Midwestern Pet Foods and Nunn Milling Co. have agreed to pay US$6,375,000.00 to settle a Class Action brought against the companies by pet owners and breeders whose animals were sickened or died after consuming aflatoxin-contaminated pet foods.
Jeffrey Nunn, the CEO and co-owner of Midwestern Pet Foods, also is a co-owner of Nunn Milling Co.
A separate case, brought by Jeremy and Britany Simmons, was settled in March 2023. The details of that settlement have not been released.
The Backstory
The FDA received the first complaint about a Midwestern product on December 15, 2020.
On December 30, 2020, Midwestern Pet Foods issued a recall of certain SPORTMiX products, citing the presence of aflatoxin above permitted levels.
The following day, the FDA began an in-depth inspection of Midwestern’s Chickasha, Oklahoma production plant.
During its inspection, the FDA found that the company had accepted shipments of aflatoxin-contaminated corn, and had used that corn to manufacture pet foods.
The company expanded its product recall on January 11, 2021, after the states of Missouri and Texas documented extremely high levels of aflatoxin in multiple samples of the company’s dry dog and cat foods.
By March 15, 2021, the FDA had amassed complaints from 181 households and kennels, all reporting adverse effects in pets who had been fed a Midwestern product.
Ultimately, the FDA determined that more than 130 pet deaths and more than 220 pet illnesses could potentially be linked to consumption of a Midwestern dry pet food.
The FDA issued a formal Warning Letter to the company on August 9, 2021.
Class Action
Stephanie Romero, a Las Vegas resident, was among the first victims of Midwestern’s aflatoxin-contaminated pet foods to file a Complaint against the company.
On December 15, 2020, Stephanie purchased SPORTMiX dog food for her two dogs, and opened the first bag that same day.
The following day, Olive, her three-year old lab mix, appeared to be less active than usual. The dog’s health gradually deteriorated until, one week later, she began vomiting.
Olive suffered two seizures on Christmas Day, and Stephanie described her dog as being lethargic, disoriented and confused. She was continuing to vomit, and appeared to be jaundiced. Her urine was bright orange.
Stephanie brought Olive to her veterinarian, who determined that the dog’s organs were shutting down, and recommended euthanasia.
Upon returning home from the veterinarian, Stephanie discovered that her three-year old dachshund, Scotty, had vomited in her absence, and was lying on the floor next to a puddle of dark blood.
Stephanie rushed Scotty to the veterinarian, who determined that the dog was bleeding internally.
Scotty, too, was euthanized.
A few days later, Midwestern announced its first recall. When Stephanie learned of the recall, she checked her bag of SPORTMiX dog food. The lot code on the bag matched one of the recalled lots.
Stephanie alerted her veterinarian to the recall and filed a report with the FDA.
On January 19, 2021, Stephanie joined four other pet owners in filing suit against Midwestern Pet Foods.
Stephanie and her fellow Plaintiffs agreed to consolidate their action with suits filed by other pet owners.
In January 2023, almost two full years after the initial court filing, the parties reached agreement on a settlement.
On February 6, 2023, the Court issued a Preliminary Approval of the settlement agreement. A Final Approval hearing is scheduled for August 24, 2023.
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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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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