While the FDA’s investigation is ongoing, the latest updates about the whole milk powder that we source suggests that we are significantly closer to determining the root cause of the contamination of ByHeart formula.

FDA has shared their lab analysis and found genetic matches involving two positive samples of C. botulinum Type A collected by FDA: the first is a sample of ByHeart infant formula, and the second is a new sample of whole milk powder, collected by FDA from a supplier to ByHeart. 

These findings from FDA are consistent with the whole genome sequencing (WGS) analysis conducted by ByHeart at IEH Laboratories. These WGS sequences represent a second concrete genetic match between the whole milk powder ingredient, finished ByHeart formula, and a clinical sample from a child with Infant Botulism from this outbreak. 

Our investigation has included a detailed examination of our facilities, processes and supply chain – from farm-level ingredients, to every piece of equipment at our owned facilities, through to the final finished product. 

The investigation remains underway and we will provide new information as we learn more.

We remain committed to finding the facts and evidence about what led to the contamination of ByHeart products. We continue to work in cooperation with FDA to share new results from our ongoing investigation, which has included a detailed months-long examination of our facilities, processes and supply chain – from farm-level ingredients, to every step and piece of equipment of our owned manufacturing process, through to the final finished product.

ByHeart continues to test ingredients. We will provide updates on the conclusion of the investigation when we learn more.

At this time, testing for C. botulinum is not the industry standard. Instead, the industry (including regulators) relies on preventive controls, validated processing steps, and indicator tests, like SRC, to ensure stricter supplier selection and qualification. 

We are working with our lab testing partner at IEH on new testing protocols for C. botulinum from farms, to supplier facilities, to our factories. Even though testing on the whole milk powder we received from suppliers exceeded industry and regulatory standards, we now know that the existing safeguards are insufficient. This outbreak revealed that this pathogen can make its way into the infant formula supply chain. Going forward, we are committing to instituting new testing protocols and conducting third-party testing for C. botulinum on every batch of our finished infant formula and throughout our supply chain.

To complement this enhanced testing, we are evaluating a comprehensive set of additional preventative controls throughout our supply chain and manufacturing process to further safeguard risk posed by C. botulinum or other spore-forming bacteria. We will share further details as these are finalized.

All ByHeart suppliers must meet rigorous approval criteria designed to ensure the highest standards of safety, quality, compliance, and transparency. 

The process begins with supplier pre-screenings, including evaluation of the company’s relevant certifications (such as SQF, BRCGS, or ISO), regulatory compliance, and alignment with ByHeart’s strict quality and food safety standards.

Qualified suppliers then undergo a comprehensive audit, including but not limited to a detailed review of pre-requisite programs, standard operating procedures, food safety and allergen control plans, environmental monitoring programs, heavy metal and contaminant testing policies, and  detailed product specifications and certificates of analysis covering origin, analytical testing, and microbiological testing. 

Suppliers are also assessed on sustainability and traceability practices, including ESG programs, and are classified through a detailed risk assessment. 

ByHeart also conducts regular onsite or virtual audits to verify program execution, identify gaps requiring corrective actions and to ensure continued adherence to ByHeart’s stringent requirements.

ByHeart has extensive supplier specification in place covering milk products. This includes more stringent specifications that cover pathogens (B. cereus, Staphylococcus, E. coli and Salmonella), spores (total spore count & SRC), and hygiene indicators (Enterobacteriaceae and coliforms). 

ByHeart also qualified for the Clean Label Project’s First 1,000 Day Promise Certification, meeting the most strict compliance requirements, inclusive of rigorous testing for pesticide, glyphosate, heavy metal, plasticizers, and prohibited ingredients. 

We hold our ingredients to stringent limits for each specification.

ByHeart ensures ingredients are not contaminated after arrival through multi-layered controls designed specifically for infant safety. 

Upon arrival at our production sites, shipments undergo strict security checks and anything of concern is immediately quarantined. 

Ingredients remain on hold while documentation, such as Certificates of Analysis, lot codes, and specifications, are verified, packaging and labeling are inspected, and third-party laboratory testing is completed for identity, nutrients, and microbiological safety. 

Once reviewed and approved by our Quality team, ingredients are stored under controlled environmental conditions, and they are further protected by validated sanitation programs, environmental monitoring, foreign material controls, and full lot-level traceability throughout manufacturing and packaging.

Yes. ByHeart maintains a robust Supplier Approval Program (SAP) aligned with FDA requirements and industry best practices.

The Supplier Approval Program is a process used to assess, approve, and continually monitor their ingredient, packaging, and service suppliers to ensure they meet safety, quality, and regulatory requirements. 

This ensures all suppliers providing goods or services meet both regulatory standards and ByHeart’s standards for quality, safety, compliance, reliability, consistency and ethical practices before entering into or continuing a business relationship. 

This framework is designed to mitigate risk, protect consumers, and support consistent operational excellence.

Based on the root cause investigation, our immediate focus is on creating and implementing enhanced testing and comprehensive preventative controls throughout our supply chain and manufacturing process to further safeguard risk posed by C.botulinium or other spore-forming bacteria.

Even though testing on the organic grass-fed whole milk powder we received from suppliers exceeded industry and regulatory standards, we now know that the existing safeguards are insufficient. This outbreak revealed that this pathogen can make its way into the infant formula supply chain. Going forward, we are committing to instituting new testing protocols and conducting third-party testing for C. botulinum on every batch of our finished infant formula and throughout our supply chain.

To complement this enhanced testing, we are developing a comprehensive set of additional preventative controls throughout our supply chain and manufacturing process to further safeguard risk posed by C.botulinium or other spore-forming bacteria. We will share further details as these are finalized.

At this time, we are not naming specific suppliers we work with. We do not have visibility into who else they may be working with outside of ByHeart.