The FDA has reviewed our investigation findings, corrective actions, new testing protocols, and proposed preventative controls and confirmed it has no further questions. This follows the agency’s update on June 3 stating it had concluded ByHeart’s facility inspections and did not identify any deficiencies in our manufacturing facilities that could explain the root cause of this outbreak. There are remaining steps we are working through with the FDA before production resumes, and we will share updates as we complete them.

New research conducted by ByHeart and IEH Laboratories, published in Frontiers in Microbiology, revealed that C. botulinum can be present at levels low enough to go undetected by the industry's standard screening method (SRC), but high enough to make babies sick. Working with IEH Laboratories, we developed the Advanced C. botulinum Safety Protocol – a purpose-built, dual-method test applied at three stages of production, and capable of detecting contamination 1,000x below the SRC detection limit by traditional direct plating methodology. We are sharing both the research and the protocol openly.

Since the start of the recall, we have cooperated closely with the FDA on a thorough root cause investigation into the Clostridium botulinum outbreak. Based on pivotal insights from the investigation, ByHeart's Action Plan outlines the steps we are taking to prevent this from happening again – covering new C. botulinum-specific testing protocols, enhanced supplier and ingredient quality assurance, manufacturing and facility improvements, and the establishment of an independent Food Safety Advisory Council. We are working toward the safe resumption of infant formula production, in close cooperation with the FDA. 

FDA announced it has completed onsite inspections of ByHeart's facilities and it did not identify any deficiencies that could explain the root cause of this outbreak. The agency confirmed it is continuing to investigate the powdered milk ingredient produced by a third-party supplier where Clostridium botulinum was identified. FDA is working with ByHeart to safely resume infant formula production. As part of our Action Plan, a new C. botulinum-specific testing protocol will be applied to every dairy ingredient and finished batches before release.

CDC and FDA announced that the infant botulism outbreak had ended, with no new cases reported since December. FDA also confirmed that whole genome sequencing identified a match between two additional samples from a supplier lot of Organic Whole Milk Powder, a previously identified ByHeart formula sample, and a clinical sample from a child with infant botulism. FDA’s investigation into the root cause continues, and so does our work to learn from this outbreak. 

As ongoing testing produced new results, ByHeart submitted raw C. botulinum genetic data from both finished product and ingredient samples to the NIH's National Center for Biotechnology Information (NCBI), a public federal database where food safety researchers and public health scientists can access what we found. This investigation generated a substantial body of data, and it is important to us that it is accessible to those working to advance the science around C. botulinum.

FDA shared a significant finding: genetic matches between two positive samples of C. botulinum Type A – one from ByHeart infant formula, and one from a sample of Organic Whole Milk Powder collected by FDA from our suppliers. This was a meaningful step forward. While the investigation was not yet complete, the evidence was continuing to point toward the ingredient supply chain.

FDA and CDC identified additional infant botulism cases linked to the outbreak. 

IEH Laboratories, our independent food safety partner, also confirmed the presence of C. botulinum, the bacteria that causes infant botulism, in six of 36 finished product samples across two recalled batches. Whole genome sequencing, a highly precise genetic matching technique, conducted by IEH confirmed those results conclusively. The data was beginning to point us toward a source.

ByHeart’s testing confirmed the presence of C. botulinum in unopened cans of ByHeart formula. This was a critical and sobering finding. It told us the contamination had occurred before the product reached families. This helped inform the investigation and deepened our resolve to find the source.

When the FDA notified us of a potential link between our formula and cases of infant botulism on November 7, we issued a voluntary recall of two batches within 24 hours and treated this with the urgency it demanded of us. Our team and resources were immediately directed to investigating what happened, working in full coordination with the FDA and regulators.

As the investigation developed quickly, we expanded that recall to include all ByHeart products and paused all production – notifying retailers and stakeholders in lockstep with regulatory guidance. Families who had trusted us, many of whom had chosen ByHeart because of our safety standards, were understandably upset. Getting answers was challenging, and some of our early communications made a frightening situation worse instead of better. This didn’t reflect our values of providing the care and clarity that families deserve and we resolved to make meaningful efforts in transparency as the investigation continued.