A warning letter from the FDA to Hill's outlines the results of the agency's investigation, noting that the company's stated corrective actions may not solve the problem. Meanwhile, nearly 300 lawsuits have been combined.
chalabala / stock.adobe.comIn three separate announcements earlier this year, Hill's initiated recalls for a total of 86 lots including 33 varieties of its canned dog food products. (The complete list of recalled products can be found here.) The recalls were prompted by the finding of excessive, potentially toxic amounts of vitamin D in some Hill's pet foods.
FDA cites ‘systematic failure' in response letter
Following each of Hill's first two recalls, in January and March, the FDA inspected the company's Topeka, Kansas, manufacturing facility. Last week, the agency released a warning letter to Hill's outlining the results of its inspections and investigation, and discussing its view on the proposed corrective actions Hill's will take to avoid potential problems with its food ingredients in the future.
The FDA letter states that it has confirmed Hill's findings that “animal food products with unsafe levels of vitamin D were manufactured and marketed by your firm. 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.”
In fact, the vitamin D levels in the tested lots of recalled products were “in excess of 33 times the recommended safe upper limit.” Under the Federal Food, Drug, and Cosmetic Act, such immense levels of vitamin D render it an unsafe food additive, and dog foods containing this additive are considered adulterated.
The FDA concludes that it was Hill's failure to follow its own safeguards and procedures that led to the massive recall, calling it “a systematic failure of your food safety plan.”
The FDA states that it cannot assess Hill's corrective actions adequately because they don't “address the root cause of this incident,” and “many are preexisting procedures that were not followed consistently prior to the recall event.” In other words, Hill's food contained excessive amounts of vitamin D because the company didn't follow its own rules for ensuring food safety in the first place, so how can the FDA trust that Hill's will actually take the steps needed to prevent another catastrophic pet food recall?
Hill's has 15 business days (from Dec. 10) to send a response letter to the FDA noting specific steps it has taken to correct violations and prevent future infractions.
Meanwhile, the U.S. Judicial Panel on Multidistrict Litigation combined 35 lawsuits against Hill's into a single federal action. According to an article on petfoodindustry.com, the merged suit includes about 300 named plaintiffs from across the United States whose pets became ill or died after eating recalled Hill's products. In addition to emotional distress and financial loss, complaints made in the individual lawsuits claimed that Hill's:
Was aware of the contamination months before the company alerted the public
Made marketing claims and statements-one of which warns consumers about the risks of feeding pets excessive nutrients-that misrepresented its products
Delayed revealing the full scope of the problem and all contaminated products.
The consolidated lawsuit will be heard in Kansas City, Kansas, near Hill's headquarters and production facility.