Beltway Beat

FDA and CDC Leading Multistate Outbreak Investigation of Infant Botulism from Infant Formula

As of November 10, 2025, a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula. All 15 infants were hospitalized. No deaths have been reported to date. FDA’s Commissioner, Dr. Marty Makary, interviewed on CBS News on Nov.12, stated that the FDA did find one positive case of the bacteria that produce botulinum toxin in a can of ByHeart infant formula. Update: The New York Times reported that a Pennsylvania plant run by the company, ByHeart, was shut down this year after inspectors found mold, a leaking roof and more than 2,500 dead insects in a food production area. 

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Allergen Alley

FDA to Open Registration for the Virtual Public Meeting and Listening Sessions on Food Allergen Thresholds and Their Potential Applications

By Food Safety Tech Staff
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Recent scientific developments in food allergen thresholds have prompted the FDA to explore how these thresholds can improve food safety, enhance labeling practices and help consumers make more informed choices. The purpose of the public meeting and listening sessions is to discuss strategies for approaching food allergen thresholds to benefit public health.

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