At the 55th Session of the Codex Committee on Food Hygiene (CCFH), prompted by the ongoing infant botulism outbreak linked to ByHeart formula in the U.S., CCFH decided to initiate work related to the control of Clostridium botulinum in powdered infant formula.
U.S. Senator Bill Cassidy, Chair of the HELP Committee, has written a letter to ByHeart Inc., the infant formula manufacturer linked to an ongoing botulism outbreak, demanding answers about the conditions that led to the sale of unsafe product.
In this year-end episode of Food Safety Matters, we round up the top stories of 2025, covering U.S. federal food safety policy changes under the Trump Administration, MAHA- and state-led moves against food additives of concern and ultra-processed foods, infant formula safety, science on Listeria and biofilms, ongoing monitoring of avian flu, and AI food safety applications.
Considering the infant botulism outbreak linked to ByHeart Whole Nutrition Infant Formula, during which product was found on store shelves weeks after the recall was announced, FDA issued a letter to industry describing firms’ legal obligations in the case of a recall, as well as warning letters to four major retailers (Walmart, Target, Kroger, and Albertsons).
As of December 10, a total of 51 infants are included in the ByHeart formula botulism outbreak. With an expanded case definition, CDC has identified cases that occurred as early as December 2023.
The nationwide infant botulism outbreak associated with ByHeart infant formula has grown to 39 cases in 18 states. All 39 infants were hospitalized; no deaths have been reported.
ByHeart Inc. tested its products and found C. botulinum Type A in five of 36 samples across three lots. As of November 26, the outbreak includes 37 cases of infant botulism spanning 17 states. FDA has published inspection documents for ByHeart production facilities confirming a history of food safety issues.
Although the official number of infant botulism cases included in the ByHeart infant formula outbreak remains at 31, the unusual spike in infant botulism treatments recorded by the California Department of Public Health has grown to more than 100, and several babies with exposure to ByHeart formula were treated for botulism as early as November 2024, months ahead of the spike in illnesses.
As of November 19, the number of infant botulism cases linked to consumption of ByHeart formula has grown to 31 across 15 states. ByHeart's testing of its own product has confirmed the presence of Clostridium botulinum.
Clostridium botulinum-contaminatedByHeart-brand formula has sickened at least 23 babies across 13 states. FDA inspection reports and warning letters have come to light showing a history of food safety and hygiene violations at the company’s production facilities.
