FDA warns Hill’s that vitamin D dog food reply deficient

The U.S. Food and Drug Administration (FDA) sent a warning letter to Hill’s Pet Nutrition on November 20, related to the company’s recall of wet dog food for dangerously excessive vitamin D content. The letter documented two federal inspections of the pet food company’s facility and the testing of recalled canned dog food. The agency gave Hill’s 15 working days to send their own letter back about how the company would respond to the noted violations.

Background of FDA investigation into recalled dog food

Hill’s recalled 25 varieties of dog food in January followed by eight more in March. The FDA conducted inspections of Hill’s pet food manufacturing facility in Topeka, Kansas, USA. Those inspections occurred February 1-19 and March 25-27, in response to Hill’s “recall of products marketed with toxic levels of vitamin D.” FDA also obtained samples of Hill’s canned dog food in February for testing.

“The inspections and the investigation confirmed that animal food products with unsafe levels of vitamin D were manufactured and marketed by your firm,” Cheryl Bigham, district director for FDA
Office of Human and Animal Foods, wrote in the letter. “You determined the unsafe levels of vitamin D were the result of an ingredient that you received and accepted in a manner not in accordance with your receiving procedures, and that was subsequently incorporated in the animal food products.”

FDA officials considered Hill’s recalled dog food to be adulterated because the unsafe amounts of vitamin D were “a food additive that is unsafe within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” FDA inspectors also found violations of the agency’s Hazard Analysis and Risk-Based Preventive Controls requirements for animal food.

Details of FDA investigation into vitamin D levels in Hill’s dog food

FDA laboratories found vitamin D at levels more than 33 times the recommended safe upper limit in samples of Hill’s recalled dog food. The agency tested two lots of Hill’s Prescription Diet Digestive Care i/d Low Fat (SKU Number 10423) canned dog food. In those samples, vitamin D ranged from 100,170 to 107,282 IU/kg and from 102,829 to 102,346 IU/kg the pet food.

“According to literature reviewed and summarized by scientific committees in the National Research Council, and the 2017 Official Publication of the Association of American Feed Control Officials on pages 149-162, vitamin D in dog food is safe in the amount of 500 to 3,000 IU/kg,” Bigham wrote. “According to the scientific literature, concentrations of vitamin D in dog food above 4,000 IU/kg dry matter cause signs of vitamin D toxicosis, with severity of signs increasing with increasing concentrations of the vitamin.”

While Hill’s has implemented procedures to address the potential for another vitamin D problem, Bigham noted remaining problems.

“We are unable to assess the adequacy of your corrective actions because many are preexisting procedures that were not followed consistently prior to the recall event,” she wrote.

Bigham acknowledged Hill’s efforts to ensure personnel followed food safety procedures, but concluded that Hill’s response did “not address the root cause of this incident, which was accepting an ingredient without confirming that it contained vitamin levels that were within specification as required by your procedures.”