Infant Formula Nutrient Requirements; Request for Information

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-1134]</DEPDOC> <SUBJECT>Infant Formula Nutrient Requirements; Request for Information</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice; request for information. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is requesting information and data to begin the nutrient review process for infant formula. We are taking this action, in part, to continue to ensure the nutritional adequacy of infant formula sold in the United States. We intend to use the information and data to help determine what type(s) of actions, if any, should be taken. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Either electronic or written comments on the notice must be submitted by September 11, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments and information as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 11, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2025-N-1134 for “Infant Formula Nutrient Requirements; Request for Information.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Carrie Assar, Office of Critical Foods, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1453, or Holli Kubicki, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> Section 412(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350a(i)) establishes requirements for the nutrient content of infant formulas. Under section 412(i)(2) of the FD&C Act, the Secretary of Health and Human Services is authorized to revise the list of required nutrients and the required level for any required nutrient. In addition, section 412(i)(1) of the FD&C Act requires the Secretary to review the table of required nutrients “every 4 years as appropriate,” taking into consideration “any new scientific data or information related to infant formula nutrients, including international infant formula standards.” These authorities have been delegated to the Commissioner of Food and Drugs. The table in section 412(i) of the FD&C Act and FDA regulations at 21 CFR 107.100 specify that infant formulas must contain 30 nutrients; minimum levels for each nutrient and maximum levels for 10 of the nutrients are also specified. Although FDA regularly reviews individual nutrient requirements for infant formula, our last comprehensive review was in 1998 (Ref. 1). We last updated the table in 21 CFR 107.100 in 2015 to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula (80 FR 35834 (June 23, 2015)). On March 18, 2025, the Department of Health and Human Services and FDA announced “Operation Stork Speed” to expand options for safe, reliable, and nutritious infant formula for American families. As part of Operation Stork Speed, FDA announced a set of actions and initiatives focused on infant formula, such as beginning the nutrient review process and increasing testing for heavy metals and other contaminants. We are also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients. These enhanced FDA commitments are focused on making sure a strong supply of infant formula—which is often the sole source of nutrition for infants—remains available for one of our nation's most vulnerable populations. <HD SOURCE="HD1">II. Issues for Consideration and Request for Information</HD> FDA is issuing this request for information to begin the nutrient review process for infant formula intended for healthy, full-term infants. Specifically, FDA is interested in information that would help us determine whether there is a need to revise the existing nutrient requirements in 21 CFR 107.100, taking into consideration any new scientific data or information related to infant formula nutrients, including international infant formula standards. For purposes of this request for information, the term “nutrient” means any vitamin, mineral, or other substance or ingredient that is required in accordance with the table set out in section 412(i)(1) of the FD&C Act or by 21 CFR 107.100, or that is identified as essential for infants by the Food and Nutrition Board of the Institute of Medicine through its development of a Dietary Reference Intake, or that has been identified as essential for infants by FDA through a <E T="04">Federal Register</E> publication (see 21 CFR 106.3 (definition of “nutrient”)). We invite comment on the questions below. Please explain your answers and provide references and data, if possible. 1. What new scientific data or information since the 1998 comprehensive assessment (Ref. 1) should we consider regarding nutrient requirements for healthy, full-term infants that are associated with positive short- and/or long-term health outcomes? 2. What scientific data or information have emerged since the 1998 comprehensive assessment (Ref. 1) regarding nutrient intakes for healthy, full-term infants that are associated with poor short- and/or long-term health outcomes? 3. Which existing nutrients required in 21 CFR 107.100 should we review? Please explain your rationale. 4. For the nutrients required in 21 CFR 107.100, what, if any, adjustments should be made to existing minimum or maximum levels? For the 20 nutrients with only ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 12k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━