 2022, the FDA began an inspection of Darwin’s manufacturing facility and, on September 30, 2022, handed a completed list of Inspectional Observations (FDA Form 483) to the company.

The company’s Director of Quality replied to the list of observations on October 14th.

What Darwin’s claims

Darwin’s claims that its Salmonella-contaminated raw pet foods are not adulterated, because (a) the microbe is not an “added substance,” and (b) it is up to the FDA to demonstrate that the Salmonella is present at a level that makes it “ordinarily injurious” to the intended consumer.

In its filing for the temporary restraining order, the company made reference to USDA enforcement policies for Salmonella and questioned why it should be acceptable for the pathogen to be present in raw poultry, beef and other meats for human consumption, but not in pet food.

Unresolved issues

1. Adulterated Animal Food

The FDA collected and analyzed unopened samples from the complainant.

One of the samples contained Salmonella Typhimurium, a serotype well known to cause both human and animal illness.

A second sample contained both Salmonella Typhimurium and Salmonella Kentucky, another serotype known to cause disease.

A third sample collected during the inspection of Darwin’s manufacturing facility also yielded Salmonella Typhimurium.

Because Salmonella can cause serious–sometimes fatal–illness in humans and in animals, the FDA considers the presence of the microbe at any level to be hazardous if the food is meant to be consumed without cooking.

Therefore, the three lots of Salmonella-contaminated cat food were adulterated within the meaning of the FD&C Act, according to the Warning Letter.

2. Use of an Unapproved Food Additive

In 2021, the FDA expressed its concern to Darwin’s regarding the company’s use of peroxyacetic acid (PAA) as an additive to control pathogens in its raw pet foods, as the chemical was not “generally recognized as safe” (GRAS) for the intended use.

During the 2022 inspection, the FDA observed that PAA was still being added to the pet foods, and that the company had increased the level of PAA to a concentration significantly higher than the recognized maximum safe level for its use in any food.

The FDA was unable to find any scientific data to indicate that the concentration of PAA incorporated into Darwin’s pet foods was safe for dogs or cats to consume.

The agency also reviewed documentation of a third-party lab study, undertaken on Darwin’s behalf, to validate the ability of PAA to control pathogens in the company’s raw pet foods. The FDA concluded that the level of pathogen control demonstrated during the study was inadequate to ensure a pathogen-free state in the company’s finished products.

3. Food Facility Registration

Under the FD&C Act, Darwin’s is required to register with the FDA as a “food facility.”

The company has long insisted that it supplies its products directly to customers and, as a “retail food establishment,” is exempt from this mandate.

However, Darwin’s ships the majority of its products to customers through third-party warehouses rather than directly from its manufacturing facility. Therefore, the company does not meet the definition of “retail food establishment” under the FD&C Act.

What happens next?

The company was given fifteen (15) working days to respond to the issues raised in the Warning Letter.

In the absence of a satisfactory response, the FDA may undertake legal action, including the possibility of seizure of products and/or seeking an injunction against the company.

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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).

The 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

Darwin’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