Babies and Botulism: Communicating Risk in the By Heart Infant Formula Emergency

Communicating risk information during emergencies is at best challenging, at worst deadly. Fortunately, there are evidence-based strategies to aid health and medical professionals to clearly communicate risk information. One such method is the Crisis and Emergency Risk Communication framework which helps medical professionals plan, create, and share health and risk information during emergencies to prevent and reduce further spread of illness. 1  

The framework is organized by phases of the emergency – initial, maintenance, and resolution – allowing for the right message to get to the right at the right time.1  

As the world was ravaged for years by the COVID-19 – a severe respiratory syndrome coronavirus – many people have become familiar risk messages – these are the very messages the CERC framework can help create. This framework can be used for many different types of health emergencies and outbreaks including infectious and foodborne illnesses.

The Crisis and Emergency Risk Communication framework has three emergency phases: initial, maintenance, and resolution. Organizing messages according to the phase helps health and medical professionals create messages based on what information is known at that time during the health emergency.

The initial phase is often the most challenging phase to communicate, which is fraught with many unknowns: What is the pathogen? What is the transmission route? How severe are the symptoms? Is treatment available?

 This blog post will focus on how the Crisis and Emergency Risk Communication framework offers four specific strategies to communicate when information is uncertain: (1) accept uncertainty, (2) communicate empathy, (3) make a commitment, and (4) offer self-efficacy messages. 1

1. Accept uncertainty

During the early stages of a health emergency while health and medical professionals wait for medical tests to confirm the pathogen and transmission route, risk information still needs to be communicated to those affected by the emergency. To do so, health and medical officials must accept the uncertainty of the situation and communicate what they know, what they don’t know, and what they are doing to find more information about the situation. During the By Heart 2025 infant formula botulism outbreak, the California Department of Health addressed uncertainty by stating what they know and what they are doing about the outbreak:

“The California Department of Public Health is working with other state health departments and the U.S. Centers for Disease Control and Prevention to investigate a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. Preliminary testing of one sample of the formula by the CDPH laboratory suggests the presence of the bacterium that causes botulism. The company has recalled two lots of its product. Consumers with this product should stop using it immediately.” 2

We can see here California did not state what they don’t know in their statement, but an example of what the agency could have stated could be, “At this time we do not know how large this outbreak is, but we are working with other state health agencies to determine the scope of the outbreak. We will let you know as soon as we have more information.” 2

2. Communicate empathy

Empathy is the ability to see and feel a situation from another person’s perspective. Empathy is a form of compassion, where the heart rather than the intellectual mind determines what actions are taken by a person. (Footnote 1) During a health emergency, empathy is so critical to communicate as health and life are vital commodities that once lost are often hard to regain. Throughout many emergencies people may have heard officials say things like “those affected by this emergency are in our thoughts and minds.” This expression is no longer a viable message for health and medical professionals to truly and authentically communicate empathy. In the 2025 ByHeart infant formula outbreak, although the statements are informative, there is little empathy communicated by government health and medical professionals. For example,

“Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time.” said Dr. Erica Pan, CDPH Director and State Public Health Officer. “We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately.”​ 2

In contrast, ByHeart the company implicated in the outbreak used empathy throughout their public statement by expressing apologies and acknowledging the anxiety and fear this type of outbreak can cause of parents of newborn infants:

“We are so sorry for the immense anxiety and fear that we have been causing you these past few days. As parents and as founders, that is the absolute last thing we would ever want to do.” 3 and “At this moment, the most important thing for you to know is that all ByHeart product must be discarded. We know that switching formulas is not an easy process or decision. We have resources to help here.” 3

3. Make a commitment

Another part of an initial message is to make a commitment to those affected by the health emergency. Commitment statements have two parts. First, explain what the agency is doing to find new information about the emerging health crisis. This type of statement informs the audience that the agency has the responsibility for addressing this health threat and is taking action to manage and stop it. Providing this type of statement helps establish credibility in and the authority of the agency during a health response. The second part of a commitment message is letting the community know that the health agency will be there until the end of the health emergency.

From ByHeart the company affected by the outbreak, they offer this commitment statement:

” Upon learning about this outbreak on Friday evening, we immediately began conducting our own extensive testing on all ByHeart batches. Additionally, we are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation, which has been done regularly at our owned facilities. We will share the results of our own testing as they become available.” 3

The California Department of Health a state agency investigating the outbreak provided these commitment statements:

“CDPH has tested a can of powdered infant formula that was fed to an infant with infant botulism.” 2

“CDC, CDPH, and other state health departments are investigating 13 suspected or confirmed infant botulism cases linked to ByHeart powdered infant formula across 10 states.” 2

4. Provide messages of self-efficacy

Messages of self-efficacy promote actions that those affected by the health emergency can take to protect their health. The term “self-efficacy” comes from research literature focused on one’s personal efficacy or ability or capacity to carry out a particular action. The term is used in emergency risk communication under the assumption that people have a level of efficacy or capacity to carry out simple actions to protect their health. Further, providing people with something to do during an emergency reduces anxiety. 1

In the infant baby formula outbreak, the self-efficacy messages was clear from California Department of Health, CDC, and the infant formula company ByHeart: throw out the formula and seek medical attention immediately if an infant exhibits symptoms of botulism. 2, 3, 4

The company ByHeart also offers additional steps parents can take on how to switch formula brands and to answer any questions parents through the company’s Parent Experience team. 3

By using these strategies during the initial phase of a health emergency, health and medical professionals – and even private sector business as shown in this infant formal outbreak example – can clearly communicate health and risk information, reduce anxiety for those affected by the emergency, and even bolster organizational credibility by acknowledging what they know, what they don’t know, and what they are doing to find more information.

To learn more about communication strategies during the maintenance and resolution phases of a health emergency, please check out Dr. Kathleen Melville’s book Risk Communication in Public Health Emergencies. 1

Sources

1. https://www.cambridge.org/core/books/risk-communication-in-public-health-emergencies/67EA5A298F542AFD0EC748166E3DA785

2. https://www.cdph.ca.gov/Programs/OPA/Pages/NR25-017.aspx

3. https://byheart.com/pages/an-update-from-our-founders-on-our-voluntary-recall-november-2025

4. https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/investigation.html

Further reading

By Heart Voluntary Recall Information

https://byheart.com/pages/an-update-from-our-founders-on-our-voluntary-recall-november-2025

U.S. Food and Drug Administration ByHeart Recall Information

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/byheart-broadens-voluntary-recall-while-investigation-continues

Associated Press News

https://apnews.com/article/byheart-baby-formula-infant-botulism-recall-e070565daaf1f425e3d37dca20277714

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Risk Communication in Public Health Emergencies: Practical Guidance Rooted in Theory
Written by: Kathleen G. V. Melville,

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