New Dietary Ingredient (NDI) Notification: When Supplement Brands Must Notify FDA and What the 2026 Guidance Changes

FDA COMPLIANCE · DIETARY SUPPLEMENTS

Updated November 2026. Brands launching gummies, capsules or powders built around a novel botanical extract, a new probiotic strain or a new form of a familiar nutrient often learn about NDI rules late, sometimes from a supplier, a retailer or a marketplace review. This guide explains what counts as a new dietary ingredient, who must notify FDA, what the notification must contain, how the 75-day clock works, what FDA’s response letters mean and what the October 2026 guidance changes. It is general information, not legal advice.

What is a new dietary ingredient?

FDA defines a “new dietary ingredient” as a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994 (section 413(d) of the FD&C Act, 21 U.S.C. 350b(d)). Ingredients marketed before that date are often called “old dietary ingredients” or pre-DSHEA ingredients.

To be a new dietary ingredient, a substance first has to be a dietary ingredient. Under section 201(ff)(1), that means a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance used to supplement the diet by increasing total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any of those. The finished product also has to be a dietary supplement: intended for ingestion, labeled as a dietary supplement and not represented as a conventional food or as the sole item of a meal.

FDA states that there is no authoritative list of dietary ingredients marketed before October 15, 1994. The manufacturer or distributor is responsible for deciding whether an ingredient is new and, if it is not, for documenting that it was marketed in a dietary supplement, or for use in dietary supplements, before that date.

When do you have to notify FDA?

Under section 413(a) of the FD&C Act, a supplement containing an NDI is deemed adulterated unless it meets one of two conditions:

1. Food supply exception. The supplement contains only dietary ingredients that 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. No notification is required in this case.
2. Notification. There is a history of use or other evidence of safety that the NDI will reasonably be expected to be safe under the labeled conditions of use, and the manufacturer or distributor sends FDA that information at least 75 days before introducing the product into interstate commerce.

If you are unsure whether your ingredient is new, FDA says you may still submit a notification. FDA also warns that a product marketed without a required notification is adulterated as a matter of law, and that even when no notification is required, you remain responsible for the safety of the ingredients you use.

Who must submit the NDIN?

Either the manufacturer or distributor of the NDI, or the manufacturer or distributor of the dietary supplement that contains it, must notify FDA. That makes a brand that sells under its own label a distributor in FDA’s terms, even if a contract manufacturer makes the product.

FDA’s 2024 procedures guidance adds a point many brands miss: a notification filed by the ingredient manufacturer does not remove the requirement for the supplement maker or distributor, unless that earlier notification described the dietary supplement (with the details required by 21 CFR 190.6(b)(3)) and the history of use or other evidence of safety for that supplement under its labeled conditions of use. Ask your supplier for the NDIN number and FDA’s response letter, then check whether your dose, form and conditions of use fall inside what was notified.

What must an NDI notification contain?

The NDIN regulation at 21 CFR 190.6 requires:

• Your name and complete address.
• The name of the new dietary ingredient, and for an herb or other botanical, the Latin binomial name including the author.
• A description of the dietary supplement or supplements that contain the NDI, including the level of the NDI in the product and the conditions of use recommended or suggested in the labeling (or the ordinary conditions of use if none are stated).
• The history of use or other evidence of safety establishing that the NDI, used under those conditions, will reasonably be expected to be safe, with full copies of any published materials you cite and English translations of anything in another language.
• The signature of a person you designate who can be contacted about the notification.

FDA encourages electronic submission through its Centralized Online Submission Module (COSM), which confirms receipt and sends status updates by email. Written submissions go to the Office of Dietary Supplement Programs.

How does the 75-day clock and FDA’s review work?

The filing date is the date FDA receives the notification, and the 75-day waiting period starts on that date. FDA sends an acknowledgement with the filing date and an NDIN number, and states that it intends to send a detailed response letter within 75 days of the filing date. Key points from FDA’s 2024 guidance on procedures and timeframes:

• Substantive amendments reset the clock. If you send additional substantive information, the date FDA receives it becomes the new filing date and the 75 days start again.
• Incomplete notifications do not count. FDA does not evaluate safety or identity information in an incomplete NDIN. Common omissions include untranslated material, missing copies of cited publications, no signature or unreachable contact details, and a missing Latin binomial with author citation for a botanical.
• Silence is not a safety finding. Under 21 CFR 190.6(f), FDA’s failure to respond is not a finding that the NDI or the supplement is safe or not adulterated.
• Confidential for 90 days, then public. FDA does not disclose the notification for 90 days after the filing date. After that, the NDIN and FDA’s response letter are placed on public display at regulations.gov, except trade secret and confidential commercial information you identify.

What do FDA’s NDIN response letters mean?

FDA lists the common types of response letters:

FDA publishes a list of NDINs it has reviewed, sortable by number, ingredient, firm and dates, with links to the public docket for each one. It is a practical place to see how FDA has responded to ingredients similar to yours.

What changed with FDA’s October 2026 NDI guidance?

FDA’s NDI notification page, updated October 19, 2026, lists a new final guidance: “New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI” (October 2026, docket FDA-2025-D-6501). It finalizes three sections of FDA’s 2016 revised draft guidance: identity information about the NDI and the supplement, history of use or other evidence of safety, and the summary of the basis for your conclusion of safety. Its topics include:

• Identity. How much detail to give on the manufacturing process, identity specifications in table form, and the component specifications that matter for safety.
• Ingredient types. Extra information for discrete chemical entities, isomers, salts, covalently modified derivatives, botanicals and extracts, metabolites, enzymes, fermentation-derived ingredients and live microbial ingredients.
• Conditions of use. How to describe the serving size, frequency and duration you will recommend on the label, and what to include when an expiration or “use by” date applies.
• History of use. What FDA considers an adequate history of safe use, how to document it, how to explain differences from historical use, and how to estimate intake of historically consumed materials.
• Other evidence of safety. When to include animal and human studies, genetic toxicity and repeat-dose testing, and how to treat studies on test articles that are similar but not identical to your NDI.

Like all FDA guidance, it describes FDA’s current thinking and is not legally binding unless it cites a statutory or regulatory requirement. In practice, it tells you what FDA reviewers expect to see, so an NDIN that ignores it is more likely to draw an objection. FDA also has a 2024 draft guidance on NDI master files, which would let an ingredient owner give customers a right of reference without sharing the underlying data, and a 2022 draft enforcement discretion policy for late notifications that is not final.

How does NDI differ from GRAS and from FDA approval?

GRAS is a food additive concept for substances added to conventional foods. Dietary ingredients in supplements follow the NDI framework instead, although non-dietary components such as sweeteners or coatings can still raise food additive questions. Our FDA GRAS guide explains that side, including FDA’s 2026 proposal to make GRAS notices mandatory.

Neither pathway is a product approval. FDA does not approve dietary supplements before they are marketed, and it does not approve supplement labels or structure/function claims. See are dietary supplements FDA approved? for how to describe your product’s status accurately in listings and ads.

A practical NDI checklist before you launch

1. List every dietary ingredient by exact identity and form, including salts, isomers, extract ratios and microbial strains. A familiar nutrient in a new chemical form can be a new dietary ingredient.
2. Document pre-1994 marketing for anything you treat as an old dietary ingredient, using records you could show FDA.
3. Check FDA’s public NDIN list and your supplier’s file. Ask for the NDIN number and response letter and compare the notified dose, form and conditions of use to yours.
4. Decide who notifies and build the 75 days, plus time for incompleteness or amendments, into the launch calendar.
5. Keep the label and listing consistent with the notified conditions of use. Serving size, daily intake and target population on your label should match what you notified.
6. Keep claims within supplement rules. Structure/function claims need substantiation, a disclaimer and a notice to FDA within 30 days of marketing. Disease claims make the product a drug.

How Eva Commerce helps supplement brands

Eva Commerce does not prepare NDI notifications or safety dossiers; that work belongs with your regulatory consultant and ingredient supplier. Eva handles the FDA filings around the launch: food and supplement facility registration ($240, renewed every two years), U.S. Agent service for foreign facilities ($250 a year), DUNS support, Prior Notice for imports and supplement label review ($340 for a basic formatting review, $590 for a full compliance review). Published prices are on our FDA compliance services page.

Because Eva also runs Amazon, Walmart, TikTok Shop and Shopify growth for supplement brands, the formula, the label and the listing stay consistent. Book a call or call 858-315-2020 before your next ingredient launch.

Frequently asked questions

What is the cutoff date for a new dietary ingredient?

October 15, 1994. A dietary ingredient not marketed in the United States in a dietary supplement before that date is a new dietary ingredient under 21 U.S.C. 350b(d).

How long before launch must I file an NDI notification?

At least 75 days before the supplement is introduced or delivered for introduction into interstate commerce. The clock starts on the date FDA receives the notification and restarts if you submit a substantive amendment.

Does FDA approve new dietary ingredients?

No. FDA reviews the notification and sends a response letter. A letter without objection means FDA found no reason to object to your safety basis, not that FDA independently found the ingredient safe.

Can I rely on my ingredient supplier’s NDI notification?

Only if that notification described a dietary supplement like yours, including the level of the NDI and conditions of use, and the safety evidence for it. Otherwise the supplement manufacturer or distributor must notify FDA too.

Is there an official list of pre-1994 dietary ingredients?

No. FDA says there is no authoritative list. Manufacturers and distributors must decide whether an ingredient is new and keep documentation for any ingredient they treat as marketed before October 15, 1994.

Can Eva Commerce help with an NDI launch?

Eva does not prepare NDI notifications, but handles facility registration, U.S. Agent service, Prior Notice and supplement label review, and keeps marketplace listings consistent with your label. Book a call or call 858-315-2020.

Sources: FDA, New Dietary Ingredient (NDI) Notification Process (content current as of October 19, 2026); FDA, New Dietary Ingredients in Dietary Supplements, Background for Industry; FDA, How to Submit Notifications for a New Dietary Ingredient; FDA guidance, NDI Notifications and Related Issues; Identity and Safety Information About the NDI (October 2026); FDA guidance, NDI Notification Procedures and Timeframes (March 2024); FDA, Submitted 75-Day Premarket Notifications for New Dietary Ingredients; FDA, Questions and Answers on Dietary Supplements; 21 U.S.C. 350b; 21 CFR 190.6. General information, not legal advice.

Related Eva guides: FDA compliance services, FDA GRAS guide, structure/function claims guide, Supplement Facts vs Nutrition Facts, Amazon supplement listing requirements, are dietary supplements FDA approved?.