On August 16, 2018, DSM Nutritional Products, Inc. in Fort Worth, Texas manufactured two production lots of vitamin premix intended for use in dog food.
Due to a manufacturing error, the premix contained vitamin D at 2900% over the target concentration level.
The two batches of premix, comprising a total of 2.7 tons of material, were destined for a single customer – Hill’s Pet Nutrition Inc. in Topeka, Kansas.
The vitamin premix was used over a period of several months to manufacture 86 total lots of 33 varieties of canned, wet dog foods, under the Hill’s Prescription Diet and Hill’s Science Diet brands.
Those 86 lots, which were distributed across the United States and to 65 other countries around the world, contained toxic levels of Vitamin D.
Hill’s recalled the affected products in three separate announcements, the first in January 2019, the second in March 2019 and the third in May 2019.
In February 2019, Hill’s acknowledged to FDA inspectors that the company had received 85 consumer complaints reporting pet deaths associated with their dog food.
Those 86 lots were most probably responsible for hundreds of pet deaths and even more pet illnesses, causing pet owners unimaginable heartache and costing many thousands of dollars in veterinary bills.
DSM COULD HAVE PREVENTED THIS TRAGEDY
Had DSM carried out its responsibilities under the Food, Drugs & Cosmetics Act to evaluate foreseeable hazards and to implement preventive controls, the company would not have produced or supplied the faulty premix.
The Inspection Observations report, issued upon completion of FDA’s inspection in February 2019 and obtained by eFoodAlert in response to a Freedom of Information Act request, identified two deficiencies, quoted in full.
You did not evaluate each known hazard or reasonably foreseeable hazard for each type of animal food you manufacture, process, pack, or hold in your facility.
Specifically, your Hazard Analysis indicates the likelihood of using excessive Vitamin d in your premix (intended for use in dog food) to have a probability of occurring once in [REDACTED]. Your estimate is too low because your firm produced a super-potent premix on 8/16/2018 containing Vitamin D at a 30-fold excess that resulted in a Class I product recall on 1/31/2019.
You did not identify or implement preventive controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented.
Specifically, Vitamin D is an ingredient used in your premixes intended for use in dog food. You made two batches of the premix on 8/16/2018 (total of [REDACTED lbs) that proved to contain Vitamin D at 2900% concentration over the target level. These batches were shipped from your facility in Fort Worth, TX to your customer in [REDACTED]. A preventive control such as reconciliation of Vitamin D usage at a specified frequency could have prevented the contamination of these batches. (emphasis added)
HILL’S IGNORED ITS OWN SAFETY PLAN
If Hill’s had carried out the preventive controls specified in its own food safety plan, the company would have detected the toxic level of vitamin D present in the DSM premix batches.
As previously reported by eFoodAlert, Hill’s own written procedures called for vitamin D testing of the premix. However the company was unable to provide any evidence to FDA inspectors that those tests had been carried out.
Hill’s did not verify vitamin D levels either the premix or in their finished product until after receiving a consumer complaint on December 28, 2018.
THE BOTTOM LINE
The story is not yet done.
The race is not yet run.
The lawsuits have just begun.