Following Multiple Violations, FDA Demands Action From Raw Pet Food Manufacturer

Arrow Reliance Inc., doing business as Darwin’s Natural Pet Products—a raw pet food manufacturer based in Tukwila, Washington—has issued 5 pet food recalls since October 2016. Four of those recalls were due to potential Salmonella and/or Listeria monocytogenes contamination, and 1 was due to potential Shiga toxin—producing Escherichia coli O128 contamination.

Now, the FDA is putting its foot down.

In a formal warning letter issued Monday, the FDA said it will give Darwin’s 15 business days to explain the steps the company has taken to correct its many violations and to prevent similar violations from occurring in the future.

An investigation and inspections of Darwin’s Tukwila production plant by both the FDA and the Washington State Department of Agriculture were conducted following customer complaints regarding the company’s raw pet food products. One complaint was from the owner of a kitten that died from “severe systemic Salmonella infection” after ingesting Darwin’s Natural Selections Duck Meals for Cats.

Multiple unopened samples of Darwin’s products subsequently retrieved from customers and from the company’s manufacturing facility were found via whole-genome sequencing to be contaminated with Salmonella, Listeria, and/or E coli O128.

The letter also noted that Darwin’s uses a bacteriophage product to control pathogens in its raw pet foods. However, the FDA stated that it is “unaware that [bacteriophage products] are generally recognized as safe,” nor are they a regulated additive permitted in animal foods.

Besides finding evidence of pathogen contamination at Darwin’s production facility, the investigation also found that Darwin’s officials were aware of Salmonella contamination at the plant.

According to a draft inspection report, Gary T. Tashjian, president and owner of Darwin’s, told investigators the company had not received any customer complaints regarding Salmonella, Listeria, or E coli. But inspectors discovered that from January 5 to December 5, 2017, the company had, in fact, logged 332 complaints, pertaining to things such as foreign material, spoiled and leaking packages, and pet illnesses and death.

Based on its findings, the FDA considers the inspected Darwin’s products “adulterated,” meaning they contain a poisonous or deleterious substance that makes them injurious to health. Introducing adulterated food into interstate commerce violates the Federal Food, Drug, and Cosmetic Act.

If Darwin’s fails to implement lasting corrective actions, the FDA warned that it may take further regulatory action, potentially including seizure and injunction, without further notice.

To read the FDA warning letter, visit the FDA website.