ByHeart Update: FDA Confirms Review of ByHeart's Root Cause Investigation and Action Plan, Following Completion of Facility Inspections

• FDA found no factors that could explain the cause of the outbreak in ByHeart facilities
• FDA responded with no further questions on ByHeart's investigation and Action Plan
• ByHeart introduces new C. botulinum testing protocols 1000x more sensitive than the standard industry test methodology

NEW YORK, Aug. 28, 2026 /PRNewswire/ -- ByHeart today published an update on the company's ongoing response to the November 2025 infant botulism outbreak and its work toward a responsible return to infant formula production.

ByHeart provided the U.S. Food and Drug Administration with an approximately 400-page comprehensive submission detailing the company's root cause investigation findings, assessments conducted by independent food safety experts, complete action plan, new Clostridium botulinum testing protocols, and proposed corrective actions and preventive controls across its supply chain and manufacturing operations. Additionally, FDA and ByHeart agreed on reviewing pending materials on ByHeart's proposed use of a new sporicidal treatment method for facility surfaces and a new whole milk ingredient supplier.

FDA informed ByHeart in writing that outside of the pending items above, it has no further questions regarding the materials submitted.

This represents an important milestone in ByHeart's path forward. It follows FDA's June 3 public update confirming that the agency had completed its on-site inspections of ByHeart's manufacturing facilities. These inspections led to the identification of Clostridium botulinum in a powdered whole milk ingredient sourced from a third-party ingredient supplier. FDA stated that ByHeart facility inspections "did not identify any additional factors within ByHeart's facilities that could explain the cause of this outbreak." The agency also said that its broader root cause investigation remains ongoing, now with a focus on ingredients.

"FDA's review is an important milestone, but it is not the end of our work," said Ron Belldegrun, CEO and Co-Founder of ByHeart. "We are deeply committed to advancing the science of safety, and continuing to share everything we have learned with our community and with the industry. Our published research, as well as presentations at forums like the recent annual meeting of the International Association for Food Protection and C. botulinum-specific industry forums, reflect our commitment to transparency and collaboration to build a safer future for infant formula."

Strengthening Safety From Ingredient to Finished Product

ByHeart's submission brought together the findings of the company's investigation and the work of independent experts. The document highlighted outputs of ByHeart's work with IEH Laboratories, including new research published in Frontiers in Microbiology, and the development of the Advanced C. botulinum Safety Protocol. It also detailed actions which ByHeart has consulted with experts to design in order to strengthen safety throughout the full production system, including:

• New testing protocols specifically designed to detect C. botulinum in dairy ingredients and finished infant formula that achieves detection down to 0.01 CFU/g – 1000x more sensitive that the detection limit of SRC direct plating, the standard industry test methodology;
• Enhanced supplier qualification, verification and ingredient-testing requirements;
• Additional preventive controls across sourcing, manufacturing, sanitation and product release; and
• Continued independent scientific and food safety collaboration.

Remaining Steps on the Path to Market

Ahead of restarting infant formula production, ByHeart will provide FDA with 28 days advance notice and complete the required verification activities and pre-production commitments. ByHeart will continue to share additional information as this work advances.

About ByHeart

ByHeart is an infant nutrition company founded with the mission of building a future in which every parent can feel confident about how they feed their baby. The company is committed to advancing infant nutrition through rigorous science, responsible manufacturing and continued collaboration with regulators, researchers and food safety experts.

[email protected]

SOURCE ByHeart