US Will Test Infant Formula to See If Botulism Is Wider Risk

U.S. health officials plan to test certain dairy-based ingredients used in a wide variety of baby formulas for spores that can cause infant botulism, in the wake of the ByHeart recall last year that was connected to 51 infant hospitalizations.

The Food and Drug Administration will test ingredients such as 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,” Kyle Diamantas, deputy commissioner for human foods at the agency, said in an interview with Bloomberg.

As part of the ByHeart investigation, testing recently identified spores that can cause infant botulism in a whole milk powder at a company that supplied ingredients to the startup. Infant formula makers have not had to test for the spores because they haven’t been previously known to contaminate the products.

“Currently we have no reason to believe the infant formula supply in the U.S. is unsafe,” Diamantas said.

The ingredient testing is an effort to “evaluate the whole supply chain and understand our next steps,” he said.

Asked whether companies could be required in the future to test for Clostridium botulinum spores, Diamantas said it is a “real possibility.” It’s unclear whether something has changed in infant formula production or whether potential contamination caused by the bacteria was missed in years past, he added. The agency hopes to find out.

ByHeart has paused infant formula production and said in a statement it would take steps to resume manufacturing after the FDA completes its investigation into the outbreak. The agency hasn’t yet released the results of its inspections of ByHeart’s factories.

When asked if ByHeart would be able to resume production, Diamantas said, “I’m not sure.”

Top photo: A bottle of milk prepared from infant formula sits on a table Beijing, China, on Saturday, Jan. 12, 2019. Photographer: Giulia Marchi/Bloomberg.