ROCKVILLE, MD. — The US Food and Drug Administration (FDA) on Aug. 9 issued a company-wide warning letter to Midwestern Pet Food addressing significant violations of the Food, Drug and Cosmetics (FD&C) Act uncovered across all manufacturing sites. These violations were related to two recalls issued by the company in the last year, of which one resulted in at least 130 dog deaths. The agency threatened legal action, “including product seizure and/or injunction,” if the issues are not sufficiently addressed.

The warning was spurred by a voluntary recalls issued by Midwestern Pet Food on Dec. 30, 2020, due to potentially deadly levels of aflatoxins in several Sportmix pet food products and other brands manufactured by the company at its Chickasha, Okla. facility. As of Aug. 9, the FDA was aware of more than 130 deaths and over 220 illnesses among dogs linked to that aflatoxin recall. The agency stated this as an approximate count which “may not reflect the total number of pets affected.”

Aflatoxin levels in the pet foods associated with this recall were as high as 558 ppb, according to testing conducted by the Missouri Department of Agriculture, the Office of the Texas State Chemist and the FDA. The agency stated it considers any pet food products containing 20 ppb of aflatoxin are considered adulterated.

This recall prompted an inspection of the company’s four production facilities in Chickasha, Monmouth, Ill., Evansville, Ind., and Waverly, N.Y. between Feb. 1 and April 16. The inspections revealed significant, across-the-board violations of Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls, the agency stated.

Midwestern Pet Foods issued another voluntary recall on March 26, 2021, warning consumers that certain lots of 104 dog and cat food brands manufactured by the company could be contaminated with Salmonella, which were manufactured at its facility in Monmouth. This recall was cause for an inspection of that Illinois facility, in which the FDA discovered Midwestern Pet Food’s food safety program was “inadequate to significantly minimize or prevent Salmonella in its pet food.”

According to the letter, Midwestern Pet Food told the FDA that it tests corn products for aflatoxins in-house upon receiving those ingredients, but the agency found improper sample preparation procedures were being used for this preventive control, causing them to be unreliable.

Additionally, the letter stated that Midwestern Pet Food collected samples for nine lots of finished Sportmix and Earthborn pet food products to conduct in-house and third-party testing for Salmonella. The in-house samples were “presumptively Salmonella-positive,” a finding that was corroborated by the third-party laboratory, but a portion of seven of those lots were still distributed.

Following both the aflatoxin and the Salmonella recalls, Midwestern Pet Food provided explanations of procedures and actions taken to reduce future food safety risks to the FDA, but the agency reported those responses did not include adequate information or supporting documentation to determine whether the corrective actions would be enough.

“You [Midwestern Pet Food] have not provided documentation showing that you have adequately implemented your preventive control for mycotoxins that will significantly minimize or prevent this hazard,” the letter stated. “You also have not provided documentation showing that you have adequately implemented preventive controls for Salmonella to prevent the recontamination of product (b)(4) from reoccurring at your IL facility or occurring at your other three facilities. Therefore, we are unable to fully assess your corrective actions.”

Company leaders are expected to respond to the warning letter with a list of specific corrective actions and documentation to prove those actions or, if it does not believe it is in violation of the FD&C Act, provide reasoning and supporting evidence for consideration by the FDA. Failure to respond could result in legal action.

“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,” said Steven M. Solomon, MPH, DVM, director of the FDA’s Center of Veterinary Medicine (CVM). “Samples of dog food were found to contain high levels of aflatoxin. It is imperative that manufacturers and distributors of pet foods understand their responsibility to comply with all requirements of federal law and FDA regulations and, when applicable, to implement a robust hazard analysis and risk-based preventive controls program. We’ll continue to hold companies accountable and protect animal health as a core element of the FDA’s public health mission.”

The letter was addressed to Jeffrey Nunn, president, chief executive officer and co-owner of Midwestern Pet Food, but also sent to Richard Nunn, vice president and co-owner, and three plant managers for the company’s US facilities.

Read the full warning letter here.

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