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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).

This article provides background information about FDA’s CORE+EP Signals team's day-to-day work in detecting foodborne illness outbreaks and triaging incidents, and highlights some real-world examples and partnerships that have occurred to improve food safety and protect consumers.

The third installment of the second FDA-Stop Foodborne Illness Food Safety Culture Webinar Series, titled, “Measure the Power of Declared Values,” will be held on December 17.

The Federal Food Administration Act would create an entirely original, independent federal food agency, moving responsibility for oversight of the nation’s food supply from FDA to a new Federal Food Administration.

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 newly published 2024 FDA Food Code Adoption Report outlines Food Code adoption status in U.S. states, territories, and tribes.

The Safe Food Coalition, comprising seven influential stakeholder groups, has written a letter to FDA, CDC, and Health Secretary Robert F. Kennedy Jr. urging the agencies to take immediate action to protect infant formula, in light of the ongoing ByHeart infant botulism outbreak.

In this episode of Food Safety Matters, we speak to legal expert Brian P. Sylvester, J.D. about the rapidly evolving U.S. food regulatory landscape under the MAHA movement, and how food companies can prepare for state and federal policy changes regarding food dyes, GRAS ingredients, ultra-processed foods, and other areas.

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.

The artificial intelligence (AI) rollout is intended to improve operational efficiency by enabling the creation of more complex AI workflows to assist with multi-step tasks, including pre-market reviews, review validation, post-market surveillance, and inspections and compliance.