The FDA is proposing the first update to U.S. infant formula nutrient standards in nearly 30 years. The October 29 proposal would revise or reaffirm parts of the federal rules that govern what must be in formula sold in the United States.
For families, the move matters because those rules set the baseline for nutrients in a product many babies rely on every day. The agency also released new contaminant testing information and said most sampled formulas showed low or non-detectable levels for the chemicals it measured.
What the current standards cover
Under existing federal law and FDA regulations, infant formula sold in the United States must contain 30 required nutrients. The rules set minimum levels for all 30, and maximum levels for 10 of them, according to the FDA and a 2025 Federal Register notice seeking information on formula nutrients.
The FDA said its new proposal is the first phase of a broader review of those requirements. In this round, the agency would update or reaffirm specifications for eight of the 30 required nutrients, and it would also change the units of measure for two nutrients.
According to the FDA’s proposed rule materials, the changes are meant to reflect ...