What qualifies as a New Dietary Ingredient (NDI)?

An NDI is an ingredient that: • Was not marketed in the U.S. before October 15, 1994 • Has not been included in the FDA’s recognized ingredient lists • Requires 75-day notification to the FDA before being sold in dietary supplements

What is GRAS (Generally Recognized as Safe) status?

GRAS status means that a substance is: • Generally Recognized as Safe under conditions of intended use • Supported by scientific data and qualified expert consensus • Eligible for self-determination or formal FDA notification

What happens if I don’t submit an NDI notification?

• The FDA may refuse importation of your dietary supplement. • You may face product recalls, warning letters, and legal penalties. • We ensure timely and compliant submissions to avoid these risks.

How long does the NDI notification process take?

• The FDA review period for NDI notifications is 75 days after submission. • The overall timeline depends on data collection, testing, and dossier preparation.

How is GRAS status determined?

GRAS status is established through: • Scientific studies demonstrating ingredient safety • Historical data on consumption and traditional use • Toxicological evaluations and risk assessments

Can ingredients be both NDI and GRAS?

• Yes, if the ingredient serves dual functions (as a dietary ingredient and food additive). • We help determine appropriate submission pathways for each scenario.

NDI & GRAS Review for Dietary Supplements

Overview

Service overview

We assess whether your ingredients are New Dietary Ingredients, prepare and submit NDI notifications, and evaluate GRAS status using scientific and toxicological evidence.

Product documentation being reviewed for compliance

Why this service matters

The FDA regulates dietary supplement ingredients to protect consumer safety.
A New Dietary Ingredient needs FDA notification at least 75 days before marketing.
Non-compliance can lead to import detentions, refusals, recalls and enforcement action.

New Dietary Ingredient (NDI) Assessment

We help you determine whether your ingredient is a New Dietary Ingredient (NDI) that needs a notification to the FDA.

Ingredient classification to determine NDI status
Regulatory risk assessments for novel dietary ingredients
Documentation review for existing approvals or exemptions

Export-ready goods prepared inside a warehouse — Dietary Supplements
New Dietary Ingredient (NDI) & GRAS Review

NDI Notification Preparation & Submission

An NDI notification must be submitted to the FDA at least 75 days before the product is marketed, and we handle the whole submission.

Formal submission to the FDA and management of FDA enquiries
Compilation of safety data, toxicology reports, and clinical studies
Preparation of comprehensive NDI notifications as per 21 CFR 190.6

GRAS (Generally Recognized as Safe) Determination & Review

GRAS status matters for food additives and ingredients used in supplements, and we carry out scientific evaluations against GRAS criteria.

Ingredient safety assessments based on scientific data
Literature reviews and toxicological evaluations
Preparation of GRAS self-determination dossiers

Ingredient Safety & Toxicology Reviews

The FDA expects robust safety data for new ingredients, so we coordinate third-party laboratory work and scientific reviews.

Toxicological evaluations for potential health risks
Clinical study reviews and expert data analysis
Safety profile documentation for FDA submission

Scientific Literature & Historical Use Analysis

We review the scientific literature and compare global regulatory positions to demonstrate an ingredient's safety and history of use.

Review of published scientific studies related to ingredient safety
Assessment of traditional and historical ingredient use
Comparison with international regulatory approvals

Regulatory Strategy & Compliance Consultation

Our experts provide tailored regulatory guidance on meeting US market requirements for your ingredients.

Strategic planning for ingredient approval pathways
Ongoing regulatory updates relevant to dietary supplements
Post-submission support for FDA feedback and responses

Ongoing compliance support

Time-Saving
We compile the safety data and documentation, so your team can focus on product development.
Regulatory Assurance
Ingredient status assessed against NDI and GRAS requirements before you go to market.
Peace of Mind
Reduce the risk of detentions, refusals and enforcement action over ingredient compliance.

What you'll need

Ingredient reviews rely on evidence, so collect what already exists.

Ingredient identityEnough detail to classify NDI status.
Safety and toxicology dataStudies and reports on the ingredient.
History of useEvidence of traditional or historical use.
Existing approvalsAny exemptions or approvals already in place.

New Dietary Ingredient (NDI) & GRAS Review