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.