On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the Federal Food, Drug, and Cosmetic Act (FDCA), dietary supplement manufacturers and distributors whose dietary supplements contain “new dietary ingredients” must notify FDA about these ingredients (subject to limited exception). FDA’s new videos and fact sheet seek to address common pitfalls stakeholders experience when submitting NDINs to FDA.
NDIN Fundamentals
- What Are New Dietary Ingredients? Under the FDCA, NDIs are dietary ingredients (i.e., vitamins, minerals, botanicals, amino acids, and substances used to supplement the diet) that were not marketed in the United States before October 15, 1994.
- Who Must Submit an NDIN and When? Either the manufacturer or distributor of the NDI must submit an NDIN. FDA clarifies in guidance that, in its view, manufacturers or distributors of dietary supplements containing an NDI must submit an NDIN unless the NDI manufacturer’s NDIN included information about the dietary supplement at issue. In particular, FDA requires the NDI manufacturer’s NDIN to include a description of the dietary supplement together with the history of use or other evidence of safety that formed the basis of the conclusion that the dietary supplement would reasonably be expected to be safe under its labeled conditions of use. Manufacturers must submit an NDIN to FDA 75 days before marketing a new dietary ingredient (NDI).
- What Information Should and Should Not Be in an NDIN? The NDIN should only contain data or information that identifies the subject NDI or the dietary supplement containing the NDI, or that supports safety of the NDI or the dietary supplement. It should not contain general or extraneous information. For example, the NDIN should not include data or information primarily used to substantiate claims about the efficacy of the ingredient or supplement.
- Meeting with FDA. Firms may voluntarily request meetings with FDA for nonbinding feedback on submitting NDINs. For example, a manufacturer concerned with how to describe its NDI may wish to meet with FDA about the expected detail before submitting an NDIN.
FDA’s New Fact Sheet
This fact sheet highlights five common issues that can cause delays in FDA’s ability to timely process an NDIN or lead to an unfavorable response:
1) The NDIN Does Not Concern a Dietary Ingredient
NDIN submitters must ensure that the subject of the NDIN qualifies as a “dietary ingredient” and clearly explain why it qualifies as a dietary ingredient, including specifying the dietary ingredient category to which the ingredient belongs. Pursuant to the FDCA, a dietary ingredient in a dietary supplement may include any of the following: a vitamin, mineral, herb or other botanical, amino acid, dietary substance (e.g., probiotics), concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the aforementioned categories.
2) The NDIN Does Not Cover the Broadest Possible Use of the NDI
Manufacturers sometimes assume that their product is covered by another firm’s prior NDIN that received no objection from FDA. However, each manufacturer is responsible for submitting its own NDIN.
3) The NDIN Does Not Include Sufficient Identity Information
FDA expects robust identity information, including: (1) a description of the manufacturing process and controls; (2) a description of the physical, chemical, or molecular characteristics of the NDI; and (3) a specification sheet describing purity, strength, and any impurities or contaminants.
4) The NDIN Includes Irrelevant Information
NDINs should only include information relevant to the identity and safety of the NDI and the dietary supplement containing it. Relevant information includes scientific evidence and a safety narrative. FDA recommends against including promotional materials or data not directly related to the identity or safety of the NDI or dietary supplement.
5) The Notifier Fails to Submit Complete References
FDA requires full-text copies of all referenced materials. Abstracts, excerpts, citations alone, general hyperlinks, or incomplete documents will not satisfy submission requirements. Foreign-language sources must be accompanied by an English translation.
FDA Video Guidance on the NDIN Process
FDA’s recently issued videos provide insight into the NDIN-submission process. Manufacturers are responsible for ensuring that any new dietary ingredient (NDI) included in a dietary supplement is safe, manufactured in accordance with quality standards, and properly labeled. FDA maintains premarket authority over NDIs, and understanding what to expect after submitting a NDIN is critical for compliance.
Building on prior FDA guidance, FDA—in these new videos—recommends submitting NDINs electronically through FDA’s online portal. Once submitted, the NDIN is subject to a 75-day review period by FDA. The review includes both scientific and policy evaluations conducted by subject matter experts. During the review period, the product may not be introduced into commerce.
Within that 75-day window, FDA issues a detailed response letter outlining the agency’s findings and any necessary follow-up. Submitters may also receive outreach from FDA staff seeking clarification or additional information. Typically, firms are given three business days to respond to such requests. After the review, FDA issues a detailed response letter addressing the substance of the NDIN.
FDA explains that the NDIN and the FDA’s response letter are kept confidential for 90 days following the date of filing. After that period, both documents, excluding any properly identified trade secrets or confidential commercial information, are made publicly available on Regulations.gov. It is essential for submitters to clearly identify and substantiate any information they consider to be a trade secret or confidential. While FDA ultimately determines what information will be redacted, robust and well-supported notations from the submitter can help guide the agency’s decisions. Importantly, submitters should not redact or block information from FDA’s view. The agency encourages early engagement and pre-NDIN meetings to clarify regulatory expectations and avoid common pitfalls.
FDA’s new materials provide clearer direction for firms navigating the NDIN process. Manufacturers and distributors should review these resources—together with related prior FDA guidance—and consider early engagement with FDA to support timely and successful submissions. Understanding and addressing common pitfalls upfront can help avoid delays and potential regulatory challenges.
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