LENEXA, Kan. — The US Food and Drug Administration (FDA) on Nov. 20 issued a warning to Hill’s Pet Nutrition after a number of its wet dog food products were found to have toxic vitamin D levels. Upon inspection, the agency found the pet food company was not following its food safety plan, causing unsafe vitamin premix to be included in 85 lots of wet dog foods in its Prescription Diet and Science Diet lines.
The FDA conducted complaint-related inspections of Hill’s production on Feb. 11 and 23, followed by a series of investigations between Feb. 19 and March 25, 2019.
“The unsafe amounts of vitamin D cause your products listed below to be adulterated because they bear or contain a food additive that is unsafe within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act),” the agency wrote in its letter to Hill’s.
The FDA reported vitamin D levels as high as 107,282 IU per kg of vitamin D in one lot of Hill’s Prescription Diet Digestive Care i/d Low Fat canned dog food product and cited another lot of the same product for including vitamin D levels as high as 102,346 IU per kg.
According to the Association of American Feed Control Officials’ (AAFCO) 2017 Official Publication, vitamin D levels for dog foods are safe if maintained between 500 and 3,000 IU per kg.
“Although vitamin D is an essential nutrient that allows dogs to regulate the balance and retention of calcium and phosphorus, when high levels of vitamin D are consumed, excessive amounts are not excreted but are stored in fat tissue and the liver,” causing adverse health consequences, the FDA stated.
The agency also said it found the products to be adulterated, according to the FD&C Act, as the FDA found Hill’s in violation of its Hazard Analysis and Risk-Based Preventive Controls requirement for animal food. Specifically, the FDA cited Hill’s for failing to “sufficiently assess the probability that a vitamin D toxicity or deficiency hazard will occur in the absence of a preventive control.”
According to the FDA, the pet food company did not implement a prerequisite program to ensure the vitamin premix it was supplied contained safe levels of vitamin D. The agency pointed out that Hill’s food safety plan acknowledged that elevated or insufficient levels of nutrients could cause a safety hazard to the animals and indicated that it would assess hazardous risks such as this before the ingredients entered the manufacturing facility. The FDA alleges Hill’s failed to follow through with these statements from its food safety plan.
The agency wrote in its warning letter to Hill’s, “… your firm did not obtain Certificates of Analysis (COA) upon receipt… of vitamin premix from your supplier. Your firm also failed to test, evaluate against your specification, and subsequently reject the vitamin premix containing excess vitamin D, as required by your food safety plan.”
Hill’s was issued a Form 483 for inspectional observations from the FDA following its inspection on Feb. 19, to which the pet food company responded on March 12, May 23 and Aug. 30, 2019. Hill’s issued a sweeping recall of 54 lots of 25 of its products on Jan. 31, 2019, then added 31 lots to the recall on March 20. Several class action lawsuits were made against the company regarding this recall, which involved approximately 675,000 cases of canned dog foods.
The FDA went on to say the agency is “unable to assess the adequacy of [Hill’s] corrective actions because many are preexisting procedures that were not followed consistently prior to the recall event.”
Hill’s told the FDA it would make corrective actions such as implementing COA requirements for its premixes, revising its receiving procedure, training employees on the new receiving procedure, integrating COA requirements into an internal system to prevent unchecked ingredients from slipping through the cracks, revising its food safety plan and implementing preventive control processes.
The FDA reiterated Hill’s responsibility to “ensure your firm complies with all requirements of federal law, including FDA regulations” and to “take prompt action to correct the violation.” Hill’s will be subject to a reinspection.
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