Food-safety attorney Bill Marler and parents of infants hospitalized in the ByHeart and Nara Organics botulism outbreaks have drafted a citizen petition asking the FDA to require testing of powdered infant formula and its dairy ingredients for botulinum neurotoxin-producing clostridia. Comments on the draft are due by October 30.
What parents should knowCurrent federal rules require finished powdered formula to be tested for Cronobacter and Salmonella. They do not require testing for the spore-forming bacteria that cause infant botulism. Whole-genome sequencing has linked the 2025 ByHeart outbreak (48 infants) and the 2026 Nara Organics outbreak (4 infants) to a shared powdered-milk supplier. All 52 infants were hospitalized; none died. The FDA has sent three letters to the industry since 2023 urging tighter supplier oversight but has not yet written a rule.
Practical steps- Check any remaining Nara Organics or ByHeart product against the recall lists and discard it.- If your infant is formula-fed, ask your pediatrician about current guidance and watch for classic botulism signs: constipation, weak cry, poor feeding, and progressive weakness.- The petition is open for public comment until October 30. Parents and clinicians can review the draft on the Marler Blog and submit comments via the FDA docket process once it is formally filed.- Continue ordinary safe-formula practices: prepare according to the label, store powder dry, and discard prepared bottles after the recommended time.
This is not medical advice. Talk with your child’s clinician if you have concerns about formula safety or infant symptoms.
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