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Home » Topics » Regulatory » FDA

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baby eating bottle

39 Infant Botulism Cases Now Linked to ByHeart Formula Outbreak

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Bailee Henderson
December 3, 2025

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.


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FDA Rolls Out Agentic AI for Staffers

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Food Safety Magazine Editorial Team
December 3, 2025

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.


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meat for sale

FDA Grants $1M to University of Illinois Researchers for Retail Meat AMR Surveillance

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Food Safety Magazine Editorial Team
December 3, 2025

The sampling and testing project will support the National Antimicrobial Resistance Monitoring System (NARMS) by identifying trends and emerging risks from drug-resistant foodborne bacteria. Findings will be used to create a model that can help predict and address antimicrobial resistance (AMR) mitigation strategies.


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FDA Petitioned to Ban PVC Gloves for Food Handling Due to Inadequate Food Safety

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Bailee Henderson
November 21, 2025

Glove manufacturer Eagle Protect PBC has submitted a petition to FDA urging the agency to prohibit the use of polyvinyl chloride (PVC or vinyl) disposable gloves for food handling in the U.S., citing compliance gaps, poor durability, and chemical risks.


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eggs

Salmonella Outbreak Linked to Eggs Ends With 105 Illnesses in 14 States

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Food Safety Magazine Editorial Team
November 20, 2025

A multistate salmonellosis outbreak linked to eggs produced by California-based Country Eggs LLC has ended with 105 illnesses, 19 hospitalizations, and no deaths reported. 


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baby eating bottle

ByHeart Outbreak Grows: 31 Infants in 15 States Hospitalized for Botulism From Tainted Formula

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Food Safety Magazine Editorial Team
November 19, 2025

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.


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ultra-processed foods (UPFs)

Food Safety Five Ep. 20: The Latest Research on Listeria Biofilms, E. coli, and the UPFs Debate

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Bailee Henderson
November 18, 2025

This episode of Food Safety Five discusses research on Listeria biofilms, including sanitizer efficacy and evolutionary insights, and on a persisting Escherichia coli strain in leafy greens. It also covers regulatory developments in the UK, Canada, and the UAE, as well as a potential U.S. ultra-processed foods (UPFs) definition.


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sandwiches

FDA Warning Letter Provides Insight Into Fresh and Ready Foods RTE Listeria Outbreak

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Food Safety Magazine Editorial Team
November 17, 2025

FDA recently released a warning letter dated September 5, 2025, issued to Fresh and Ready Foods LLC, a ready-to-eat (RTE) foods producer that was implicated in a multi-state, multi-year listeriosis outbreak.


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baby bottle

Congresswoman Presses FDA to Release ByHeart Inspection Records Amid Infant Botulism Outbreak

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Food Safety Magazine Editorial Team
November 17, 2025

Clostridium botulinum-contaminated ByHeart-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.


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Federal Workforce Data Reveal Impact of Trump Admin RIFs on USDA Food Safety Expertise

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Bailee Henderson
November 17, 2025

A new analysis of U.S. Office of Personnel Management (OPM) data conducted by the National Sustainable Agriculture Coalition (NSAC) quantified the impact of federal workforce cuts on experts and inspectors within USDA-FSIS and USDA-APHIS.


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