FDA Announces Rare Multi-State Outbreak of Infant Botulism Linked to Powdered Infant Formula (PIF)made byByHeart.
A frank conversation about issues that are often missed from updates and some media reports:
- To date, there have been 13 cases of illness in infants associated with the use of PIF manufactured by ByHeart.
- The California Department of Public Health (CDOH) appears to have detected the outbreak through its infant botulism treatment and prevention program and notified the CDC. This is another great example of the States doing detective work on the ground.
- The onset of the disease varies from August to November. What is unusual is that in CDC Updatethe epidemic curve is NOT being published at this time, but it would be nice to see a timeline of the diseases as PIF has a long shelf life (and whether the limited recall will stop additional diseases from occurring).
- IN FDA recommendationsThe agency ONLY advises parents and guardians not to use certain lots of ByHeart, and they “only list two.”
- While being overly cautious (and taking a position with which I agree), CDOH is taking a much stronger stance. They state: “We have tested a sample of the specific infant formula associated with these cases and preliminary tests have come back positive. We urge parents to stop using [ALL] ByHeart Formula Immediately“
- ByHeart, founded in 2016, has a small market share, so baby food shortages are not expected. There is NO need to stock up on supplies.
- ByHeart bills itself as the “next generation” of baby nutrition. As we have seen many times, good marketing does not guarantee safety.
- Alarmingly, ByHeart, although not reported in current articles, also had to recall in December 2022due to possible contamination Cronobacter.
- And they got it warning letterFDA in August 2023.
- Two major recalls and a 3 year warning letter is NOT a good track record, especially in such a critical category targeting the most vulnerable population.
- The outbreak comes at an inconvenient time, as the FDA recently announced. Operation Stork Speedwhich they presented as a groundbreaking initiative aimed at “improving the safety, sustainability and nutritional value of infant formula.”
- While it is noble (and easy) to say that we will improve safety, sustainability and nutrition, the reality is that doing so in this category will be difficult. It will take effort, strong leadership, continued focus, new federal policies and time.
- As this outbreak demonstrates, the risks and complexity of producing PIFs, and the importance of manufacturers of new formulas having strict safety standards, illustrate why it is so difficult for new and/or small companies to enter the market.
Needless to say, this outbreak is very disappointing and our hearts go out to all the babies and families affected.
We CAN—no, we MUST—do better.
