FDA In Brief: FDA Issues a Corporate-Wide Warning Letter to Company Associated with Contaminated Pet Food, Hundreds of Adverse Events
For Immediate Release:August 17, 2021
The following quote is attributed to Steven M. Solomon, M.P.H., D.V.M., director of the FDA’s Center for Veterinary Medicine
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
For Immediate Release:August 17, 2021
The following quote is attributed to Steven M. Solomon, M.P.H., D.V.M., director of the FDA’s Center for Veterinary Medicine
Additional Information
- The U.S. Food and Drug Administration has issued a corporate-wide warning letter to Midwestern Pet Foods, Inc. after inspections of its manufacturing sites revealed apparent violations of the Federal Food, Drug, and Cosmetic Act that were shared across the sites. These conditions likely contributed to the illness or death of hundreds of dogs.
- 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.
- In January, the company voluntarily recalled these products, as well as all corn-containing pet foods manufactured at its Chickasha plant. In March, Midwestern recalled several brands of pet food manufactured at its Monmouth, Illinois plant after samples tested positive for Salmonella. The FDA found that Midwestern’s food safety program appears inadequate to significantly minimize or prevent Salmonella in its pet food. None of the recalled products should be available to consumers to purchase. A complete list of the products recalled by Midwestern can be found in the links below.
- Aflatoxins are toxins produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxins can cause illness and death in pets.
- As of August 9, the FDA is 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. Not all of these cases have been confirmed as aflatoxin poisoning through laboratory testing or veterinary record review. This count is approximate and may not reflect the total number of pets affected.
- After inspecting Midwestern’s Chickasha plant, the FDA 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.
- The FDA has requested a written response from the company 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.
- Warning Letter
- FDA Alert: Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin | FDA
- Midwestern Pet Foods Voluntarily Recalls Pet Food Recall for Aflatoxin Health Risk | FDA
- Midwestern Pet Foods Voluntarily Recall Due to Possible Salmonella Health Risk | FDA
- Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed | FDA
- Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals
- Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
- How to Report a Pet Food Complaint | FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
