New Dietary Ingredient (NDI) Notification: What US Buyers of Indian Herbal Ingredients Need to Know Before Launch

Q: What is a New Dietary Ingredient (NDI) and how do I know if my Indian herbal ingredient qualifies?

An NDI is a dietary ingredient that was not marketed in the United States as a dietary ingredient before October 15, 1994. If your Indian herbal ingredient supplier is offering a novel botanical, a new extraction process, a new solvent system, or a new part of a plant not previously used in US dietary supplements, it may qualify as an NDI even if the plant itself is well known. The test is not whether the plant existed before 1994, but whether that specific form of the dietary ingredient was marketed in the US food supply before that date without chemical alteration. Buyers should ask suppliers directly whether the ingredient, in the exact form being supplied, has documented US market history before 1994 or has already been the subject of an NDI notification.

Q: How long before launch does an NDI notification need to be filed with the FDA?

At least 75 days before the dietary supplement containing the new dietary ingredient is introduced or delivered for introduction into interstate commerce. The 75-day period is a review window, not a waiting period that guarantees approval - FDA can respond with an objection letter, a letter identifying deficiencies, or other regulatory concerns at any point within or after that window. The clock starts on the date FDA receives a complete notification, not the date it is mailed or submitted. If a manufacturer submits additional information that FDA determines to be a substantive amendment, the agency assigns a new filing date and the 75-day period restarts from that date.

Q: Who is responsible for filing the NDI notification - the Indian supplier or the US brand?

Either the manufacturer or distributor of the NDI itself, or the manufacturer or distributor of the finished dietary supplement containing the NDI, can file the notification. In practice, US brands launching a finished supplement most often file the NDIN themselves or through a regulatory consultant, since they hold the finished product safety and marketing claims. However, an Indian ingredient supplier who wants to make an ingredient available to multiple US customers without each customer filing separately can file the NDIN once for the ingredient itself, which then benefits any US brand sourcing that same ingredient in the same form and conditions of use. Buyers should ask suppliers whether an NDIN already exists for the specific ingredient and form being offered before assuming they need to file their own.

Q: What happens if a supplement is launched without a required NDI notification?

A dietary supplement containing an NDI that required notification, where no notification was filed or the filing was incomplete, is deemed adulterated under the Federal Food, Drug, and Cosmetic Act. This is a strict liability standard - it applies regardless of whether the ingredient is actually safe. Consequences can include FDA warning letters, import refusals at US ports for ingredients or finished products manufactured abroad, product seizure, and in some cases criminal exposure under the FD&C Act. Because the adulteration standard is independent of actual safety, a supplier or brand cannot cure the violation by pointing to a clean safety record after the fact - the notification has to exist before market introduction.

Q: Can I check whether an ingredient already has a filed NDI notification before starting the process myself?

Yes. FDA maintains a public list of submitted 75-day premarket notifications for new dietary ingredients, searchable by ingredient name, submitting firm, submission date, and FDA response date, available for download from FDA's website. Checking this list before commissioning new safety documentation can save significant time and cost if a prior notification already covers the ingredient in a comparable form - though buyers should note that an NDIN filed by one company for one specific form, extraction process, or conditions of use does not automatically extend to a different form of the same botanical, so the match needs to be assessed on the specific ingredient specification, not just the plant name.

A US supplement brand can have a fully executed supply agreement, a GMP-certified Indian manufacturer, a clean Certificate of Analysis, and a validated Bill of Lading - and still be legally barred from launching, because nobody checked whether the ingredient required a New Dietary Ingredient notification. Unlike Prior Notice, which is a per-shipment filing that clears a specific consignment through a specific port, the NDI notification is a business-level, ingredient-level requirement that determines whether a product can be marketed in the United States at all. Missing it does not delay a shipment - it makes the finished product adulterated by legal definition, independent of whether the ingredient is actually safe.

This guide is a companion to our FDA Prior Notice filing guide and our US FDA and DSHEA compliance guide. Prior Notice and NDI notification are frequently confused because both involve advance filing with FDA - they are unrelated requirements addressing different questions, and a compliant Prior Notice filing has no bearing on whether an ingredient also needed an NDI notification.

Direct Answer: What an NDI Notification Is and When It Applies

Under Section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the manufacturer or distributor of a new dietary ingredient - or of a dietary supplement containing that ingredient - must submit a premarket safety notification to FDA at least 75 days before the ingredient or the supplement containing it is introduced into interstate commerce. A New Dietary Ingredient is defined, under 21 CFR Part 190 Subpart B, as a dietary ingredient that was not present in the US food supply as an article used for food, in an unaltered chemical form, before October 15, 1994.

The requirement does not apply if the ingredient has been present in the US food supply in that unaltered form since before that date. This is where many Indian herbal ingredient sourcing decisions run into ambiguity: the underlying plant may have centuries of documented use in India, but if the specific form being supplied - a particular extraction method, a novel solvent system, a standardized fraction not previously marketed in the US, or a plant part not historically used as a US food or supplement ingredient - was not part of the pre-1994 US food supply, an NDI notification is required regardless of the plant’s traditional use history elsewhere.

What Counts as “New” - the Question Buyers Consistently Underestimate

The most common misjudgment in this area is treating “new dietary ingredient” as synonymous with “unfamiliar plant.” It is not. The regulatory question is narrower and more specific than that.

A well-known plant can still trigger NDI status. If an Indian supplier offers a novel proprietary extract of a common botanical - a new standardization ratio, a new extraction solvent, or a fraction isolated using a process not previously used to produce dietary ingredients marketed in the US - that specific ingredient form can be an NDI even though the plant species itself is unremarkable and has other, non-NDI forms already on the US market.

Chemical alteration is the trigger, not novelty of the source plant. The regulatory test asks whether the dietary ingredient, in the specific form being supplied, was present in the food supply before October 15, 1994, “in a form in which the food has not been chemically altered.” A traditional botanical powder produced by simple drying and grinding is unlikely to be considered chemically altered. A standardized extract produced through a specific solvent extraction and concentration process is a different question, and the answer depends on whether that same extraction approach and resulting composition already had pre-1994 US market history.

Different suppliers offering “the same” ingredient may not be interchangeable for NDI purposes. An NDI notification filed for one supplier’s ashwagandha root extract, at a specific withanolide standardization and produced by a specific process, does not automatically cover a different Indian supplier’s extract of the same plant produced with a different solvent, different standardization level, or different plant part. Buyers assuming that because “ashwagandha extract” has been notified before, any ashwagandha extract is covered, are working from a false equivalence that FDA does not recognize.

Practical questions to put to an Indian supplier before committing to a new ingredient:

Has this specific ingredient, in this specific form, been the subject of a prior NDI notification, by this supplier or any other party?
What is the documented history of this ingredient’s use in the US food supply, if any, before October 15, 1994?
What extraction or processing method is used, and has that same method been used to produce ingredients with documented pre-1994 US market presence?
If the ingredient is a novel extract or fraction, does the supplier have or have access to the toxicological and safety data an NDIN would require?

Evaluating whether a new botanical ingredient from an Indian supplier needs an NDI notification before US launch? Ayris Global works with suppliers who can document ingredient history, extraction methods, and prior regulatory filings - the information a regulatory affairs team needs to make that determination early, before a sourcing commitment is made. Contact our sourcing team

The 75-Day Filing Window and What Happens During It

The notification must reach FDA’s Office of Dietary Supplement Programs at least 75 days before the product is introduced into interstate commerce. Several mechanics of this window matter more than the headline number:

The clock starts on receipt of a complete notification, not on submission. An incomplete notification does not start the 75-day period. FDA can respond with a letter identifying deficiencies, which means the filer has to correct and resubmit, restarting the clock from the date of the corrected submission.

Substantive amendments reset the filing date. If FDA determines that additional information submitted during review is a substantive amendment rather than a minor clarification, the agency assigns a new filing date - the date it received the substantive amendment - and the 75-day period restarts from that new date. This means a notification submitted 75 days before a planned launch, that receives an FDA request for substantive additional data with 20 days remaining, can push the actual clearance date well past the original launch target.

FDA’s response is not an approval. Unlike some premarket clearance processes, FDA does not issue an approval letter for an NDIN. If FDA has no objection after review, the notifier may proceed to market once 75 days have elapsed from the filing date, without a formal green light. If FDA does object - through a deficiency letter, an objection to the adequacy of the safety data, or another regulatory concern - the ingredient should not be marketed until those concerns are resolved, even though the 75-day period may have technically elapsed.

Confidentiality has a limited window. FDA will not disclose the existence of or the contents of an NDI notification for 90 days after the filing date. After that period, notifications become part of FDA’s public disclosure record, which is also why the searchable list of past NDINs is a useful due diligence tool for buyers evaluating a new ingredient - a competitor’s or a supplier’s prior filing history for the same or a similar ingredient may already be public.

What an NDI Notification Must Contain

The notification is a safety dossier, not a form. At minimum, under 21 CFR 190.6(b), it must include:

The name and complete address of the manufacturer or distributor filing the notification
The name of the new dietary ingredient, including the Latin binomial name and authority for any herb or botanical
A description of the dietary supplement(s) containing the ingredient, including the level of the NDI in the supplement and the recommended or ordinary conditions of use
The history of use or other evidence of safety establishing that the ingredient, used as recommended, will reasonably be expected to be safe, including citations to published literature supporting that conclusion

For herbal ingredients specifically, this typically means assembling documented traditional use history (where applicable and where it genuinely supports the specific form being supplied), published toxicological and safety literature for the ingredient and, where relevant, for structurally or pharmacologically related compounds, manufacturing process documentation showing what the ingredient actually is at a chemical and physical level, and a clear specification of the identity, purity, and composition of the ingredient as supplied. Real notifications for botanical extracts sourced from Indian manufacturers - proprietary pine bark and other proprietary plant extract notifications appear on FDA’s public NDIN list - illustrate that Indian-manufactured ingredients do successfully clear this process when the underlying safety dossier is built properly; the process is demanding, not impossible.

NDI Notification vs. Prior Notice: Two Different Filings, Often Confused

Buyers new to US import compliance frequently assume that satisfying one FDA filing requirement covers the other. It does not.

NDI notification is a one-time, ingredient-level, business-decision filing that determines whether a specific new ingredient can legally be marketed in dietary supplements in the US at all. It is filed once per ingredient (in a given form and conditions of use), well before any shipment is planned, and its absence makes the finished product legally adulterated regardless of shipment-level compliance.

Prior Notice is a recurring, per-shipment, per-product-article filing required before each individual shipment physically arrives at a US port of entry, governed by an entirely separate statute - the 2002 Bioterrorism Act rather than DSHEA’s Section 413. A shipment can have a perfectly filed Prior Notice and still involve a product that required, and never received, an NDI notification. Conversely, an ingredient with a long-cleared NDI notification still requires Prior Notice for every individual shipment.

Buyers should treat these as two separate compliance checklist items evaluated at two different points in the sourcing relationship: NDI status at the point of ingredient selection, before committing to a new botanical or a novel extract form, and Prior Notice at the point of each shipment’s logistics planning.

A Practical Sequence for Evaluating a New Indian Herbal Ingredient

Identify the exact form of the ingredient - plant part, extraction method, solvent, standardization level - not just the plant species.
Check FDA’s public NDIN list for prior notifications covering that ingredient, that supplier, or a comparable form and process.
Ask the supplier directly whether they or any other party has filed an NDIN for this specific ingredient form, and request any documentation they can share.
If no prior notification exists and pre-1994 US market history cannot be documented, budget for an NDIN filing as part of the launch timeline - the 75-day minimum window should be treated as a floor, not a target, given how substantive amendments can extend it.
Engage a regulatory consultant experienced in botanical NDINs early, since assembling a defensible safety dossier for a botanical extract - particularly one involving traditional use claims - is a specialized undertaking distinct from general dietary supplement regulatory work.
Do not conflate NDI clearance with Prior Notice - both remain independently required once the ingredient is cleared to market and shipments begin.

Summary

An NDI notification is required at least 75 days before a dietary supplement containing a genuinely new dietary ingredient - one whose specific form was not part of the pre-October 1994 US food supply - is introduced into interstate commerce. The requirement applies at the level of the specific ingredient form, not the source plant, meaning a familiar Indian botanical can still require notification if the extraction method, standardization, or plant part represents something not previously marketed in the US. Failure to file makes the finished product adulterated as a matter of law, independent of actual safety. This is a separate, business-level requirement from the per-shipment Prior Notice filing, and buyers evaluating a new Indian herbal ingredient should check NDI status at the point of ingredient selection, well before any shipment is planned.

Frequently Asked Questions

What is a New Dietary Ingredient (NDI) and how do I know if my Indian herbal ingredient qualifies?

An NDI is a dietary ingredient not marketed in the US as a dietary ingredient before October 15, 1994. The test is whether the specific form being supplied - not just the source plant - had unaltered pre-1994 US market presence. A novel extraction process, standardization, or plant part can trigger NDI status even for a well-known botanical.

How long before launch does an NDI notification need to be filed with the FDA?

At least 75 days before market introduction. The clock starts when FDA receives a complete notification, and substantive amendments during review reset the filing date, which can push the effective timeline well past 75 days.

Who is responsible for filing the NDI notification - the Indian supplier or the US brand?

Either the ingredient manufacturer/distributor or the finished-supplement manufacturer/distributor can file. An Indian supplier filing once for an ingredient can cover multiple US buyers sourcing that same ingredient in the same form.

What happens if a supplement is launched without a required NDI notification?

The product is deemed adulterated under the FD&C Act as a strict liability matter, regardless of actual safety. Consequences include warning letters, import refusals, seizure, and potential criminal exposure.

Can I check whether an ingredient already has a filed NDI notification before starting the process myself?

Yes. FDA maintains a public, searchable list of submitted 75-day premarket notifications. A match needs to be assessed against the specific ingredient form and conditions of use, not just the plant name.

Further Reading: FDA Prior Notice for Herbal Ingredient Imports | US FDA and DSHEA Requirements for Importing Herbal Ingredients from India | How to Qualify and Audit an Indian Ayurvedic Ingredient Supplier

Ayris Global connects US supplement brands with Indian herbal ingredient suppliers who can document ingredient history, manufacturing process, and prior regulatory filings needed to evaluate NDI status before a sourcing commitment. To discuss a specific ingredient, contact our team at sourcing@ayrisglobal.in or visit our For Buyers page.