The U.S. Food and Drug Administration put forward the first-ever overall revision of infant formula nutrition requirements in 1998. This proposal sets new requirements for four specific infant formula nutrients and asks for public feedback on whether other nutrients should also be set.
The proposal, announced on October 29, 2026, is the first stage of a full revision of the 30 nutrients currently required in infant formula in the U.S. The changes aim to align requirements with the latest science on infant growth and development.
However, this is still a proposal and will not become law immediately.
FDA Began Reviewing Eight Required Formula Nutrients
The infant formula proposal includes eight of the 30 required nutrients. These include setting new requirements for iodine, manganese, vitamin A and vitamin D. The other nutrients, chloride, potassium, selenium and sodium, are being reviewed.
This is based on the scientific evidence published since the last overall assessment back in 1998.
The three-stage approach is being taken because each nutrient requires a different level of scientific analysis. The first stage reviews nutrients for which the agency has completed its scientific review.
Proposed Changes Included New Limits for Four Nutrients
The proposed rule would have changed the minimum or maximum levels of four nutrients:
- Iodine: The minimum would have increased from 5 to 15 micrograms per 100 calories, while the maximum would have decreased from 75 to 50 micrograms.
- Manganese: The minimum would have decreased from 5 to 1 microgram per 100 calories and the maximum would have been set at 50 micrograms.
- Vitamin A: The minimum requirement would reduce from 250 IU to 70 micrograms and the maximum from 750 IU to 120 micrograms, with sources limited to preformed vitamin A.
- Vitamin D: The minimum would have increased from 40 IU to 2 micrograms per 100 calories, while the maximum would have increased from 100 IU to 3 micrograms.
The proposal would change the units used to declare vitamins A and D on formula labels.
FDA Kept Four Other Nutrient Requirements Unchanged
After reviewing the evidence, the four nutrients, chloride, potassium, selenium and sodium, were found to be correctly set.
Therefore, all four would have been kept to the previous minimum and maximum requirements.
It should also be noted that the first stage of the proposal includes no new or removed mandatory nutrients. It simply updates existing mandatory requirements. It also aims to gather more scientific data on common ingredients already used in many formulas.
Agency Sought Input on Additional Nutrients
The FDA also asked for public feedback on whether certain ingredients should be made mandatory.
Manufacturers commonly add these ingredients and evidence suggests they may play a role in infant development. They include Docosahexaenoic acid ( DHA), Arachidonic acid (ARA) and L-carnitine.
Other nutrients to be reviewed in the next two stages include vitamin E, various B vitamins, vitamin C, choline, protein, fats, iron, calcium and other minerals. They will also review carbohydrate sources.
The overall aim is to publish two further proposals.
Parents Could Continue Using Existing Formula Products
The FDA stated that the changes are not due to any safety issues with current infant formula products. The current products remain safe for babies and are still regulated.
The FDA published the proposal in the Federal Register on November 2, 2026. Comments can be submitted until March 2, 2027. If the final rule mirrors the proposed rule, it would go into effect 60 days after publication. Manufacturers would then have three years from the effective date to reformulate and re-label.
The FDA also said it will monitor the supply chain during this time to minimize disruption.
