“We are issuing this corporate-wide warning letter because inspections of Midwestern Pet Foods, Inc.’s manufacturing plants revealed evidence of violations, which were shared across multiple plants and were associated with the illness or death of hundreds of pets who had eaten the company’s dry dog food,” Steven M. Solomon, D.V.M., director of the FDA’s Center for Veterinary Medicine, said in a press release.
FDA agents first inspected Midwestern’s Chickasha plant. FDA agents also inspected the company’s three other manufacturing plants. These inspections revealed evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation. These inspections of pet food manufacturing sites revealed apparent violations of the Federal Food, Drug, and Cosmetic Act.
The initial inspection of Midwestern’s Chickasha, Oklahoma plant was triggered by reports of illness or death in dogs that had eaten SPORTMiX brand dry dog food manufactured by Midwestern. Samples of SPORTMiX were later found to contain levels of aflatoxin as high as 558 parts per billion (ppb). The FDA considers pet food to be adulterated if it contains more than 20 ppb of aflatoxin.
History of aflatoxin and Salmonella Midwestern Pet Foods recalls
Shortly before Christmas 2020, dogs began dying with symptoms of liver disease. A common factor among the dogs was eating SPORTMiX kibble. On Dec. 30, Midwestern Pet Foods recalled the dog foods involved. By January 11, more than 70 pets had died after eating the product. On that date, Midwestern expanded the recall to include all products meeting these three criteria: containing corn, manufactured in Oklahoma and with an expiration date on or before July 9, 2022. On January 25, the U.S. Food and Drug Administration announced a list of countries to which pet food containing dangerous levels of aflatoxin may have been exported by Midwestern Pet Foods, ranging Bahrain and Barbados to Uruguay and Vietnam. As of August 9, the FDA was aware of more than 130 pet deaths and more than 220 pet illnesses that may be linked to eating brands of pet food manufactured by Midwestern, although not all of these have been confirmed.
In March, Midwestern recalled several brands of pet food manufactured at its Monmouth, Illinois plant, after samples tested positive for Salmonella, including brands CanineX, Earthborn Holistic, Venture, Unrefined, Sportmix Wholesomes, Pro Pac, Pro Pac Ultimates, Sportstrail, Sportmix and Meridian brands produced at its Monmouth, Illinois production facility. In inspections, the FDA found that Midwestern’s food safety program appears inadequate to significantly minimize or prevent Salmonella in its pet food.
The FDA has requested a written response to the warning letter from Midwestern within 15 working days stating the specific steps they have taken to correct any violations. Failure to adequately address any violations promptly may result in legal action, including product seizure and/or injunction.
Toxicologist, vet catch dog food toxin after early deaths
On the dry plains of the American West, Aspergillus fungus found the right conditions for colonizing corn kernels weakened by drought or improperly stored. That fungus released a poison, or mycotoxin, into the grain. That corn was used to produce contaminated pet food.
Shortly before Christmas 2020, dogs began dying with symptoms of liver disease at a southern Missouri dog breeding kennel. Veterinarian David Sikes sent dog food samples to his former professor Tim Evans, animal toxicologist at the University of Missouri. The dog food, Sportmix High Energy brand, tested positive for high levels of aflatoxin, a mycotoxin found in drought-stressed corn or harvests stored in humid conditions. Sikes recognition of symptoms and Evans’ analysis may have caught the aflatoxin-contaminated dog food early, potentially saving lives.
“Aflatoxins are heavily regulated,” Evans said. “Generally, there is an appropriate representative testing occurring before incorporation of goods, and in many instances in the finished product. Somehow, those policies were either ineffective or not followed. I know no more details than that.”
On Dec. 30, the product’s maker Midwestern Pet Foods recalled the dog foods, which had already been distributed in both brick-and-mortar and e-commerce channels. By January 11, more than 70 pets had died after eating the product, according to reports submitted to FDA. On that date, Midwestern expanded the recall to include all products meeting these three criteria: containing corn, manufactured in Oklahoma and with an expiration date on or before July 9, 2022.
That location and date may have been the key to this deadly recall.
“Aflatoxins and other fungal toxins are commonly produced under particular weather conditions,” Evans told Petfood Industry. “Aflatoxins in particular are produced under drought conditions. Under drought conditions the fungus gains access to the corn. Then the hot and moist conditions that result in toxin production can occur in the field, or can occur in storage conditions.”
Oklahoma’s dry environment may have contributed to the risk. Portions of western and southern Oklahoma ranged from abnormally dry to extreme drought in 2020, according to the University of Nebraska U.S. Drought Monitor.
“All of the contaminated products came out of Midwestern Pet Foods’ plant in Chickasaw, Oklahoma,” Evans said. “Oklahoma is very frequently under drought conditions. It’s not unexpected that there might be contamination.”