NDI Notification: Does Your Ingredient Need One, and When?

An ingredient needs an NDI notification when it is a dietary ingredient, was not sold in the US before October 15, 1994, and was not present in the food supply as food in a form that has not been chemically altered. Work through these steps in order, following FDA's final guidance on notification procedures and timeframes (March 2024).

1. Is it a dietary ingredient? Pass: it fits the statutory definition (21 U.S.C. 321(ff)(1)) and goes on to step 2. Fail: it is a drug, a cosmetic, or another product outside the dietary supplement definition. Stop here, because this is not an NDI question and FDA treats it as a separate regulatory problem.
2. Do you hold dated records showing the same form was sold in the US before that date? Pass: dated sales or label records for the same form. No notification is needed. Fail: you have only an industry list of old ingredients, or the fact that competitors sell it. FDA's revised draft guidance (still a draft) says a listing is not sufficient evidence. A new salt, ester, extract ratio or process that alters the chemical composition may also make an old ingredient new, so go on to step 3.
3. Was it present in the food supply as an article used for food, in a form not chemically altered? Pass: you can document that. No notification is needed. Fail: notify FDA at least 75 days before interstate sale.

Most sellers never file. In its 2022 draft policy on late notifications, FDA estimated that more than 4,600 notifications should have been filed since 1994, against about 1,200 received as of May 2022. FDA's list now carries 1,460 numbered entries. That draft is not final policy. It does show that "nobody else files" is not evidence that nobody needs to.

Either the ingredient maker or the supplement maker may file. An ingredient maker's filing does not remove the supplement maker's duty unless the earlier notification also described the supplement, meaning its description and conditions of use. That is the position in FDA's final guidance.

A notification must contain your contact details, the identity of the ingredient (a Latin binomial for any botanical), a description of the supplement with its dose and intended use, the evidence that it is reasonably expected to be safe, English translations, full-text copies of every cited reference, and an authorized signature, as set out on FDA's how-to-submit page. An incomplete filing does not satisfy the requirement, and a product sold on one is adulterated. FDA does not evaluate safety or identity data in an incomplete notification.

Our recommendation: prepare the references and translations before you file, because day 0 is the date FDA receives the filing.

As of October 2026, FDA's guidance on the identity and safety information an NDI notification needs is still in draft. FDA lists a final version among its 2026 priority deliverables. Check FDA's dietary supplements guidance page for a final version before you file.

In the 2021 to 2024 entries we analyzed, FDA's response date fell a median of 66 days after submission, and 97% fell within 75 days. For 2025 submissions the median was 69 days, 83% fell within 75 days, and 12 of 71 ran past day 75, the longest at 123 days.

How we counted. We downloaded the spreadsheet on FDA's list of submitted notifications, which FDA states is current as of July 10, 2026. It has rows for 1,372 of the 1,460 numbered notifications, so 88 numbers have no row. Of those 1,372 rows, 2 have a submission date that cannot be read as a date and 2 have a response date earlier than the submission date. We dropped these 4, leaving 1,368 usable intervals. Of these, 334 (submitted 1995 to 2005) and 9 (submitted January 2026) are left out of the table, which leaves the 1,025 shown (489 + 282 + 183 + 71). For each entry we subtracted the submission date from the response date and grouped by submission year.

Every row has a response date, so none were treated as pending. The list carries reviewed notifications only, so a 2025 filing still awaiting a reply is absent, and the 2025 row may understate slow replies. The clock legally runs from the filing date (FDA's receipt), which may differ slightly from the submission date. The list shows dates only, not whether a reply was an objection.

Entries by submission year, counting rows with a readable submission date: 2017, 93; 2018, 42; 2019, 33; 2020, 54; 2021, 47; 2022, 33; 2023, 45; 2024, 59; 2025, 71.

The calendar to plan on:

• Day 0 is the date FDA receives the filing. You may not ship across state lines until 75 days have passed.
• The 75-day bar ends on day 75 even if FDA has not replied. Shipping before a reply carries the risk of a later objection, so decide in advance whether you will ship at day 76 or wait for the letter.
• A substantive addition to the filing resets the filing date and restarts the 75 days (FDA guidance).
• Our recommendation is to plan labels and first production around a reply near day 70, and to budget for the slower cases.

A "no objection" letter from FDA means its review found no reason to object to your basis for concluding the ingredient is reasonably expected to be safe. It is not approval. FDA's guidance says the letter is not an independent finding that the product is safe or not adulterated, and FDA can act later.

FDA's usual replies are an acknowledgement without objection, an incomplete-notification letter, an objection to the identity or safety information, and a letter raising other regulatory issues. Failure to respond is likewise not a finding of safety.

Two further points matter commercially:

• FDA keeps a notification confidential for 90 days after the filing date. After that, the notification and FDA's reply go on public display, except trade secrets and confidential commercial information. Mark what you consider confidential.
• Even a filed notification does not protect a product whose safety evidence does not hold up. The ingredient is adulterated unless its history of use or other evidence supports a reasonable expectation of safety.

FDA's list of submitted notifications tells you which ingredient names firms have notified, and when FDA replied. It cannot tell you who is exempt, or whether a notification covers your form. A name appearing is not a verdict on that name, and a name being absent does not make it an old ingredient.

We checked our own supplement catalogue against the list to show the limits. We matched the names of items on our supplement raw materials page to the notification names in the FDA spreadsheet (a name search, not a legal review). Among the 10 entries whose name contains "creatine":

Inositol-stabilized arginine silicate (sold as Nitrosigine) has 2 entries (2004, 2013).

Read the table as a prompt to ask, not as an answer. Firms sometimes notify out of caution. An ingredient that appears nowhere may be old, may be filed under a trade name, or may be new and unnotified. The only safe conclusion is to establish the status for the exact form you intend to use.

Ask five, and treat any fail as a reason to file your own notification or change supplier. They show whether the supplier's paperwork covers your product. Ask for answers in writing, together with the certificate of analysis (COA), the specification and the safety data sheet (SDS). Our guide to qualifying a nutraceutical raw material supplier covers the wider supplier checks.

Which notification number covers this exact ingredient?

Pass: a notification number from FDA's list, filed by the manufacturer or supplier, naming the same form as your material. Fail: "we have an NDI" with no number, or a number for a different salt, ester or extract.

Does that notification describe a supplement like mine?

Pass: it includes a supplement description with dose and conditions of use that fit your label. Fail: it covers the ingredient only, in which case you file your own.

Can you send FDA's reply letter?

Pass: the reply is on the public docket and is an acknowledgement without objection. Fail: the supplier cannot produce it, or the letter objects and the objection is unresolved.

Is the material I am buying made the way the notification describes?

Pass: your COA and specification match the identity and process in the filing. Fail: the source, process or form has changed since the filing.

If you say no notification is needed, what shows the ingredient was sold before the 1994 cutoff?

Pass: dated sales or label records for the same form. Fail: an industry list, or the fact that others sell it. Our note on bulk vitamin suppliers by origin and documentation shows what origin paperwork to request for vitamins.

We supply supplement raw materials to B2B buyers, and we list them on our supplement raw materials page. For a quote, send the item name and CAS number (the Chemical Abstracts Service registry number), quantity, destination, grade or purity, the documents you need, payment terms and Incoterms (the shipping terms).

We share the COA, specification and SDS where they apply. Evaluation quantities are available to qualified B2B buyers, with quantity and price confirmed product by product. Minimum order quantity and lead time are also confirmed per product in the quotation. For international commercial orders, payment is generally 100% advance by bank transfer unless agreed otherwise in writing. Prices are quoted on request.

We do not state NDI status for our supplement raw materials on our product page. Ask us for the exact form and any supporting documents we can share, and apply the five questions above to our answer. Whether your supplement needs a notification remains your decision as the brand.

Contact us, or reach our sales team on WhatsApp at +91 9899783330 or at sunil@aarisepharma.com.