The New York Times  and other news outlets reported last week that the US Food and Drug Administration had issued a corporate-wide warning letter to Midwestern Pet Foods in part because it’s Sportmix brand of dry dog food had been linked to the deaths of 130 dogs and that its products may have sickened an additional 220 pets due to elevated levels of aflatoxin.  

Aflatoxins are poisonous substances produced by certain kinds of fungi that are found naturally the world over. The main fungi that produce aflatoxins are Aspergillus flavus  and Aspergillus parasiticus, which can contaminate food crops such as corn used in the manufacture of pet food.  

But the warning letter is only the latest step in a story that’s been unfolding since late last year when Midwestern issued a voluntary recall of Sportmix pet food on December 20, 2020. As well as being dangerous to pets, aflatoxins pose a serious health threat to humans and livestock. The company expanded their recall in January to include all dog and cat pet food products that contain corn and were made in their Chicashaw, Oklahoma, manufacturing plant.  

Upon subsequent investigation, the FDA also found evidence of Midwestern products contaminated by Salmonella, which prompted an additional voluntary product recall in March of this year. 

Steven Solomon, DVM, the director of the FDA’s Center for Veterinary Medicine, said in a statement that inspections of Midwestern’s manufacturing plants had “revealed evidence of violations” that were “associated with the illness or death of hundreds of pets who had eaten the company’s dry dog food.” 

Last week’s warning letter put the company on notice that simply recalling contaminated products wasn’t enough, and that it was time to actually do something about the problem: “Recalling product does not prevent the reoccurrence of a hazard in your pet food. It is your responsibility to prevent adulterated product from entering the animal food supply through a robust hazard analysis and risk-based preventive controls program.” 

A source at the FDA, speaking on background, told NEWStat that warning letters, including corporate-wide warning letters, are advisory actions and are intended to give companies an opportunity to take “voluntary and prompt corrective action” to address any violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). “Warning letters inform the firm of FDA’s position on a matter but do not commit the Agency to taking enforcement action,” they added. “Firms often come into compliance after receiving a warning letter.”   

The FDA conducts follow-up inspections after issuing warning letters to verify that a firm has taken any appropriate actions needed to bring their facility into compliance. If the Agency’s follow-up reveals that a firm has failed to promptly make needed corrections or has failed to sustain those corrections, the FDA may take additional actions, which according to the letter to Midwestern Pet Foods, include legal action "without limitation, seizure, and injunction.”   

The FDA gave the company 15 working days to respond. 

Photo credit: © busypix/E+ via Getty Images