What makes an ingredient a 'new dietary ingredient'?

One not marketed in a dietary supplement in the US before October 15, 1994, under 21 U.S.C. 350b(d). There is no authoritative FDA list of what was marketed before that date, so the manufacturer or distributor is responsible for determining this and documenting evidence either way.

Does every NDI require a notification?

Not if the ingredient has been present in the food supply as an article used for food, in a form where the food hasn't been chemically altered. If it hasn't, a notification is required unless the ingredient falls outside that carve-out for some other documented reason.

Who is required to submit the notification, me or my manufacturer?

Either a manufacturer or a distributor can file, and FDA's guidance lists both a firm intending to market the NDI itself and a firm intending to market a supplement containing it as required filers. In practice, whoever controls the safety information typically files, but the brand owner should confirm one specific party has, rather than assume the other did.

What happens if a required notification was never filed?

FDA states plainly: if a notification is required and the product is marketed without it, the product is adulterated as a matter of law, regardless of whether the ingredient is actually unsafe. It is a paperwork trigger, not a proof-of-harm standard.

How would I know if my manufacturer already filed one for an ingredient?

Ask for the notification's filing date and FDA docket number. FDA does not disclose a notification's existence for 90 days after filing; after that, filed notifications are searchable through FDA's public docket at regulations.gov, subject to trade-secret redactions.

Guide

What is an NDI notification, and when does a supplement need one?

By Jake, founder · Published 2026-08-17 · Updated 2026-08-17

A New Dietary Ingredient (NDI) is a dietary ingredient not marketed in a US dietary supplement before October 15, 1994. If it hasn't been present in the food supply in an unaltered form, the manufacturer or distributor must notify FDA at least 75 days before introducing it into interstate commerce, or the product is adulterated.

What counts as a new dietary ingredient

The Federal Food, Drug, and Cosmetic Act 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” (21 U.S.C. 350b(d)). FDA's guidance is explicit that there is no official list to check against: “There is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994. Therefore, manufacturers and distributors… are responsible for determining if an ingredient is a ‘new dietary ingredient’ and, if not, for documenting either that a dietary supplement that contained the dietary ingredient was marketed before October 15, 1994, or that the dietary ingredient was marketed for use in dietary supplements before that date.”

A novel form of an old ingredient can still be new. If a dietary ingredient “has not been present in the food supply as an article used for food in the same chemical form that you plan to use in your dietary supplement, you must show why you consider that the new dietary ingredient will reasonably be expected to be safe”. A different extraction method, concentration, or synthesis route can put a familiar-sounding ingredient back into NDI territory even if a version of it has been sold for decades.

The 75-day premarket notification

FDA's guidance states the trigger directly: a dietary supplement containing an NDI is adulterated under section 402(f) of the Act unless it meets one of two conditions: the ingredient has been present in the food supply as an article used for food, unaltered; or “at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.”

The consequence of skipping it is stated without qualification: “if a notification is required for a product containing a new dietary ingredient and the product is marketed without the required notification, the product is adulterated as a matter of law.” Whether the ingredient is actually safe is beside the point. The missing filing itself is the violation.

Who has to file

FDA's guidance lists four categories of required filer: “manufacturer who intends to market a new dietary ingredient; manufacturer who intends to market a dietary supplement that contains a new dietary ingredient; distributor who intends to market a new dietary ingredient; or distributor who intends to market a dietary supplement that contains a new dietary ingredient.” A brand owner that markets a finished supplement containing an NDI is a distributor within that list, so the filing obligation is not limited to whoever physically manufactures the ingredient.

The regulation implementing this, 21 CFR 190.6, requires the notification to be submitted to FDA's Office of Dietary Supplement Programs and specifies what it must contain:

Required contents of an NDI premarket notification, 21 CFR 190.6(b)
Element	What it requires
Filer identity	Name and complete address of the manufacturer or distributor.
Ingredient identity	Name of the new dietary ingredient, including the Latin binomial (with author) for any herb or botanical.
Product description	The level of the NDI in the supplement, and its recommended or ordinary conditions of use.
Safety basis	History of use or other evidence of safety, with citations to published articles accompanied by reprints or copies; foreign-language material needs an English translation.
Signature	Signature of the person designated as responsible for the notification's content.

What to ask a manufacturer

Because either party can file, and FDA does not maintain a simple public checklist you can search by ingredient name before the 90-day disclosure window closes, the practical risk is two parties each assuming the other filed, and neither did.

For each ingredient in your formula not obviously pre-1994, ask directly: has an NDI notification been filed for this ingredient in this form, by whom, and on what date?
Ask for the FDA docket number or acknowledgment, not just a verbal confirmation. Filed notifications become searchable through FDA's Dockets Management Staff and regulations.gov after the 90-day non-disclosure window.
If the ingredient is claimed to predate October 15, 1994, ask what documentation supports that. A marketing date claim without contemporaneous evidence is exactly the gap FDA's guidance flags.
If a chemically altered or newly concentrated form of a familiar ingredient is involved, don't assume the old ingredient's history covers the new form. The safety basis has to match the actual form used in your product.

This article does not determine whether your specific product would pass a review. It explains what the notification requirement is and where the citation lives.
An NDI notification is not the same as a structure/function claim notification. They go to the same office but serve different purposes and have different timing.

Related: 21 CFR Part 111 explained for brand owners and choosing a contract manufacturer: compliance questions. Compliant Always's free check tracks which documents you have on file for a SKU; it does not search FDA's NDI docket for you.

Sources

Frequently asked questions

What makes an ingredient a 'new dietary ingredient'?: One not marketed in a dietary supplement in the US before October 15, 1994, under 21 U.S.C. 350b(d). There is no authoritative FDA list of what was marketed before that date, so the manufacturer or distributor is responsible for determining this and documenting evidence either way.
Does every NDI require a notification?: Not if the ingredient has been present in the food supply as an article used for food, in a form where the food hasn't been chemically altered. If it hasn't, a notification is required unless the ingredient falls outside that carve-out for some other documented reason.
Who is required to submit the notification, me or my manufacturer?: Either a manufacturer or a distributor can file, and FDA's guidance lists both a firm intending to market the NDI itself and a firm intending to market a supplement containing it as required filers. In practice, whoever controls the safety information typically files, but the brand owner should confirm one specific party has, rather than assume the other did.
What happens if a required notification was never filed?: FDA states plainly: if a notification is required and the product is marketed without it, the product is adulterated as a matter of law, regardless of whether the ingredient is actually unsafe. It is a paperwork trigger, not a proof-of-harm standard.
How would I know if my manufacturer already filed one for an ingredient?: Ask for the notification's filing date and FDA docket number. FDA does not disclose a notification's existence for 90 days after filing; after that, filed notifications are searchable through FDA's public docket at regulations.gov, subject to trade-secret redactions.