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The outbreak of infant botulism linked to ByHeart infant formula has grown to 23 confirmed cases in 13 states. All infants have been hospitalized, with no deaths reported. The company has issued a recall of all formula products sold nationwide.

ByHeart Inc., the infant formula manufacturer implicated in an ongoing, multistate botulism outbreak, has a history of food safety and hygiene violations at its production facilities, as well as an inadequate root cause analysis in previous incident, per FDA inspection records and warning letters.

The FY 2026 appropriations bill, approved by Senate to end the U.S. government shutdown, sets forth FDA’s Human Foods Program budget for FY 2026. It also prohibits the use of federal funds to enforce certain FSMA rules within designated timeframes or for specific commodities.

Taking place on November 18, the session will outline the traceability expectations of major retailers, wholesalers, and foodservice distributors, the implications for seafood suppliers, and how ReposiTrak can simplify end-to-end traceability—especially in light of FSMA 204.

The Reagan-Udall Foundation has published a report that captures key insights from stakeholder discussions on ways to improve U.S. infant formula safety and regulation, which were held to support FDA’s “Operation Stork Speed” efforts.

As of November 11, 15 infants have been hospitalized with botulism in 12 states after consuming ByHeart-brand powdered infant formula. The 15 infants who were confirmed to have consumed ByHeart are part of a broader outbreak comprising 84 total cases. A recall has been issued. 

Foreign food safety inspections conducted by FDA have hit a historic low due to Trump Administration budget and staff cuts, according to an investigative report by ProPublica.

A letter sent to FDA urges the agency to immediately withdraw its approval of Carbadox, a carcinogenic swine feed additive. FDA’s proposal to withdraw Carbadox approvals has been pending for two years, during which time there has not been an approved method for detecting Carbadox residue in pork. 

In this bonus episode of Food Safety Matters, we speak to Kris Sollid, RD of the International Food Information Council (IFIC) about IFIC’s recent consumer surveys measuring Americans' confidence in, and understanding of, the safety of the U.S. food supply, as well as how “MAHA” may be influencing consumer perceptions. 

Food industry representatives and consumer advocacy groups have shared their comments, which are varied in opinion, submitted in response to FDA and USDA’s joint request for information to support a federal definition for ultra-processed foods (UPFs).