– OPINION –
Is the safety of dog food as important as the safety of infant formula? That is the question facing officials at the Food and Drug Administration, but they aren’t talking about it much.
In recent days the FDA and the Department of Justice announced that Bravo Packing Inc., an animal food manufacturing company in Carney’s Point, NJ, is under a permanent injunction to stop selling, manufacturing and distributing raw pet food. An agreement in the form of a consent decree stipulates that the dog food company will come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The two federal departments tooted their horns, saying that the action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice (CGMP) requirements of the Food Safety Modernization Act (FSMA ) Preventive Controls for Animal Food Regulation.
Part 507 requires, among other things, that animal food facilities take adequate precautions to prevent animal food from becoming contaminated and that all animal food manufacturing, processing, packing, and holding must be conducted under the conditions necessary to minimize the potential for the growth of undesirable microorganisms to protect against the contamination of animal food.
Sounds pretty good to me, being that I am an animal lover and have lived with a dog or cat my entire life — except when I was in college.
But, even though I am not a parent, it seems to me that an infant formula plant ought to be as important as a pet food plant when it comes to enforcement of measures in the Food Safety Modernization Act of 2011 and the Federal Food, Drug and Cosmetic Act.
I don’t want to mislead our readers. The FDA and DOJ have exercised their joint power to impose permanent injunctions against food companies. The actions generally come after years of investigation and opportunities for the companies to come into compliance, however.
The delay in shutting down operations at the Abbott Nutrition baby food factory in Sturgis, MI, — if it ever happens — will also likely take a long time. The plant has been linked to an outbreak of Cronobacter infections that has hospitalized four infants. Two deaths are under investigation, though I don’t see how much investigation there is to do considering the two dead babies were fed infant formula from the implicated plant and developed Cronobacter infections.
The bullet points on the outbreak are:
- Four infants with Cronobacter infections in Minnesota (1), Ohio (2), and Texas (1) consumed formula produced at the Sturgis, MI, facility before they got sick.
- Formula types recalled in relation to the outbreak are Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40.
The FDA is continuing to investigate the situation, though their work is increasingly seeming like too little too late.
In September 2021 public health officials in Michigan notified the FDA that there was a case of Cronobacter infection in a baby who had been fed infant formula from the Sturgis, MI, plant. Reports of two other cases were sent to the FDA later in 2021, followed by another one early this year.
During inspections at the plant this year the FDA found Cronobacter contamination as well as discovered company documents that showed such contamination in the facility dated back at least as far as 2018.
Officials with Abbott Nutrition have said that they tested samples of the formula involved in the outbreak before it left the factory but those tests came back negative. The company also has stated that the manufacturing plant will remain closed for a while.
A company spokesperson had this to say when I specifically asked how long the plant will be closed and what criteria will be used to determine it is safe to resume operations:
“I don’t have specific answers to your questions, but we address the situation in our statement. Here’s a relevant section: We have already begun implementing corrective actions and enhancements at the facility, leveraging new technology and strengthening our processes, to give parents and customers renewed confidence in the quality of manufacturing at our Sturgis plant when we restart operations there.”
A spokesperson from the FDA confirmed that the manufacturing plant is currently closed, but referred me to the company for details about when it will reopen.
It is time for the FDA and DOJ to fast-track action to seek a permanent injunction against Abbott Nutrition in relation to the outbreak.
Babies are at least as important as dogs.
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