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FDA to Begin Testing Infant Formula Products, Ingredients for C. botulinum

infant formula and bottle — Image credit: RapidEye/E+ via Getty Images

In an interview with Bloomberg, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Human Foods Kyle Diamantas, J.D. revealed the agency’s intent to begin testing infant formula, as well as ingredients like milk powder and whey protein concentrate, for Clostridium botulinum.

C. botulinum is a foodborne pathogen that produces botulinum toxin, the cause of botulism.

Mr. Diamantas said the testing will inform whether C. botulinum contamination is a “foreseeable hazard that companies could test for.”

Announcement Follows ByHeart Botulism Outbreak

FDA’s announcement follows a national infant botulism outbreak linked to ByHeart infant formula products, which has been linked to 51 cases in 19 states. All infants were hospitalized. No new illnesses have been announced since December.

FDA testing has found C. botulinum toxin Type A in two samples of ByHeart powdered infant formula. Whole genome sequencing (WGS) showed the C. botulinum in the formula products to match isolates from samples of an organic whole milk powder used as an ingredient in ByHeart formula.

The cases linked to ByHeart are also part of a broader national spike of infant botulism cases, including more than 100 reports since late 2024.

FDA is not the only organization prompted to act by the ByHeart outbreak. In December, the Codex Committee on Food Hygiene (CCFH) also decided to initiate work related to the control of Clostridium botulinum in powdered infant formula. The Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) have issued a call for experts and data on microbiological risk assessment for powdered formula for infants and young children, with the ultimate goal of updating Codex Alimentarius standards.

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Bailee Henderson is the Director of Content Strategy for Food Safety Magazine. In the day-to-day, she covers industry-relevant current events, regulatory affairs, and scientific developments. She also produces the Food Safety Five Newsreel, edits the twice-weekly Food Safety Digest newsletter, and manages the brand's social media channels. Notably, Bailee's coverage for Food Safety Magazine has been featured in national televised news segments including CBS Sunday Morning and MSNBC's Rachel Maddow Show. She can be reached at hendersonb@bnpmedia.com.