Between August 2021 and August 2022, Primal Pet Foods, Inc.’s internal finished product testing program found forty-nine (49) pathogen-positive finished product samples, according to a Warning Letter released this week by the U.S. Food and Drug Administration (FDA).

Primal Pet Foods, Inc. (Primal) is a manufacturer of raw frozen and raw freeze-dried dog and cat foods, toppers, and treats based in Fairfield, California.

On July 6, 2022, Primal announced a recall of a single production lot of Raw Frozen Primal Patties for Dogs, Beef Formula (Lot #W10068709) after routine sampling by the FDA found Listeria monocytogenes in the product.

As a follow-up to the recall, the FDA visited the company’s Fairfield manufacturing facility on July 14, 2022, to begin an inspection that continued until October 11th.

During the course of the inspection, FDA investigators documented a large number of troubling issues

What the FDA found

The failures summarized in the Warning Letter and on the FDA Inspections Database include problems with preventive controls, supplier verification, record keeping, and inadequate monitoring.

Preventative controls that did not prevent pathogens

Primal’s food safety program includes adding a probiotic to its freeze-dried products as a preventative control for Salmonella.

Probiotics are so-called “good” bacteria found in the digestive system. They play an important role in digestion and also help to prevent pathogens from taking up residence in the large intestine.

When the FDA reviewed Primal’s documentation purporting to validate the effectiveness of the probiotic, they found significant flaws in the validation study, including the use of a relatively insensitive method for detecting residual Salmonella.

The FDA maintains a zero-tolerance policy for Salmonella and other pathogens in all pet foods, and the standard method used by government and industry labs is able to find a single living Salmonella cell in 25 grams of sample. Yet the method used by Primal’s lab to support their validation study was only able to find Salmonella if it was present at a level of 10 or more Salmonella cells per gram.

Furthermore, the company offered no evidence that its probiotic control would have any effect at all on other pathogens, such as Listeria monocytogenes or E. coli O157:H7.

As further proof that the probiotic control was not working, the FDA cited Primal’s own records of 49 pathogen-positive production lots over a one-year period. An average of just under one contaminated batch per week.

Inadequate response to contaminated and out-of-compliance products

Primal’s standard operating procedure specified a maximum level for Vitamin D of 3000 International Units per kilogram (IU/kg). Yet the company shipped a batch of freeze-dried dog food containing 3410 IU/kg–more than 10% above the maximum specified level. And it did so before the sample of this batch even reached its third-party lab for testing.

Primal’s standard operating procedure also specified a minimum level for thiamine–an essential vitamin for cats–of 5.6 mg/kg in its feline diets. Yet the company shipped a batch of freeze-dried cat food containing only 3.96 mg/kg. Again, the product was shipped even before the sample reached the lab.

Primal found Salmonella and/or Listeria monocytogenes in its finished products on 49 occasions during a one-year period, according to the company’s own records. There is no information in the Warning Letter as to what happened to those 49 contaminated production batches.

The only publically announced product recall occurred as a result of the FDA having found Listeria monocytogenes in a routine surveillance sample.

After learning of the FDA’s findings, the company issued a public recall. Yet it took no steps to evaluate the safety of other pet foods manufactured on the same production line immediately before and after the recalled batch.

Unhelpful response to records requests

Primal did not promptly provide all required records when requested to do so by the FDA investigator, impeding the ability of the FDA to complete its inspection and evaluation in a timely fashion.

It is unclear from the limited information available in the Warning Letter and the FDA Inspections Database whether or not the company eventually supplied all of the requested documentation.

What happens next?

The Warning Letter was dated February 21, 2023.

The company was been given the standard fifteen (15) working days following receipt of the letter in which to respond in writing with specific steps taken to correct the list of violations, including copies of related documentation to support its corrective measures.

The ball is now in Primal’s court.

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Last month, the US Food and Drug Administration (FDA) fired the latest salvo in an ongoing battle between the government and Arrow Reliance Inc. (dba Darwin’s Natural Pet Products), a manufacturer and distributor of raw pet food.

On February 16, 2023, the FDA sent a formal Warning Letter addressed to the company’s owner, Gary T. Tashjian.

In that letter, the agency summarized the violations its investigators observed during an August/September 2022 inspection of the company’s manufacturing facility, located in Tukwila, Washington.

The inspection was triggered by a consumer complaint. The consumer informed the FDA that her three kittens had developed diarrhea after consuming about one tablespoon each of a Darwin’s Natural raw cat food.

A stool sample from one of the kittens tested positive for Salmonella.

The FDA obtained three unopened packages of Darwin’s cat food from the complainant’s home. Two of those packages tested positive for Salmonella Typhimurium, and one of those two packages also was contaminated with Salmonella Kentucky. Both of these serotypes are capable of causing human illness, and have been responsible for foodborne disease outbreaks in the United States and other countries.

The agency also collected a sample of cat food at the production plant during the course of its inspection. That sample, too, was positive for Salmonella Typhimurium.

The FDA holds raw, ready-to-eat pet foods to the same zero-tolerance standard for pathogens as it does all other forms of pet food.

Upon confirming the presence of Salmonella in the company’s products, the FDA urged Darwin’s to initiate a voluntary recall.

The company refused.

The FDA advised Darwin’s that, in the absence of a recall, the agency would post a consumer advisory on its website to warn the public about the contaminated batches of pet food.

In response, Darwin’s sought a court injunction to prevent the FDA from posting its advisory.

The court denied the injunction, and the FDA posted its advisory on August 5, 2022.

The opening salvoes

The war between Darwin’s and the FDA began in earnest in September 2017, when Darwin’s recalled a batch of cat food due to Salmonella contamination.

The recall was initiated as a result of a consumer complaint to the FDA involving a dead kitten. Darwin’s undertook the recall after an FDA lab confirmed the presence of Salmonella in an unopened package of the same batch of food the kitten had been fed.

In December 2017, the company recalled certain batches of raw cat food and raw dog food after lab testing found Salmonella and Listeria monocytogenes in samples of the products.

Later that same month, the FDA received yet another consumer complaint, this time involving a German Shepherd named Blitz, who had been suffering from severe, protracted diarrhea for several months. The dog’s owner had been assured by Darwin’s that the production lots of food they had supplied to her were not implicated in the product recall, and were “safe” for her to feed to her dog.

Upon learning about the recalls, Blitz’s owner arranged for his stool to be tested for Salmonella. It was positive, as was an unopened package of the dog food collected from her home by an inspector with the FDA.

In response to this and other complaints, the FDA and the Washington Department of Agriculture initiated a joint investigation of Darwin’s manufacturing facility.

On April 2, 2018, the FDA issued its first Warning Letter to the company. In it, the agency addressed a series of violations, including the presence of Salmonella, Listeria monocytogenes, and E. coli O128 in samples of finished products and the use of an additive that was not “generally recognized as safe” for pet foods.

The Warning Letter also addressed the consumer complaint involving the dead kitten. The strain of Salmonella recovered from the kitten on necropsy was genetically identical to the strain of Salmonella found in an unopened package of cat food from the same batch the kitten had eaten, and also matched Salmonella found in two other products sampled during the inspection of the manufacturing facility..

The second round

In March 2019, in response to yet another consumer complaint, the FDA collected and analyzed samples of three different batches of Darwin’s raw dog food.

When the agency’s lab found Salmonella in all three batches, Darwin’s recalled the products by notifying the recipients of those specific batches by email.

The company declined to cooperate with the FDA’s efforts to ensure an effective recall.

As a result, the FDA posted a consumer advisory on its website.

Darwin’s responded to the advisory by posting a statement on its own website. In its statement, the company denied that its products posed any danger to people or to animals, and said that it had received no medical reports of illnesses attributed to the recalled products.

Darwin’s also claimed that the FDA issued the consumer advisory “in retaliation” for the company’s refusal to share customer contact information.

The Covid-19 lull

The restrictions placed upon the FDA’s ability to conduct on-site investigations during the Covid-19 pandemic greatly reduced the agency’s ability to monitor the activities of Darwin’s.

An inspection carried out in 2021 proceeded only after a one-week notice to the company, and found little.

Even so, FDA investigators determined that Darwin’s was still using an additive–albeit a different one–that was “not recognized as safe” for the purpose.

Worse, between 2021 and 2022, Darwin’s increased the concentration of the additive (known as peroxyacetic acid, or PAA) to well beyond the level determined to be safe for any food application, animal or human.

The bottom line

The issues raised in the FDA’s 2022 Warning Letter are serious.

The company’s decision to increase the level of PAA in its products to a concentration significantly beyond the recognized safe level for any application displays a flagrant disregard for the safety of its four-legged consumers.

The company’s denial that Salmonella in its products presents a health risk to either people or animals is disingenuous.

The company’s denial of FDA jurisdiction over its products has been shot down in federal court.

As the years have passed, the position taken by Darwin’s and its owner, Gary Tashjian, has become more and more adamant. The company has not even complied with its obligation to register with the FDA as a Food Facility.

In its Warning Letter, the FDA put the company on notice that its failure to address the issues raised in the letter “…may lead to legal action, including, without limitation, seizure and injunction.”

Unfortunately, initiating these legal actions requires the cooperation and involvement of the Department of Justice (DoJ).

There is precedent for such action. In 2022, the DoJ obtained a Permanent Injunction against another repeat offender, Bravo Packing, Inc. But that came only after the FDA and Animal Outlook, a non-profit animal advocacy organization, documented multiple egregious violations of animal welfare and manufacturing practices on the part of the company and its owner.

Evidence in the Bravo Packing case included cats urinating on meat destined for dog food, and the owner spitting on the production room floor as he accompanied the FDA inspector on his rounds on two separate visits.

Is that what it will take for the DoJ to get on board for Darwin’s?

How many more dogs and cats will have to die or suffer from severe illnesses before the FDA and the DoJ can be persuaded to act?

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