[Federal Register Volume 90, Number 92 (Wednesday, May 14, 2025)]
[Notices]
[Pages 20475-20477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08419]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1134]
Infant Formula Nutrient Requirements; Request for Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information.
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SUMMARY: 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.
DATES: Either electronic or written comments on the notice must be
submitted by September 11, 2025.
ADDRESSES: You may submit comments and information as follows. Please
note that late, untimely filed comments will
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not be considered. The https://www.regulations.gov 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.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): 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.''
Instructions: 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
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov 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 https://www.regulations.gov. 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:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION:
I. Background
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.
II. Issues for Consideration and Request for Information
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
[[Page 20477]]
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 Federal Register
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 a minimum level, which, if any, should have
a maximum level added? Please explain your rationale. For example,
describe how changes might positively impact health outcomes.
5. What other nutrients (e.g., docosahexaenoic acid and arachidonic
acid) or specifications for nutrients (e.g., ratio of linoleic acid to
alpha-linolenic acid), if any, should we consider adding to 21 CFR
107.100? Please explain your rationale.
6. Which nutrients, if any, should we remove from 21 CFR 107.100?
Please explain your rationale.
III. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they also are
available electronically at https://www.regulations.gov. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.
1. Raiten, D.J., J.M. Talbot, and J.H. Waters, Life Sciences
Research Office, American Society for Nutritional Sciences,
``Assessment of Nutrient Requirements for Infant Formulas,'' Journal
of Nutrition, 128 (11 Suppl) (November 1998): i-iv, 2059S-2293S.
Available at https://doi.org/10.1093/jn/128.suppl_11.2059S.
Dated: May 7, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08419 Filed 5-13-25; 8:45 am]
BILLING CODE 4164-01-P