The Path Forward: Our Commitment to Action
To our ByHeart families,
While the CDC and FDA announced that the infant botulism outbreak has ended, with no new cases reported since December, there’s still much more to do. We take our responsibility to ByHeart families incredibly seriously, and we are deeply sorry for the impact this outbreak has had on our community.
Nothing is more important to us than the health and safety of your little ones. 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 the investigation, we have developed a comprehensive action plan to strengthen our processes and reaffirm our commitment to safety and quality.
We are not waiting to act. While the broader root cause investigation remains ongoing, we have started to move ahead with a number of key actions outlined below to ensure that an outbreak like this does not happen again. In parallel, we have a dedicated team that continues to cooperate fully with the FDA in its investigation.
The actions outlined here will evolve as we learn more from the investigation and its findings, but we are committed to taking the steps below and sharing our progress. We have been working with experts, including IEH, Dr. Kathy Glass, and Eric Johnson to validate this approach. We have also shared this plan with the FDA, and as the investigation moves ahead, we will continue to coordinate further actions with them.
We have always been proud of our rigorous standards, and now we are making them even stronger. Here are the immediate steps we are taking:
Investigation
We remain committed to fully understanding the source and nature of the outbreak, so that we can offer the most robust safety measures possible.
Comprehensive Root Cause Investigation & Analysis
We have followed FDA’s Recall process, and have submitted our full comprehensive root cause analysis and corrective action plan, including assessments from independent third-party experts. Our teams will continue to support their investigation, and utilize our detailed understanding of this pathogen to offer the most robust safety measures possible.
Facility Review
Conducting comprehensive tests of our equipment and environment for the presence of C. botulinum and any other risk factor. We also supported FDA and other agencies on inspections of our Portland, OR and Allerton, IA facilities.
Testing & Verification
The seriousness of this outbreak demands the most innovative testing approach, that will add industry-first C. botulinum protocols to a robust foundation of testing protocols that already exceeded industry standards.
Develop & Implement New C. botulinum Testing Protocols
To ensure the highest level of safety, we've developed the Advanced C.Bot Safety Protocol, an industry-first testing method. By using multi-layered microbiological screening at three critical points in our production, we can more powerfully detect any risk of C. botulinum.
Third-Party Lab Testing
We have engaged the world-leading IEH Laboratories as the independent third-party lab to run the multi-stage testing on every batch at every stage.
Regularly Review & Enhance Comprehensive Ingredient Testing
Regularly review and enhance our comprehensive, multi-stage testing protocol to ensure any evolving threat is covered, inclusive of spore-forming pathogens (including C. botulinum, B.cereus), in addition to heavy metals, cronobacter, salmonella, and other contaminants.
QR-Enabled Product Traceability
Launch a new traceability process to give parents a third-party verified view of the testing results for their specific batch of formula. This will include C. botulinum, B. cereus, cronobacter, salmonella, heavy metals, etc.
Manufacturing & Quality
We are implementing further enhancements to our manufacturing and quality control protocols to ensure the highest level of safety at every step.
Install New Preventative Technology & Manufacturing Steps
We are committed to continued innovation in our facilities and entire manufacturing process, exploring the latest technology to enhance infant-grade safety. This includes installing new preventative technology in our process.
Relaunch Facility Sanitation
In addition to the regular facility sanitation procedures, we will perform a full sporicidal sanitation on our infant formula facilities, followed by verification of its effectiveness.
Enhanced Facility Safeguards
Develop and publish enhanced preventative facility measures and on-going external compliance audits. This includes regular sanitation breaks to control any potential contamination due to raw materials, and independent on site inspections to verify corrective actions and maintain the highest operating standards.
Maintaining our commitment to US and Manufacturing
ByHeart is incredibly proud of manufacturing our products in the U.S. As we explore new supplier partnerships that will provide the highest quality dairy ingredients, we remain committed to domestic production.
Supplier & Ingredient Quality Assurance
We are working closely with our partners to ensure our high standards are met throughout our entire supply chain.
Build Increased Roster of Ingredient Suppliers
Committing to continued innovation in our facilities and entire manufacturing process, exploring the latest technology to enhance infant-grade safety. Including installing new preventative technology in our facilities.
Expand Infant Formula-Grade Ingredient Specifications
Adding specifications and criteria, based on what we’ve learned, to our comprehensive ingredient selection and annual evaluation process with suppliers.This outbreak has proven that typical preventative and testing measures are no longer sufficient, and therefore suppliers and brands need enhanced systems to protect ingredients.
Enhanced Facility Safeguards
Develop and publish enhanced preventative facility measures and on-going external compliance audits. This includes regular sanitation breaks to control any potential contamination due to raw materials, and independent on site inspections to verify corrective actions and maintain the highest operating standards.
Maintaining our commitment to US and Manufacturing
ByHeart is incredibly proud of manufacturing our products in the U.S. As we explore new supplier partnerships that will provide the highest quality dairy ingredients, we remain committed to domestic production.
Support New Safety Measures at Dairy Farms
Working with suppliers and farm partners to develop robust new control processes, with a particular focus on the critical processes of gathering and processing whole milk.
Governance & Expert Oversight
To ensure accountability and access to leading expertise, we are enhancing our internal governance and creating a new external advisory council.
Safety Culture & Training
The Operations Training & Development Director will also expand our onboarding and training process, and our “Outside In” culture of bringing scientific, safety and regulatory expertise into our facilities to audit and advance our methods.
Expert Advisory Council
We are establishing an independent Food Safety Advisory Council, composed of leading experts in food safety, microbiology, and public health. The council will provide strategic guidance on our food safety programs and proactive identification of emerging risks, to help deliver the highest standards of quality and safety to families.
Food Safety Education
Support the development of food safety education from third-party experts and leaders to provide easy-to-understand evidence-based information for parents.
Our Ongoing Commitment to You
We understand that rebuilding trust will take time and consistent, transparent action. This action plan is an overview of our path forward. We are committed to providing you with regular updates on our progress across all of these categories. The trust of our ByHeart community is the foundation of everything we do and we want to show you, not just tell you, that we are doing everything in our power to move forward the right way.
Sincerely,
The ByHeart Team
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