A draft petition seeking public comment would require lot-by-lot testing of dairy ingredients and powdered infant formula after outbreaks linked to contaminated supply chains hospitalised dozens of babies.
Comments are being sought on a draft petition asking the US Food and Drug Administration to require powdered infant formula, and the dairy ingredients used to make it, to be tested for the bacteria that can cause infant botulism. The petition, written by attorney Bill Marler, argues that no new law is needed because the FDA already controls the testing list and can amend it itself. It is intended to push the agency to act after a series of outbreaks that have left dozens of infants hospitalised. According to the FDA, the issue sits within its existing infant formula safety framework, which already requires testing for certain pathogens and has been under renewed scrutiny after recent contamination concerns.
Marler says he plans to file the petition alongside the parents of 23 infants who were hospitalised after being fed powdered formula, including families affected by the ByHeart and Nara Organics outbreaks. The draft says FDA added Cronobacter to its infant formula testing requirements in 2014 after concluding that voluntary industry checks might not be enough for a product that can be an infant’s only source of nutrition. The petition also points to a March 2023 letter from the FDA commissioner naming Clostridium botulinum as a hazard that formula makers should consider when designing controls.
The latest outbreak information has sharpened the case for broader testing. FDA investigations linked two infant botulism outbreaks through whole-genome sequencing, with the agency saying the evidence pointed to a common source involving milk supplied by Organic West Milk and spray-dried by Dairy Farmers of America. The agency said the ByHeart outbreak sickened 48 infants in 17 states, while the Nara Organics outbreak affected four infants in California, Pennsylvania and Washington. CDC and FDA updates also show how difficult it can be to trace contamination once it enters the supply chain, particularly when the ingredient, rather than the finished plant environment, is the likely source.
That distinction is central to the petition. Marler argues that plant-based environmental swabs alone would not have detected the hazard if the organism entered through contaminated dairy ingredients. He cites FDA sampling of powdered milk from multiple suppliers and says the agency found positives in material carrying a botulinum toxin gene. The draft petition therefore asks FDA to require lot-by-lot testing of dairy ingredients before they are used, to require one-business-day notification of any confirmed positive result and to finalise a validated testing method within 180 days. It also seeks stronger traceability, including records showing where milk was dried and which farms supplied it.
Marler says he wants comments from scientists, laboratories, public health officials, formula manufacturers, dairy processors, paediatricians and parents. He is asking whether the proposed finished-product sampling plan is practical at commercial scale, whether the ingredient list is drawn correctly and whether farm-level traceability is workable in practice. He also wants evidence on cost, laboratory capacity and method performance, as well as any information that cuts against the petition. Comments are due by Friday, 30 October 2026. The petition does not call for any brand ban, but instead seeks to tighten the testing net before formula reaches families.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
