Overview
- The FDA published the first-phase proposal on Thursday, Oct. 29, to change requirements for iodine, vitamin A, vitamin D and manganese and set a new manganese cap.
- Specific numeric changes would triple the iodine minimum to 15 micrograms with a 50 microgram upper limit, reduce manganese minimum to 1 µg per 100 kcal with a 50 µg cap, lower vitamin A slightly and change its unit to retinol activity equivalents, and double the vitamin D minimum to 2 µg while raising the maximum to 3 µg.
- The agency released new contaminant-testing data and a public dashboard showing most formula samples had low or non-detectable levels of heavy metals, PFAS and phthalates while some results remain under follow-up.
- The rule is the first comprehensive nutrient review in nearly 30 years, is part of Operation Stork Speed, will be phased with external peer review, opens a comment period through March 2, 2027, and includes an estimated annual industry cost range of $8.4 million to $31.7 million with a central estimate of $17.6 million.
- FDA is also seeking public input on commonly added ingredients such as DHA, ARA and L-carnitine and has urged stronger supplier oversight after recent recalls and infant botulism cases, a move that could change what manufacturers must include and how products are monitored.