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October 30, 2026

In the wake of botulism cases, FDA says its latest baby formula testing is 'reassuring'

The FDA also is updating nutrient requirements for infant formulas as part of its first comprehensive review since 1998.

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FDA Infant Formula Alison Young/USA Today Network via Reuters Connect

The FDA has proposed new nutrient requirements for infant formula.

The Food and Drug Administration said Thursday that a second round of infant formula contaminant testing revealed "reassuring results."

The FDA started testing for contaminants in the wake of product recalls and botulism cases linked to infant formulas. In April, the agency announced that the first round of testing found the U.S. infant formula supply was safe.


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"Most infant formula samples tested by the FDA had low or non-detectable levels of chemical contaminants," acting FDA Commissioner Kyle Diamantas said in a news conference. "Again, that's consistent with the data we released earlier this year in our first tranche of chemical contaminant testing."

The FDA has created a website and dashboard for the public to track infant formula testing.

Additionally, FDA said it plans to update its nutrient requirements for infant formula, which will come out in three phases. It's the first comprehensive review of infant formula since 1998.

If finalized, the new requirements will change limits for iodine, vitamin A, vitamin D and manganese while reaffirming existing requirements for chloride, potassium, selenium and sodium.

"We're also requesting public input on ingredients that are not currently required in infant formula, but are commonly added by manufacturers and are actually required in some other countries," Diamantas said.

That list includes arachidonic acid and docosahexaenoic acid — both fatty acids — and L-carnitine, an amino acid.

"There's evidence that these nutrients contribute to neurodevelopment, health and infancy, and we want to hear from the scientific community, from clinicians, from industry and the public as we consider whether or not to make these nutrients mandatory in the U.S. infant formula supply," Diamantas said.

Ultimately, the FDA will complete a review of all 30 infant formula required ingredients, consolidating the findings in a "final, comprehensive rule," Diamantas said.

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