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Friday, October 30, 2026

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Health · Friday, October 30, 2026

FDA proposes first full infant-formula nutrient review since 1998

The File desk · Oct. 30, 2026, 6:37 a.m. ET

Confirmed2 primary sources

Status

Confirmed. FDA filed a proposed rule on October 29, 2026, titled Infant Formula Nutrient Requirements. It is scheduled to be published in the Federal Register on November 2. It is not in effect.
  • Confirmed
    The agency calls this the first comprehensive update and review of infant formula nutrients since 1998. The proposal covers 8 of 30 required nutrients.
  • Confirmed
    If finalized, iodine, vitamin A, vitamin D, and manganese would change. Chloride, selenium, potassium, and sodium would stay.
The Food and Drug Administration on Thursday filed a proposal that would change how much of four nutrients infant formula must contain. The agency calls it the first comprehensive update and review of those nutrients since 1998. Formula makers do not have to follow it yet.1
The document is a proposed rule, a draft asking for comment, not a final order. It was filed at 11:15 a.m. on October 29 and is scheduled to be published on November 2. The public-inspection page does not name a time zone. Comments would be due 120 days after publication.21
The draft looks at 8 of the 30 nutrients formula must contain. If it became final, it would change iodine, vitamin A, vitamin D, and manganese. It would leave chloride, selenium, potassium, and sodium where they are. The agency says the rest of the nutrients will come in later proposals, then one final rule.1
Why it matters (Estimate). Estimate. Parents buying formula this week are still under the current rules. If a final rule is published, it would raise the floor for some nutrients and lower the ceiling for others, in what the agency says is its first full nutrient review since 1998. The comment deadline starts after the November 2 publication and runs 120 days. Nothing in the draft changes a can already on the shelf.
The draft says any final rule should take effect 60 days after it is published, and that companies would have 3 years after that effective date to comply. The proposal cites the . The levels in the footnotes are the draft, not the tubs on a store shelf today.1
How we know

Notes

  1. 1.Food and Drug Administration, proposed rule, “Infant Formula Nutrient Requirements,” Docket No. FDA-2026-N-10832, RIN 0910-AJ34, document 2026-22273, 21 CFR Parts 107 and 184. https://public-inspection.federalregister.gov/2026-22273.pdf Filed for public inspection; scheduled to be published in the Federal Register on 2026-11-02. “This is the first comprehensive update and review of infant formula nutrients by the FDA since 1998.” The proposal assesses 8 of the 30 required nutrients. If finalized it would amend minimum and/or maximum levels of iodine, vitamin A, vitamin D, and manganese, and establish a maximum for manganese. Chloride, selenium, potassium, and sodium stay at current levels. Iodine minimum would rise from 5 µg/100 kcal to 15 µg/100 kcal, and the maximum would fall from 75 µg/100 kcal to 50 µg/100 kcal. Vitamin A minimum would fall from 250 IU/100 kcal (75 μg RAE/100 kcal) to 70 μg RAE/100 kcal, and the maximum from 750 IU/100 kcal (225 μg RAE/100 kcal) to 120 μg RAE/100 kcal. Vitamin D minimum would rise from 40 IU/100 kcal (1 μg/100 kcal) to 2 μg/100 kcal (80 IU/100 kcal), and the maximum from 100 IU/100 kcal (2.5 μg/100 kcal) to 3 μg/100 kcal (120 IU/100 kcal). Manganese minimum would fall from 5 μg/100 kcal to 1 μg/100 kcal, with a new maximum of 50 μg/100 kcal. Comments are due 120 days after Federal Register publication. “We intend that any final rule resulting from this rulemaking become effective 60 days after the date of the final rule’s publication.” Proposed compliance date: 3 years after the effective date. Authority cited: sections 201(z), 403(j), 412(i), and 701(e) of the (21 U.S.C. 321(z), 343(j), 350a(i), and 371(e)).
  2. 2.Federal Register public inspection, “Infant Formula Nutrient Requirements,” document 2026-22273. https://www.federalregister.gov/public-inspection/2026-22273/infant-formula-nutrient-requirements An unpublished proposed rule by the Food and Drug Administration. Filed at 10/29/2026 at 11:15 am. Scheduled publication date 11/02/2026. 155 pages. The page says public-inspection documents are unpublished.

What is still unknown or disputed

  • Whether the November 2 publication happens as scheduled. The public-inspection page says the document is unpublished and scheduled for that date.
  • What the later proposals will do with the other 22 required nutrients. This document says they come later.
  • The FDA web page that summarizes the same rule. That address returned 404 from this desk. The proposed-rule PDF and the public-inspection page are the sources.

Primary sources

Every claim in this story is drawn from the documents below. If a fetch failed, that is recorded on the card.

  1. Source 1

    Infant Formula Nutrient Requirements, proposed rule PDF

    Food and Drug Administration · October 29, 2026

    FDA proposes the first comprehensive update of infant formula nutrients since 1998. Four nutrients would change. The rule is not final.

    https://public-inspection.federalregister.gov/2026-22273.pdf

  2. Source 2

    Public Inspection: Infant Formula Nutrient Requirements

    Federal Register · October 29, 2026

    Unpublished proposed rule, filed October 29, 2026, at 11:15 a.m., scheduled for publication on November 2, 2026. 155 pages.

    https://www.federalregister.gov/public-inspection/2026-22273/infant-formula-nutrient-requirements