NDI, GRAS and Supplement Safety Assessment

Bring your product or ingredient to market with a clear, defensible regulatory pathway.

If you supply a novel ingredient, botanical, or specialty compound for food or dietary supplements, you have one question that matters more than any other: **is this ingredient GRAS, is it a New Dietary Ingredient (NDI), or is it something else entirely?**

Getting that answer wrong is expensive.

Getting it right — with documentation that holds up to FDA scrutiny, retailer requirements, and increasingly aggressive plaintiffs’ attorneys — is what lets you actually sell your ingredient with confidence.

FDA’s regulatory landscape for GRAS and NDI status is under active change, with new rulemaking in August 2026 pushing toward mandatory GRAS notification and closer scrutiny of self-affirmed safety conclusions.

Suppliers who once relied on an internal “self-affirmed GRAS” determination are facing new pressure to document, notify, and defend that status formally.

NaturPro Scientific helps you get ahead of these new requirements.

Is Your Ingredient ODI, NDI, or GRAS?

Before you spend a dollar on studies, you need to know which category your ingredient falls into:

–ODI (Old Dietary Ingredient)** — marketed in the U.S. as a dietary supplement before October 15, 1994. No notification required.

— NDI (New Dietary Ingredient) — introduced after that date. Requires an NDI notification to FDA at least 75 days before marketing, unless the ingredient has been present in the food supply, unaltered, as an article used for food.

— GRAS (Generally Recognized as Safe) — appropriate when the ingredient is intended for conventional food use, or when a supplement ingredient’s food-use history can establish the NDI exemption above.

Getting this classification wrong at the outset is the single most common — and most expensive — mistake suppliers make.

Our Services

1. Gap Analysis

We review your existing safety and quality documentation — toxicology data, history of use, manufacturing records, specifications — against what FDA and current guidance actually require. You get a clear picture of what you already have, what’s missing, and what stands between your ingredient and a defensible market claim.

2. Regulatory Status Recommendation

Every ingredient needs a determined path: Old Dietary Ingredient (ODI), New Dietary Ingredient (NDI), GRAS, or another classification entirely. We evaluate your ingredient’s composition, history of use, and intended conditions of use to recommend the status that fits — and the strategy to support it.

3. Notification Assessment

Whether your ingredient needs an NDI notification, a GRAS notice, or qualifies for another route to market, we assess the requirements specific to your situation and help you understand the timeline, cost, and data package involved before you commit resources.

4. Dossier Preparation & FDA Submission

Once your path is set, we prepare and submit the full notification package — GRAS notice or NDI notification — including identity, manufacturing process, safety data, and conditions of use, and manage the submission through FDA’s review window (75 days for NDI notifications).

5. FDA Response Management

If FDA comes back with questions, requests additional information, or issues an objection, we manage that response on your behalf so a stalled submission doesn’t become a dead one.

6. Toxicology & Safety Study Design

When your existing literature has real gaps, such as in Good Laboratory Practices (GLP) or OECD Guidelines, we design and oversee the studies needed to fill them — from history-of-use documentation to targeted toxicology studies — rather than just flagging that a gap exists.

7. Label & Supplement Facts Review

A related compliance check most suppliers need anyway — we review labeling and Supplement Facts panels alongside your regulatory work.

How It Works: Four Steps to a Defensible Regulatory Position

1. Determine likely regulatory status.

A preliminary review of your ingredient’s toxicology profile, history of use, and intended use conditions to identify the most probable classification — ODI, NDI, GRAS, or other.

2. Compile your master file.

We help you assemble a complete safety and quality file — often well over a hundred pages with supporting references — aligned with current FDA guidance and 21 CFR 117.

3. Run the gap and risk analysis.

Your master file is reviewed against the regulatory status you’re pursuing. We identify gaps and assess the risk they pose to safety compliance, product quality, and brand exposure.

4. Chart your action plan.

You get a clear, prioritized plan — the studies, documentation, or notifications needed to close the gaps and move your ingredient to market on solid footing.

Why NDI and GRAS Are Important Now

Toxicology and safety studies are expensive. Before you commission them, you need to know exactly what your ingredient requires: a GRAS notification, an NDI notification, both, or neither.

Suppliers who skip this step risk being blindsided later — by FDA, by retail partners doing their own due diligence, or by class action attorneys looking for exactly this kind of gap.

A pre-assessment is typically fast and gives you a clear read on strategy and risk before you invest further.

What an Assessment Typically Covers

Clinical, Medicinal & Food Use:
– Use history in your target market
– Global use history

Regulatory Status
– ODI or NDI (for supplement ingredients)
– GRAS
– Other applicable pathways

Toxicity Summary
– History of human consumption in food/supplements, including dosage and composition
– LD50, acute, chronic, and subchronic toxicity data
– Bioavailability and ADME
– Clinical trial data
– Genotoxicity, carcinogenicity, and reproductive toxicity, where relevant
– Case reports, adverse event reports, and drug interaction review

Manufacturing Review (CMC)
– Chemical and nutritional characterization, including literature review and specifications/CoA
– Manufacturing facility GMP evaluation (self-assessment and audit-ready)
– Potential adulterants and their controls

Contact us for more information on GRAS and NDI Services.

NDI, GRAS and Supplement Safety Assessment