Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Action Levels for Cadmium in Processed Food Intended for Babies and Young Children." The draft guidance, when finalized, will establish action levels for cadmium in certain processed foods intended for babies and young children less than 2 years old. The draft guidance is intended to set achievable action levels that will help further reduce cadmium in the food supply.

Full Text

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<title>Federal Register, Volume 91 Issue 204 (Friday, October 23, 2026)</title>
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[Federal Register Volume 91, Number 204 (Friday, October 23, 2026)]
[Proposed Rules]
[Pages 66796-66797]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21670]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 109

[Docket No. FDA-2025-D-4023]


Action Levels for Cadmium in Processed Food Intended for Babies 
and Young Children; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Action Levels for Cadmium in Processed Food Intended for Babies and 
Young Children.'' The draft guidance, when finalized, will establish 
action levels for cadmium in certain processed foods intended for 
babies and young children less than 2 years old. The draft guidance is 
intended to set achievable action levels that will help further reduce 
cadmium in the food supply.

DATES: Submit either electronic or written comments on the draft 
guidance by December 22, 2026 to ensure that the Agency considers your 
comments on the draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit either electronic or written/paper comments 
on FDA guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
will be posted to

[[Page 66797]]

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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-D-4023 for ``Action Levels for Cadmium in Processed Food 
Intended for Babies and Young Children; Draft Guidance for Industry.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: 
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Office of Food Chemical Safety, Dietary Supplements, and 
Innovation; Human Foods Program; Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740. Send two self-addressed adhesive 
labels to assist that office in processing your request. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance.

FOR FURTHER INFORMATION CONTACT: Eileen Abt, Office of Food Chemical 
Safety, Dietary Supplements, and Innovation; Human Foods Program; Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1529; or Barbara Little, Office of Regulations and International 
Programs; Human Foods Program; Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Action Levels for Cadmium in Processed Food Intended for 
Babies and Young Children.'' We are issuing the draft guidance 
consistent with our good guidance practices regulation (21 CFR 10.115). 
The draft guidance, when finalized, will represent the current thinking 
of FDA on this topic. It does not establish any rights for any person 
and is not binding on FDA or the public. You can use an alternate 
approach if it satisfies the requirements of the applicable statutes 
and regulations.
    This draft guidance, when finalized, would, in accordance with 
Sec.  109.6 (21 CFR 109.6), establish the following action levels for 
cadmium in processed food intended for babies and young children less 
than 2 years old: 10 parts per billion (ppb) for fruits, vegetables 
(excluding single-ingredient carrots), and mixtures (including grain- 
and meat-based mixtures); 25 ppb for single-ingredient carrots; 45 ppb 
for dry infant cereals; 20 ppb for yogurts, puddings, and custards; and 
25 ppb for single-ingredient meats. Consistent with Sec.  109.6(d), 
these action levels would reflect levels of cadmium at which FDA may 
regard the food as adulterated within the meaning of section 402(a)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)). We 
intend to consider these action levels, in addition to other factors, 
when considering whether to bring enforcement action in a particular 
case.
    We request comments on these proposed action levels in general, 
including on whether there may be sufficient data or information that 
would support different levels for these categories of foods.
    As we develop final guidance on this topic, FDA will consider 
comments on costs or cost savings the guidance may generate, relevant 
for Executive Order 14192.

II. Paperwork Reduction Act of 1995

    This draft guidance contains no collection of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21670 Filed 10-22-26; 11:15 am]
BILLING CODE 4164-01-P


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