New Dietary Ingredient Notification

New Ingredient Notification: Preparation & Submission to the FDA

A complete compliance guide for nutraceutical, dietary supplement, and food ingredient manufacturers — and how JJCC Group helps you meet every FDA requirement.

Bringing a new ingredient to market in a regulated industry is one of the most consequential — and most scrutinized — steps a manufacturer, distributor, or brand owner can take. Before a novel substance can lawfully enter interstate commerce in a dietary supplement, conventional food, or food-contact application, the U.S. Food and Drug Administration (FDA) expects to be informed, and in many cases must affirmatively review the safety basis for that ingredient. Getting this wrong can mean import refusals, warning letters, product seizures, and costly recalls. Getting it right requires a disciplined, evidence-driven submission built on the correct regulatory pathway. J&J Compliance Consulting Group (JJCC Group) prepares, assembles, and manages New Ingredient Notifications end-to-end, so your launch stays on schedule and on the right side of the law.

This page explains what a New Ingredient Notification is, which 21 CFR regulations govern each industry, who is legally responsible for filing, exactly what the notification must contain section by section, what counts as a “new ingredient,” and how JJCC Group delivers each piece of the package.

When your ingredient is new to FDA

A new dietary ingredient (NDI) is one not marketed in the U.S. as a dietary supplement before Oct 15, 1994. Unless an exception applies, the manufacturer or distributor must notify FDA at least 75 days before the NDI enters interstate commerce. The notification must show the NDI is reasonably expected to be safe under the proposed conditions of use. JJCC Group prepares and files the notification with our toxicologists.

FDA does not approve NDIs. It acknowledges the notification, with or without objection.

Situation	NDIN needed?	Governing 21 CFR
Marketed as a dietary supplement before Oct 15, 1994	No, with evidence of that marketing	21 CFR 190.6 (FD&C Act § 413); 21 CFR Part 111 (cGMP)
Present in the food supply as an article used for food, in a form not chemically altered	No	21 CFR Part 170, Subpart E (170.30, 170.36)
New ingredient, or old ingredient chemically altered	Yes	21 CFR 171.1; safety standard 21 CFR 170.3
Same NDI already notified by another firm	Usually yes, unless the prior notice covers your identity and conditions of use	21 CFR Part 71 (FD&C Act § 721)
Ingredient for conventional food, not supplements	No NDIN; use GRAS or a food additive petition	21 CFR Part 170, Subpart D (170.100–170.106)

Note: medical devices and pharmaceuticals follow entirely separate regimes (21 CFR Parts 210/211 for drugs, 820 for device quality systems, ISO 13485 for device QMS). JJCC Group advises across all of these, but “New Ingredient Notification” in the FDA sense centers on the food and supplement pathways above.

Nutraceuticals & Dietary Supplements: The NDIN (21 CFR 190.6)

Under section 413 of the Federal Food, Drug, and Cosmetic Act, a manufacturer or distributor must notify FDA at least 75 days before introducing into interstate commerce a dietary supplement that contains a new dietary ingredient (NDI) — one not present in the food supply as an article used for food in a form that has not been chemically altered. The procedural rule lives at 21 CFR 190.6. The notification goes to the Office of Dietary Supplement Programs (HFS-810), CFSAN, in College Park, Maryland.

The 75-day clock begins on FDA’s filing date (the date of receipt), and the agency will not disclose the existence of the notification for 90 days after filing. If the notifier submits a substantive amendment during review, FDA may reset the clock with a new filing date.

What is a “new dietary ingredient”?

A dietary ingredient is “new” if it was not marketed in the United States in a dietary supplement before October 15, 1994. The following typically trigger an NDIN:

Novel botanicals, extracts, or concentrates not previously sold in supplements before the cutoff date.
Synthetic or fermentation-derived versions of an ingredient where the manufacturing process chemically alters the substance.
New combinations, higher potencies, or new dosage forms that change identity or exposure.
Ingredients used previously in food but now chemically altered for supplement use.

When an NDIN is NOT required

Determining grandfathered status is a frequent point of dispute with FDA. JJCC Group builds the documentary record to support the chosen position before you commit to it.

Food & Beverage Ingredients: GRAS and Food Additive Routes

If the same ingredient is intended for a conventional food or beverage rather than a supplement, the NDIN does not apply. Instead, the substance must either be the subject of an approved Food Additive Petition under 21 CFR 171.1, or qualify as Generally Recognized as Safe (GRAS).

GRAS Notification — 21 CFR Part 170, Subpart E

GRAS status can be established through scientific procedures (21 CFR 170.30(b) — the same quantity and quality of evidence needed for food-additive approval, generally published studies) or, rarely, through common use in food before 1958 (21 CFR 170.30(c) and 170.3(f)). The GRAS Notification program is voluntary: a notifier informs FDA’s Office of Food Additive Safety (HFS-200) of its independent conclusion, and FDA issues a “no questions” letter, a letter ceasing evaluation, or an objection.

Food Additive Petition — 21 CFR 171.1

When safety cannot be generally recognized, a full FAP is required. Under 21 CFR 171.1(c), the petition must establish identity and composition, intended use and use levels, the intended technical effect, validated analytical methodology, full reports of safety studies, proposed tolerances where applicable, and an environmental assessment. FDA — not outside experts — makes the safety determination here.

Who Is Responsible for Preparing and Submitting?

For an NDIN, 21 CFR 190.6(a) places the obligation on the manufacturer or distributor of either the dietary supplement that contains the NDI, or of the NDI itself. A key trap: an ingredient supplier’s NDIN does not automatically cover the finished-product company. Unless the supplier’s prior notification specifically described the finished supplement and its conditions of use, the supplement manufacturer or distributor must file its own NDIN. JJCC Group maps this responsibility chain early so no party assumes someone else has “already filed.”

Dietary supplements: the NDI manufacturer, the finished-supplement manufacturer, or the distributor — each may need to file depending on coverage.
GRAS / food additives: the ingredient sponsor, manufacturer, or an authorized agent may submit; agents commonly file on the client’s behalf.
Signatory: 21 CFR 190.6(b)(5) requires the signature of a person designated by the manufacturer or distributor.

JJCC Group can serve as your authorized agent and U.S. point of contact, coordinate signatures, and manage all correspondence with FDA throughout the review window.

What the Notification Includes

For an NDIN, 21 CFR 190.6(b) specifies the mandatory contents. JJCC Group prepares each of the following components and assembles them into an FDA-ready dossier.

§	Required Element	How JJCC Group Delivers It
1	Name and address of the notifier.	We confirm the correct legal entity, designate the responsible signatory, and prepare a clean cover letter and administrative cover sheet.
2	Name of the NDI and, for botanicals, the Latin binomial and plant part.	We characterize the ingredient — specifications, identity testing, part of plant used, extraction solvent and ratio — and apply correct nomenclature so FDA can unambiguously identify the substance.
3	A description of the supplement: level of the NDI, conditions of use and the recommended serving.	We document the finished-product formula, serving size, target population, and labeled conditions of use, and align the dossier to your intended marketing claims.
4	The history of use or other evidence of safety, with full copies of cited references.	We construct the safety narrative: literature review, history-of-use evidence, toxicology data, exposure assessment, and a margin-of-safety analysis — and supply full-text copies of every reference, as the regulation requires.
5	Identity, composition and manufacturing information, based on FDA's recommendations.	We coordinate the authorized signature and submit an original plus the required copies (or the accepted electronic format) to HFS-810.

For GRAS notices, the parallel structure under 21 CFR Part 170 Subpart E includes the GRAS exemption claim, identity and method of manufacture, dietary exposure, self-limiting levels, and the basis for the GRAS conclusion supported by a published safety dossier and, typically, an expert-panel consensus. JJCC Group builds the equivalent package and convenes or coordinates the qualified-expert panel where a scientific-procedures GRAS conclusion is used.

The JJCC Group New Ingredient Notification Program

Our service is structured so that every regulatory requirement maps to a concrete deliverable. We work within a cGMP-disciplined framework — SOPs, CAPA, validation, and data-integrity controls — so the evidence you submit is defensible and audit-ready.