Lessons unlearned – Powdered infant formula making babies sick again

FDA has announced a rare multi-state outbreak of Infant Botulism linked to the consumption of powdered infant formula (PIF) made by ByHeart.

Straight Talk on points often left out in updates and some media reports:

There have been 13 cases to date among infants with illnesses linked to the consumption of PIF produced by ByHeart.
The California Department of Health (CDOH) appears to have picked up the outbreak through their Infant Botulism Treatment and Prevention Program and notified the CDC. This is another great example of the States doing the boots-on-the-ground detective work.
Illness onset dates range from August to November. Unusually, in the CDC update, an epidemic curve is NOT currently posted, but it would be nice to see the timeline of illnesses, as PIF has a long shelf life (and whether or not the limited recall stops additional illnesses).
In the FDA advisory, the agency ONLY recommends that parents and caregivers should not use certain lots of ByHeart, and they “only list two.”
In an abundance of caution (and in position I agree with), the CDOH takes much stronger posture. They state, “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 [ALL] ByHeart formula immediately.”
ByHeart, founded in 2016, has a small market share, so shortages of infant formula are not expected. There is NO need to stock up on supplies.
ByHeart bills themselves as the “next generation” of infant formula. As we’ve seen repeatedly, good marketing doesn’t guarentee safety.
Disturbingly, while not reported in current stories, ByHeart also had to recall products in Dec 2022 due to potential contamination with Cronobacter.
And they received a warning letter by FDA in August of 2023.
Two major recalls and a warning letter in 3 years is NOT a good track record, especially in such a critical category intended for the most vulnerable.
The outbreak comes at an inconvenient time, as the FDA recently announced Operation Stork Speed, which they unveiled as groundbreaking initiative to “strengthen the safety, resilience, and nutrition of infant formula.”
While saying we’ll improve safety, resiliency, and nutrition is noble (and easy), the reality is that it will be hard to do in this category. It will take effort, strong leadership, continual focus, new federal policies, and time.
As this outbreak shows, the risks and complexity of manufacturing PIF, and the importance of new formula manufacturers having strict safety standards, illustrates just why it’s so difficult for new and/or small companies to enter the market.