Toxic levels of vitamin D in Hill’s Pet Nutrition (Hill’s) canned pet foods and Sunshine Mills (Sunshine) dry pet foods could have been prevented, had both companies followed their own food safety plans.

According to information obtained by Food Safety News in response to Freedom of Information Act (FOIA) requests, Hill’s identified Vitamin Premix as a ‘high risk’ chemical hazard and required that the ingredient “…be analyzed and be within acceptable limits prior to unloading … into the manufacturing facility.”

The company was unable to provide analytical test results for Vitamin Premixes during a February 2019 inspection.

The inspection was undertaken by the U.S. Food and Drug Administration (FDA) in response to the January 31, 2019 Hill’s recall of canned pet foods due to excess levels of vitamin D.

Tests conducted on a retained sample of the premix revealed a level of vitamin D that was roughly 30 times the target range for this ingredient. As of February 11, 2019, the company acknowledged having received 85 consumer complaints reporting pet deaths.

The number of complaints received by the company has increased substantially since that date, according to information supplied to FDA by Hill’s in response to FDA’s inspection observations.

FDA declined to comment on the number of pet deaths. According to an agency spokesperson, FDA is still in the process of verifying details of the complaints it has received, and considers it would be “…premature to release a number until the cases have been vetted to ensure they are all related to recalled product and are indeed cases of vitamin D toxicity.”

Hill’s cited a manufacturing error on the part of its vitamin premix supplier as the cause for the excessive vitamin D levels in its canned pet foods. The company is reevaluating and strengthening its specifications, including requiring a Certificate of Analysis for each incoming shipment of vitamin and trace mineral premixes.

In December 2018, FDA issued an alert to pet owners regarding a series of dry dog food recalls for excessive vitamin D levels. As reported by Food Safety News, FDA received a total of six dog illness reports associated with the recalled products.

The dry dog foods were manufactured by Sunshine Mills and sold under several brand names.

An ordering error by a Sunshine employee caused the wrong Vitamin D ingredient to be shipped to the company.

According to FDA, Sunshine did not follow its own written procedures for receiving ingredients. The company neither obtained a Certificate of Analysis for the ingredient, nor conducted its own testing to determine whether the Vitamin D it received was the correct concentration for use in dog food.

The error resulted in a level of Vitamin D in the finished dog foods of as much as 70 times the target amount.

Sunshine was notified on October 23, 2018 about a consumer complaint reporting an ill dog that had eaten one of the company’s dry dog foods. Sunshine investigated the complaint and concluded on November 2nd that it was valid.

FDA requires validated complaints to be reported within 24 hours; however, Sunshine did not submit a ‘reportable food report to FDA until six days later, on November 8, 2018.

Although the sources of elevated vitamin D were different in these two situations, the course of events was similar.

Both Hill’s and Sunshine took delivery of an ingredient that was substantially higher in vitamin D than specified for the purpose.

Both Hill’s and Sunshine had written procedures in place for receiving raw materials, and these procedures mandated testing for vitamin D concentration.

Neither Hill’s nor Sunshine carried out the lab analysis mandated in their written procedures.

 Neither Hill’s nor Sunshine required a Certificate of Analysis for their Vitamin D ingredient or premixes.

Had Hill’s and Sunshine followed their own written procedures, the incorrect vitamin D ingredient concentration would have been found before the ingredient was used.

FDA’s investigation into Hill’s is ongoing, according to an agency spokesperson.

FDA offers the following information regarding vitamin D toxicity to pet owners and veterinarians.

If your pet is having symptoms of vitamin D toxicity, contact a veterinarian immediately. Provide a full diet history to your veterinarian. You may find it helpful to take a picture of the pet food label, including the lot number.

Don’t feed the recalled products to your pets or any other animal. Contact the company listed on the package for further instructions or throw the products away in a way that children, pets and wildlife cannot access them.

Consumers can report suspected illness to the FDA electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. It’s most helpful if you can work with your veterinarian to submit your pet’s medical records as part of your report. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.

The FDA encourages veterinarians treating vitamin D toxicity to ask their clients for a diet history. We also welcome case reports, especially those confirmed through diagnostics. You can submit these reports electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.

 Veterinarians should also be aware that vitamin D toxicity may present as hypercalcemia, similar to dogs that have consumed rodenticide. In these cases, FDA suggests that veterinarians confirm diet history to verify whether the dog has been eating any of the recalled products.