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Home » Topics » Regulatory

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ByHeart Formula Now Linked to 23 Infant Botulism Cases in 13 States

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Bailee Henderson
November 14, 2025

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.


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A History of Food Safety Failures at ByHeart, the Formula Company Behind Infant Botulism Outbreak

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Bailee Henderson
November 14, 2025

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.


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Codex Commission Adopts New International Food Standards at 48th Session

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Food Safety Magazine Editorial Team
November 13, 2025

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.


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Shutdown Deal Restricts Funds for FSMA 204, Produce Safety Rule Enforcement

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Bailee Henderson
November 13, 2025

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.



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BIZTRACKS

ReposiTrak to Host Traceability Webinar for Seafood Suppliers

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Food Safety Magazine Editorial Team
November 12, 2025

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.


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Regan-Udall Report Supports FDA Infant Formula Safety Efforts

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Food Safety Magazine Editorial Team
November 11, 2025

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.


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newborn earing from bottle

Infants Nationwide Hospitalized With Botulism After Consuming ByHeart Formula

Bailee Henderson headshot
Bailee Henderson
November 11, 2025

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. 


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Food Safety Matters Podcast

Ep. 205. Black and Gabor: Digital Transformation and Emerging International Standards for Food Safety

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Food Safety Magazine Editorial Team
November 11, 2025

In this episode of Food Safety Matters, we speak with Mr. Tom Black, representing Codex Alimentarius and the Australian Government, and Dr. Gabor Molnar, representing UNIDO, about international food safety standards and trends in an increasingly digitalized and AI-driven world, as well as the work efforts of their organizations.


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Researchers Suggest Limited Effectiveness of Increased Controls on Food Imports at EU Borders

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Food Safety Magazine Editorial Team
November 10, 2025

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.


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TRACES Report Highlights Reasons for EU Food Import Rejections in 2024

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Food Safety Magazine Editorial Team
November 7, 2025

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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