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FDA to Test Dairy Ingredients for Infant Botulism Spores
4 Feb
Summary
- US officials will test dairy ingredients for infant botulism spores.
- Testing follows last year's ByHeart recall linked to infant hospitalizations.
- New testing aims to assess supply chain risks and future company requirements.
US health officials are set to test certain dairy-based ingredients, including milk powder and whey protein concentrate, for spores that can lead to infant botulism. This proactive measure comes after a recall by ByHeart last year, which was associated with 51 infant hospitalizations.
The Food and Drug Administration's initiative seeks to understand potential contamination risks within the supply chain. Officials are evaluating whether the presence of these spores constitutes a foreseeable hazard that manufacturers should actively test for.
Currently, there is no indication that the U.S. infant formula supply is unsafe. However, this ingredient testing is a crucial step to assess the overall supply chain and inform future regulatory actions. The agency is considering mandating spore testing for infant formula makers, a possibility that has not been a requirement previously.
ByHeart has temporarily halted production and is awaiting the FDA's investigation results before resuming operations. The timeline for ByHeart's return to production remains uncertain as the FDA continues its inspections and analysis.
