To the ByHeart community,

Since November 7, we have been cooperating closely with the Food and Drug Administration (FDA) and other agencies, and collaborating with respected third-party laboratories and experts on a comprehensive root cause investigation into the presence of Clostridium botulinum in ByHeart infant formula products.

Today, 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. While the FDA’s investigation is ongoing, these new findings 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.

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

ByHeart’s team includes IEH, which conducted all testing and generated the key WGS data; Dr. Kathleen Glass, a global subject matter expert specifically in C. botulinum; and an advisory group of former FDA and CDC officials, along with other C. botulinum professionals. Our ongoing investigation 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.

We take our responsibility to ByHeart families incredibly seriously, and we are deeply sorry for the impact this outbreak has had on our community. While we await the conclusions of FDA’s root cause investigation, we are moving forward with that same sense of responsibility and taking action to regain your trust.

Next Steps

ByHeart has always stood for bringing meaningful, science-driven innovation and the highest levels of quality and safety to families. As we have gained unique insights through this investigation, we started to develop a set of actions to evolve our testing protocols and manufacturing process to ensure that an outbreak like this does not happen again.

• • Testing Protocols: We are working with our lab testing partner at IEH on new testing protocols for C. botulinum from farms 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.
    
    
  • Manufacturing Process & Controls: 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.
    
    
  • Expert Validation: We are creating a Food Safety Advisory Board of leading third-party experts to validate the actions we take, and identify future risks to continuously safeguard infant formula from spore-forming bacterium, heavy metals and other contaminants. We want to find the next thing, before it ever becomes the next thing, and to serve families with the safest batch of infant formula ever made, every time. And we’re committed to sharing what we learn publicly to help create a safer future for infant formula.

While there is much more to do, this is a significant development. We are grateful to IEH Laboratories, Dr. Kathleen Glass, and the full team of cross-functional experts for their relentless and continued focus on this critical issue.

From day one, our mission has been grounded in offering the best for infant health. That mission has not changed, and we will keep striving toward better quality, better safety, and better products. That’s what families deserve.

Ron & Mia