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GUIDANCE DOCUMENT

Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements April 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-0706

Docket Number:
FDA-2024-D-0706
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

This guidance expands upon and replaces the recommendations related to Master Files in the 2016 revised draft guidance (Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues). This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received from stakeholders. For more information, see Constituent Update: FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements. 

This guidance provides recommendations to industry on Master Files for new dietary ingredient  notifications (NDINs).[2] For purposes of this guidance, a new dietary ingredient notification master file (NDIN Master File or Master File) is a file containing identity, manufacturing, and/or safety information relating to a new dietary ingredient (NDI) that the Master File owner submits to FDA for use in evaluating a potential future NDIN by the Master File owner or by another person designated by the owner (e.g., business partner, supplement manufacturer).[3] A Master File contains information about an NDI, a dietary supplement containing an NDI, or both. The Master File owner may refer to the Master File in an NDIN or may grant written authorization to other parties to incorporate information from the Master File by reference in NDINs.  A written authorization granting a right of reference to a Master File in an NDIN does not include the right to see or copy the Master File.

The recommendations in this guidance expand upon and replace the recommendations related to Master Files in FDA’s revised draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (the 2016 revised draft guidance). Our recommendations reflect input received from the public and industry in response to the 2016 revised draft guidance. They also reflect FDA’s discussions with stakeholders.[4]

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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[1] This guidance has been prepared by the Office of Dietary Supplement Programs (ODSP) and the Office of Regulations and Policy in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration (FDA).

[2] A new dietary ingredient (NDI) is a dietary ingredient that was not marketed in the U.S. before October 15, 1994 (21 U.S.C. 350b(d)). Under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI, must submit a premarket notification to FDA at least 75 days before introducing the product into interstate commerce or delivering it for introduction into interstate commerce, unless the NDI and any other dietary ingredients in the dietary supplement “have been present in the food supply as an article used for food in a form in which the food has not been chemically altered” (21 U.S.C. 350b(a)(1)). An NDIN must contain the information, including any citation to published articles, that provides the basis on which the manufacturer or distributor of the NDI or dietary supplement (the notifier) has concluded that the dietary supplement containing the NDI will reasonably be expected to be safe (21 U.S.C. 350b(a)(2)). 

[3] In this guidance, the word “person” includes business entities and other organizations in addition to individuals. 

[4] See, e.g., Public Meeting to Discuss Responsible Innovation in Dietary Supplements (May 16, 2019).  Meeting transcript available at: https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-discuss-responsible-innovation-dietary-supplements.

 
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