Sunday Supplement: Darwin’s Defies FDA (Op-Ed)

In a written response to a February 16, 2023, Warning Letter issued by the US Food and Drug Adminstration (FDA), Gary Tashjian, President of Arrow Reliance, Inc. (dba Darwin’s Natural Pet Products) has effectively told the federal agency to take a hike.

Tashjian’s letter to the FDA was obtained by eFoodAlert in response to a Freedom of Information Act request.

The FDA Warning Letter was issued following an August–September 2022 inspection of the company’s raw pet food manufacturing facility, located in Tukwila, Washington, and the finding of two different Salmonella serotypes (Typhimurium and Kentucky) in samples of the company’s products.

In the Warning Letter, the FDA cited three violations of the Federal Food, Drug & Cosmetics Act and regulations (FD&C Act).

Adulterated animal food (due to presence of Salmonella)
Use of Peroxyacetic Acid (PAA) in a manner not generally recognized as safe under the FD&C Act
Failure to register as a Food Facility as required under the FD&C Act

Tashjian’s formal response characterized all of the FDA’s citations as “…arbitrary and capricious, in excess of statutory authority and otherwise unlawful.”

Tashjian’s arguments

Salmonella

The 2022 inspection that culminated in the Warning Letter was initiated in response to a consumer complaint. A cat owner had fostered four kittens, and fed about a tablespoon full of a Darwin’s adult cat food to three of them.

All three kittens who ate the food became ill, and a stool culture from one of the kittens yielded Salmonella. The kitten that did not eat the food remained healthy. Salmonella also was recovered from a sample of the same production batch that was fed to the kittens.

Over the course of the past several years, Tashjian has repeatedly rejected the FDA’s policy of zero-tolerance for Salmonella and other pathogens in pet foods and treats, including raw pet food products.

His argument is that the FDA must shoulder the burden of proof in each individual instance where a pathogen is found.

According to Tashjian, it is not enough to find Salmonella in one of his company’s finished products, even when the serotype in question annually makes the CDC’s list of ‘top ten’ Salmonella serotypes associated with human illnesses (as is the case with Salmonella Typhimurium).

Tashjian has taken the position that the agency must document that the quantity of the precise genetic strain of Salmonella found in the sample will cause illness in an animal or a person.

Tashjian’s response to the contamination cited in the Warning Letter is (a) that the strain of Salmonella recovered from the sick kitten was not typed genetically and may have come from somewhere other than the food, and (b) that the owner should not have fed the product to her kittens, as it was labeled for adult cats.

Use of peroxyacetic acid (PAA)

The FD&C Act and its associated regulations includes a list of food additives and ingredients that are “generally recognized as safe” (GRAS) for specific circumstances and at specific maximum concentrations.

Peroxyacetic acid, which is formed when acetic acid is allowed to combine with hydrogen peroxide, is GRAS for certain food applications, including as an antimicrobial secondary direct food additive in human food, at a maximum concentration of 220 parts per million (220 ppm).

Darwin’s uses PAA as a pathogen mitigation tool in its raw pet foods, even though the chemical has not been approved for that purpose, according to the Warning Letter. Furthermore, the company increased the concentration of PAA added to its products to an amount exceeding the 220 ppm that is permitted under the GRAS regulation.

And it did so without submitting any documentation that the level it is using is safe for dogs and cats to consume.

Tashjian’s rebuttal is two-fold.

PAA is used as a processing aid in USDA-inspected plants and any raw poultry purchased by Darwin’s would likely have been treated with this product.
The two components of PAA are both GRAS for pet food; therefore it is unnecessary for the combination of the products to be GRAS.

He is silent on the company’s use of PAA at a higher concentration than has been recognized as safe for any food applications.

Food Facility Registration

Finally, Tashjian rejects the FDA’s assertion that he is obliged to register Arrow Reliance, Inc. as a Food Facility, arguing that his company is exempt from the requirement, as it sells its products directly to consumers and is, therefore, a retail food establishment.

In support of his position, he cites the FDA response to comments published in the Federal Register concerning the definition of “retail food establishment.” (see Federal Register 81(135):45923. 14 July 2016)

My rebuttal

Tashjian’s cavalier dismissal of the risk to human and animal health associated with Salmonella-contaminated pet food is disingenuous, at best.

His stance on the presence of Salmonella (and other pathogens) in his raw pet foods is akin to a driver who, having been ticketed for doing 90 miles an hour in a 60 mile-an-hour zone, demands that the police officer provide proof that his speed was unsafe for that specific stretch of road in the specific make and model of vehicle under the exact time of day and road conditions at the moment he was ticketed.

Pathogens in pet food

The presence of Salmonella in any pet food or pet treat, raw or processed, presents a risk to human and pet health.

While not all Salmonella serotypes and strains are alike in their ability to cause infection, low numbers of Salmonella have been documented to do so, depending upon the susceptibility of the person or animal who is exposed to the microbe and the nature of the food ingested, especially the fat and protein content of the food.

As I discuss in my new book, TOXIC, Salmonella-contaminated kibble has been responsible for two multi-state Salmonella outbreaks in the United States since 2006. Salmonella-contaminated pet treats have caused multiple outbreaks of human illness in the United States and Canada since the 1990s.

Documenting Salmonella infections in animals is more difficult than in humans, because there is no requirement for animal illnesses to be reported to the FDA, even when a veterinarian has made a diagnosis based on lab culture results. Nevertheless, on two widely separate occasions (2017 and 2022), a direct link was established between a Salmonella-infected animal and a Salmonella-contaminated Darwin’s raw pet food.

Peroxyacetic acid as a pathogen mitigation

There is a process in place for a company to submit documentation demonstrating the safety and efficacy of a new food additive or a new use for an existing additive. The FDA reviews the documentation and if the data support the proposal, the agency will grant its approval.

That did not happen in this case.

Darwin’s arbitrarily and unilaterally increased the amount of PAA it adds to its products to a level beyond the highest concentration that had been approved as safe for any food application.

Food Facility Registration

Is Arrow Reliance really exempt from the requirement of food facilities to register with the FDA?

The exemption on which Tashjian bases his claim is a “retail establishment exemption.” According to Tashjian, because Darwin’s sells directly to customers, the company meets the definition of a retail establishment. He cites a specific statement made by the FDA and published in the Federal Register (volume 81(135), page 45923) to support his claim.

Tashjian quotes the statement as including in the exemption “…larger establishments [that] can reach consumers on a national level”

Read in isolation, the statement appears to support Tashjian’s contention. However, when taken in context, it is clear that the FDA is referring to “…direct-to-consumer sales of foods from local farms and establishments closely associated with farms.”

Arrow Reliance is not located on a farm, owned by a farm, or closely associated with farms. The company is a free-standing, independent manufacturer and processor of raw pet foods.

What next for the FDA?

Science, the law and common sense come down on the side of the FDA.

In my opinion, the agency has two choices:

Continue along the well-trodden path of responding to future consumer complaints–and there will be future consumer complaints–with follow-up inspections, documentation of violations, and public alerts, all of which the company will either ignore or contest, or
Solicit the assistance of the Department of Justice and apply for an injunction to compel the company to adhere to the same rules as every other raw pet food producer must follow.

If the FDA does not take strong action against Arrow Reliance, a company that routinely over the years has refused to cooperate with FDA and state investigators, has applied to the courts in a failed attempt to prevent the FDA from exercising its legal authority, and has ignored or deliberately misconstrued the clear intent of various provisions of the FD&C Act and regulations, the agency will lose all credibility both with the industry it is charged with regulating and with the public it is supposed to protect.

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