New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry." The guidance focuses on frequently asked questions about the new dietary ingredient notification (NDIN) submissions. This guidance is intended to help provide recommendations to manufacturers and distributors of NDIs and dietary supplements containing an NDI regarding the identity and safety information that should be included in an NDIN.

Full Text

<html>
<head>
<title>Federal Register, Volume 91 Issue 201 (Tuesday, October 20, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 201 (Tuesday, October 20, 2026)]
[Notices]
[Pages 66336-66337]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21453]



[[Page 66336]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-D-6501]


New Dietary Ingredient (NDI) Notifications and Related Issues; 
Identity and Safety Information About the NDI: Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry entitled ``New Dietary 
Ingredient (NDI) Notifications and Related Issues; Identity and Safety 
Information About the NDI: Guidance for Industry.'' The guidance 
focuses on frequently asked questions about the new dietary ingredient 
notification (NDIN) submissions. This guidance is intended to help 
provide recommendations to manufacturers and distributors of NDIs and 
dietary supplements containing an NDI regarding the identity and safety 
information that should be included in an NDIN.

DATES: The announcement of the guidance is published in the Federal 
Register on October 20, 2026.

ADDRESSES: You may submit either electronic or written 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 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-6501 for ``New Dietary Ingredient (NDI) Notifications and 
Related Issues; Safety Information About the NDI: 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 guidance to the 
Office of Dietary Supplement Programs, 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 guidance.

FOR FURTHER INFORMATION CONTACT: Gerie Voss, Office of Dietary 
Supplement Programs, Office of Food Chemical Safety, Dietary 
Supplements, and Innovation, Human Foods Program, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-620-9744; 
or Lauren Kleinman, Division of Human Foods Regulations, Office of 
Regulations & 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 guidance for industry 
entitled ``New Dietary Ingredient (NDI) Notifications and Related 
Issues; Identity and Safety Information About the NDI: Guidance for 
Industry.'' We are issuing this guidance consistent with our good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
our current thinking 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 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.
    In the Federal Register of July 5, 2011 (76 FR 39111), we announced 
the availability of a draft guidance for industry entitled ``Draft 
Guidance for Industry; Dietary Supplements: New Dietary Ingredient 
Notifications and Related Issues'' and gave interested parties an 
opportunity to submit comments by October 3, 2011. Among other topics, 
the July 2011 draft

[[Page 66337]]

guidance discussed FDA's views and recommendations on when an 
ingredient intended for use in a dietary supplement is an NDI, when the 
requirement to submit an NDIN to FDA applies, the types of data and 
information that manufacturers and distributors should consider when 
they evaluate the safety of a dietary supplement containing an NDI, 
what to include in an NDIN (including recommendations about identity 
and safety information), and the procedures for submitting an NDIN. We 
received significant comments and decided to issue a revised draft 
guidance.
    In the Federal Register of August 12, 2016 (81 FR 53486), we 
announced the availability of a revised draft guidance for industry 
entitled ``Dietary Supplements: New Dietary Ingredient Notifications 
and Related Issues; Revised Draft Guidance for Industry'' to replace 
the July 2011 draft guidance. We gave interested parties an opportunity 
to submit comments on the 2016 revised draft guidance by October 11, 
2016. On October 4, 2016, we extended the comment period for the 
revised draft guidance to December 12, 2016 (81 FR 68434).
    The final guidance, whose availability we are announcing through 
this document, finalizes in a stand-alone document the identity and 
safety recommendations that had been in sections VI.A, ``Identity 
Information about the NDI and the Dietary Supplement,'' VI.B, ``History 
of Use or Other Evidence of Safety,'' and VI.C, ``Summary of the Basis 
for Your Conclusion of Safety,'' of the 2016 draft guidance. To help 
alleviate the burden of submitting separate documents regarding the 
safety data submitted in an NDIN, we eliminated the references to a 
``comprehensive safety profile'' and, instead, recommend use of a 
single ``safety narrative'' for all NDINs. We made changes to provide 
additional clarity and description regarding what should be included in 
the NDIN safety narrative, when additional evidence of safety should be 
submitted, and what types of studies are recommended to support an 
NDIN. Finally, the guidance contains editorial changes to improve 
clarity.
    FDA has also updated the 2016 revised draft guidance to indicate 
which portions have been finalized and which portions remain in draft 
status (see <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-new-dietary-ingredient-notifications-and-related-issues">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-new-dietary-ingredient-notifications-and-related-issues</a>).
    FDA considered the applicability of Executive Order 14192 and finds 
this action to be neither an E.O. 14192 regulatory action nor an E.O. 
14192 deregulatory action.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information in 21 CFR 190.6 and found in the guidance 
have been approved under OMB control number 0910-0330.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
<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. 2026-21453 Filed 10-19-26; 8:45 am]
BILLING CODE 4164-01-P


</pre></body>
</html>