Story perspectives

FDA Proposes New Infant Formula Vitamin D, Iodine Limits

By Drooid · Oct 31, 2026 · How we work

Read the story

Story summary

Summary

The FDA proposed a rule to update infant formula nutrient requirements.
Rule would raise vitamin D to 2 µg minimum and 3 µg maximum per 100 calories.
It would raise iodine minimum to 15 µg and cap ceiling at 50 µg per 100 calories.
Manganese would be set at a 1 µg minimum and 50 µg upper limit per 100 calories.
Comments are accepted on regulations.gov until Feb. 26, 2027; testing showed most samples low or non-detectable.

Summary

The FDA estimates the rule will cost manufacturers $8.4 million to $31.7 million annually, with a primary estimate of $17 million.
FDA urged formula makers and supply-chain partners to exercise substantive oversight after recent product recalls and infant botulism cases.
The proposal would allow a new source of vitamin A in infant formula.
FDA plans an external peer review of all scientific information before finalizing the rule.

1 of 2

FDA Proposes Formula Rule

The FDA proposed a rule to update infant formula nutrient requirements.
Rule would raise vitamin D to 2 µg minimum and 3 µg maximum per 100 calories.
It would raise iodine minimum to 15 µg and cap ceiling at 50 µg per 100 calories.
Manganese would be set at a 1 µg minimum and 50 µg upper limit per 100 calories.
Comments are accepted on regulations.gov until Feb. 26, 2027; testing showed most samples low or non-detectable.

1 / 2