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 48th session of the Codex Alimentarius Commission (CAC48) has adopted and revised various standards, including new maximum levels for lead in cinnamon and dried herbs, the first international standard for fresh dates, updated food additives provisions, and other standards.
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.
Researchers have developed a new, farm-to-fork quantitative microbial risk assessment (QMRA) model to evaluate the risk of Listeria monocytogenes contamination in fresh-cut cantaloupe.
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.
A new study underscores that the level of consumer protection afforded by the food import control measures established in Commission Implementing Regulation (EU) 2019/1793 may not be proportionate to the resources invested.
The Trade Control and Expert System (TRACES) is the EU’s digital platform for managing sanitary, phytosanitary, and food safety certification to support the trade of regulated products.
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