Understanding Infant Formula Safety: ByHeart Supplier & Ingredient Testing

In conversation with ByHeart’s Dr. Niall Mullane and Dr. Devon Kuehn  

In the wake of the Clostridium botulinum outbreak connected to ByHeart formula and the voluntary recall of all products on November 11, 2025, parents want to understand how this happened, what infant formula safety systems are in place, and what changes are needed to safeguard against this toxin and other spore-forming bacteria in the future. To help make sense of and learn from this event, we’re sharing insights from subject matter experts [LINK to page] and other useful resources. We are using our learnings to evolve our testing protocols and manufacturing process to ensure that an outbreak like this does not happen again.

What Goes Into Infant Formula Safety Systems

Dr. Devon Kuehn: Infant formula is among the most tightly regulated food products in the United States, with federal regulators setting and enforcing rigorous safety and nutrition standards to ensure setting and enforcing rigorous safety and nutrition standards to ensure every product is safe and nutritionally complete for babies. Rather than relying solely on finished product testing, manufacturers are required to implement preventive safety systems designed to reduce risk throughout the supply chain. These systems include supplier audits, ingredient verification, sanitation controls, environmental monitoring, and traceability measures. The goal is to prevent contamination before it occurs, rather than attempting to test for every possible pathogen after production.

In the U.S., the Food and Drug Administration (FDA) is the government agency that sets and enforces safety and nutrition standards for infant formula. Because it’s a baby’s only source of nutrition, and critical for their development, infant formula has its own set of rules to make sure it’s safe and sufficient for growing infants. 

The FDA sets clear requirements for what nutrients must be included, how products are manufactured, and how facilities maintain safety and quality controls. Companies must also notify FDA before introducing a new formula or making significant changes to an existing one.

To make sure those standards are followed, FDA regularly inspects manufacturing facilities, reviews testing and quality records, and samples products. If something doesn’t meet safety requirements, the agency has the authority to request or require immediate actions from the company producing the formula. 

What Practices and Protocols Does ByHeart Have in Place for its Suppliers?

Dr. Niall Mullane: ByHeart has always stood for bringing meaningful, science-driven innovation and the highest levels of quality and safety to families. All ByHeart suppliers must meet rigorous criteria designed to ensure the highest standards of safety, quality, compliance, and transparency.

Our 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 (Environmental, Social and Governance) (Environmental, Social and Governance) programs that reflect an organization's social and environmental impact and ethical business and corporate practices that reflect an organization's social and environmental impact and ethical business and corporate practices, and are classified through a detailed risk assessment. ByHeart also conducts regular onsite or virtual audits to identify gaps requiring corrective actions and to ensure ongoing adherence to ByHeart’s stringent requirements.

What kind of controls does ByHeart have in its facilities to ensure ingredients are not contaminated?

Dr. Niall Mullane: ByHeart has measures to test its product throughout the entire production process. To start, we ensure ingredients are not contaminated after its arrival to our production sites 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.

[Niall – Does this capture it or anything else we should note re: steps and controls after it arrives, through to the finished product?] 

What testing did ByHeart have in place to test for or detect the C.botulinum toxin?

Dr. Niall Mullane: Specific testing for C. botulinum is not currently an industry standard for infant formula or dairy ingredients. Instead, the industry relies on preventive controls, validated processing steps, and indicator tests, like SRC, to ensure stricter supplier selection and qualification, and to manage microbiological risk. 

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 are working closely with our partners at IEH Laboratories on these procedures and we’ll be sharing much more on this as we learn more.

Given these recent findings, is whole milk powder safe? 

Dr. Devon Kuehn: Whole milk powder is a key ingredient in our infant formula because it lets us include more of what's naturally found in breast milk — including components of the milk fat globule membrane (MFGM) and more similarly structured fatty acids. These milk fat components support digestion and the way babies absorb key nutrients. By using organic grass-fed whole milk instead of skim, we retain naturally occurring fats that help bring our formula's composition closer to breast milk — and it means we can rely less on added vegetable oils than formulas made primarily with skim milk.

With the right preventative controls and testing protocols throughout the supply chain and on the finished product, whole milk powder ingredients are safe for infants. ByHeart has had extensive supplier specification in place covering milk products, which had included stringent specifications that cover pathogens (B. cereus, Staphylococcus, E. coli and Salmonella), spores (total spore count & SRC), and hygiene indicators (Enterobacteriaceae and coliforms). 

However, this outbreak is unprecedented in the infant formula category, and it has become clear that the existing safeguards and industry-standard testing must evolve. 

This outbreak revealed that C. botulinum can make its way into the infant formula supply chain, signaling a critical need to strengthen safety and quality measures across infant formula ingredients and manufacturing. ByHeart has directed its resources toward doing just that, and we are working with leading third-party experts in C. botulinum and food safety to validate a set of actions that will benefit not only ByHeart but the infant formula industry at large. We look forward to sharing much more on this in the near future. 

To learn more, please visit ByHeart’s recall updates and FAQs {LINK OUT}.