There are plans for the FDA to next year begin testing some of the dairy ingredients in infant formula for botulism-causing spores, according to an agency official.
The move comes in the wake of an outbreak that sickened 51 babies. The botulism spores were found in samples of infant formula produced by ByHeart Inc. Recently it came to light that the companies that provided powdered milk to the company were the source of the pathogen.
Kyle Diamantas, deputy commissioner for human foods at the Food and Drug Administration told, Bloomberg news that the agency would begin testing products including milk powder and whey protein concentrate to help determine whether contamination that could lead to botulism is “a foreseeable hazard that companies could test for.”
Infant formula makers are not currently required to test for the spores because they haven’t been previously known to contaminate the products. Diamantas told Bloomberg that there is currently no reason to believe that the overall infant formula supply in the United States is unsafe.
He told the media outlet that it’s unclear whether something has changed in infant formula production or whether potential contamination caused by botulism spores was previously undetected.
The outbreak of infant botulism began in December 2023, but the vast majority of babies became ill beginning in August 2025. All of them required hospitalization, but none died.
ByHeart was founded and began producing infant formula after a 2021 outbreak of cronobacter infections, including infant deaths, caused a severe formula shortage.
The company has recalled all of its formula and has suspended operations pending the completion of the FDA’s investigation. The agency has not released the results of its inspections of ByHeart’s factories.
