The safety announcement that isn’t
On October 29th, in Des Moines, HHS Secretary Robert F. Kennedy, Jr. announced the biggest update to infant formula standards in nearly 30 years. The FDA proposed a rule to modernize formula nutrients. It is the first such change since 1998. The agency also released new data on chemical contaminants, and it promised a searchable dashboard. The agency framed it as reassurance. Secretary Kennedy said the FDA would “put babies’ health first.” Most samples, the FDA said, had low or non-detectable contaminants.
Because the standards are nearly three decades old, updating the nutrients is worth doing. So is testing for heavy metals. But neither part of the announcement is about botulism. The proposed rule covers nutrients. The contaminant data covers metals like lead and arsenic. The FDA’s announcement has nothing to do with the outbreaks that sent babies to the hospital.
The reassurance misses the danger
Last year, 48 infants across 17 states were hospitalized with botulism after drinking powdered formula from ByHeart. Botulism paralyzes a baby from the head down. In the worst cases, it reaches the muscles used to breathe. The sickest infants went on ventilators, and some were still recovering months later. This spring, four more infants were hospitalized after drinking formula from Nara Organics. Both brands drew their milk powder from one shared supplier. The FDA found Clostridium botulinum in ByHeart’s milk powder, and its July letter reported a genetic match from that powder to a sick infant. California officials found the same bacteria in an open can of Nara’s. Investigators still cannot say how the powder was contaminated.
A nutrient rule doesn’t do anything about bacterial contamination. Chemical-contaminant testing looks for lead, arsenic, and PFAS. So the reassurance the FDA offered measures a different danger than the one these outbreaks exposed.
Why botulism testing isn’t required
Companies still do not have to test formula or milk powder for Clostridium botulinum. The FDA makes them test finished formula for two other bacteria, Cronobacter and Salmonella. Botulinum is not on the list. In a July letter to the industry, the FDA asked companies to watch their suppliers more closely, but it did not require testing. It sent the question of whether to test to two international science panels for review.
The FDA could label Clostridium botulinum a hazard that requires a control, the same way its rules already treat other germs. Congress could pass H.R. 7867, the March bill that would require this testing, but it hasn't moved since. And through WIC, the federal nutrition program which buys more than half of the formula sold in this country, the federal government could set formula safety requirements.
What the government did instead
The announcement introduced a new rule updating iodine and vitamin D, the first of three planned nutrient rules, and asked whether to require more of a fatty acid called ARA, which aids infant brain development. Last winter, a contaminated batch of ARA oil from a supplier in Wuhan compromised infant formula sold in 10 countries and sickened nearly 150 babies. That oil got into formula through a pathway called GRAS, short for “generally recognized as safe,” a pathway that lets companies add ingredients without clearing them with the FDA first. On GRAS, the new announcement offers only a promise to “consider” tighter rules.
Former FDA employees told my colleagues at KFF Health News that “Operation Stork Speed,” the initiative this falls under, was built by listing the infant formula work already underway, then branding it as a new push. HHS called that account false. The one action with real money behind it came from a courtroom. Last month, Abbott agreed to pay $385 million to settle Justice Department and state claims that it sold formula from an unsanitary plant and billed federal programs for it. Abbott admitted no fault.
Fewer inspectors, same hazard
The announcement landed days before the midterm elections, as some of the administration’s supporters have lost patience over slow progress on food safety.
And the people who could catch it are fewer. Roughly 40% of the inspector jobs for critical-foods plants, formula plants included, sit empty. The administration also shut down a food-safety committee that was studying which babies were most at risk from Cronobacter found at a formula plant.
A parent can check a lot number, but they can’t label a bacteria a hazard, staff an inspection force, move a bill, or set the terms on half the infant formula in the country. The public may submit comments until February 26th at regulations.gov under docket FDA-2026-56789.