The short answer
A new dietary ingredient (NDI) is a dietary ingredient that was not marketed in the United States as a dietary ingredient before October 15, 1994. If your supplement contains one, the manufacturer or distributor must usually file an NDI notification with FDA at least 75 days before the product is introduced into interstate commerce (21 CFR 190.6). The notification must explain why the supplement can reasonably be expected to be safe. FDA does not “approve” NDIs — it reviews the notification and may object.
In October 2026, FDA finalized the part of its NDI guidance that explains what identity and safety information it expects.
Why exporters should care
A supplement containing an NDI without the required notification can be considered adulterated. Newer botanical extracts, novel probiotics, synthetic versions of natural compounds and new forms of vitamins and minerals are the usual risk areas — especially for brands from India, China, South Korea and Europe selling on Amazon.
Is my ingredient an NDI?
Ask these questions in order:
- 1Is it a dietary ingredient at all?Vitamins, minerals, herbs or other botanicals, amino acids, dietary substances used to supplement the diet, and concentrates, metabolites, constituents, extracts or combinations of these.
- 2Was it marketed in the U.S. as a dietary ingredient before October 15, 1994?If you can document that (labels, catalogs, invoices from before that date), it is an “old” dietary ingredient and no NDI notification is needed. Industry lists of old ingredients exist, but FDA has not issued an official list.
- 3Has it been changed?A different extraction solvent, a much higher concentration or a new manufacturing process can make an old ingredient a new one.
- 4Is it already in the food supply in the same form?The law does not require a notification if the ingredient is only in supplements that contain dietary ingredients present in the food supply as articles used for food, in a form not chemically altered.
What goes into an NDI notification
FDA’s October 2026 final guidance on identity and safety recommends:
- Identity: composition, physical and chemical characteristics, manufacturing process, specifications, contaminants and impurities, and the analytical methods used. There is specific advice for botanicals, extracts and probiotics.
- Conditions of use: the daily serving, duration of use and target population, matching the planned label.
- History of use: evidence that people have consumed the ingredient safely. Where history of use is the only support, FDA suggests about 25 years of widespread use under comparable conditions.
- Other safety evidence: where history of use is not enough — for example genetic toxicity tests, animal studies or human studies. FDA says it takes a case-by-case approach and accepts alternative methods.
- A safety conclusion that ties the evidence to the planned conditions of use.
Parts of the guidance — when a notification is required, and master files — are still in draft.
How to submit
- Electronically through FDA’s Centralized Online Submission Module (COSM) — FDA’s preferred route, with a receipt and email status updates.
- On paper to FDA’s Office of Dietary Supplement Programs (original plus two copies).
- File at least 75 days before marketing. FDA charges no fee.
Who files? The manufacturer or distributor of the NDI or of the supplement containing it. Often the ingredient supplier files. A notification covers the ingredient described in it, made the way it describes, under the conditions of use it states — so if you buy a “similar” ingredient from a different supplier, or use a higher dose, do not assume someone else’s notification covers you.
Example: a botanical extract from India
A U.S. brand plans a capsule with a new, highly concentrated extract made by an Indian supplier using a new solvent process. The plant was sold in the U.S. before 1994, but only as a dried powder. The new extract is likely an NDI. Before launch, the supplier (or brand) should file an NDI notification with full identity data, the planned daily dose and the safety evidence, then wait at least 75 days.
NDI is not the only supplement rule
Even with an NDI notification, the product still needs: a registered manufacturing facility, a correct Supplement Facts label with lawful structure/function claims, cGMP compliance (21 CFR part 111), and — for imports — an FSVP by the U.S. importer.
FDA facility registration with U.S. Agent from $300. Supplement label review from $250. FSVP for your importer from $400.
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP agent service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
Frequently asked questions
What is the NDI cutoff date?
October 15, 1994. A dietary ingredient not marketed in the U.S. as a dietary ingredient before that date is a new dietary ingredient.
How long before launch must I file?
At least 75 days before the supplement is introduced or delivered for introduction into interstate commerce (21 CFR 190.6).
Does FDA approve new dietary ingredients?
No. FDA reviews the notification and may object if the safety information is inadequate. The responsibility for safety stays with the company.
Is there a fee for an NDI notification?
No. FDA does not charge a fee. The cost is in preparing the identity and safety data.
Sources
- FDA — How to submit notifications for a new dietary ingredient (updated August 27, 2026)
- NutraIngredients — FDA releases final NDI guidance on identity and safety (October 19, 2026)
- FDA — Dietary Supplement Labeling Guide, Chapter VII: Premarket notification for new dietary ingredients
Dates and requirements checked on November 11, 2026. This article is general information, not legal advice.