Generally Recognized as Safe (GRAS) Determination Verification Services

GRAS determinations are governed under 21 CFR Part 170, specifically §170.30 and §170.35.

To verify and formally affirm that a substance used in a product is generally recognized as safe (GRAS) under the intended conditions of use, in alignment with FDA regulatory standards, without submitting a voluntary GRAS Notification to the FDA.

Scope of Work

The Company will perform third-party verification and affirmation of the client’s GRAS position. Services include:

1. Ingredient & Use Review

• Review of identity, specifications, manufacturing process, and intended use. • Confirm alignment with existing GRAS notices, scientific literature, or historical food use.

2. Toxicological & Safety Data Evaluation

• Evaluate available toxicological, clinical, and/or consumption data. • Assess against acceptable daily intake (ADI) and margin of exposure (MOE) if applicable.

3. Regulatory and Scientific Literature Search

• Conduct comprehensive searches to ensure the GRAS status is supported by generally available and accepted scientific information. • Confirm no conflicting evidence in peer-reviewed publications, EFSA/FDA reports, or monographs.

4. Expert Panel Consultation (Optional)

• Coordinate independent GRAS Panel if client elects to convene one. • Facilitate expert declarations and consensus documentation.

5. GRAS Determination Documentation

• Draft a GRAS Determination Report that includes:
- - Regulatory justification under 21 CFR §170.30(a)-(c), - Summary of data and safety conclusions, - Intended use and exposure estimates, - Bibliography and safety assessment rationale.
• Include an affirmation letter from the Company verifying that the GRAS status is consistent with FDA expectations.

6. Recordkeeping Support

• Advise on proper retention of GRAS files in case of future FDA inspection or retail inquiry.

Deliverables

• GRAS Determination Report and Affirmation Letter • Scientific Literature Review Summary (if applicable) • Bibliographic Data/Reference Table

Fees

Starting at $750.00 per ingredient Purchase

• For common ingredients with existing GRAS notices or widespread food use. • Includes document review, safety data interpretation, and preparation of an internal GRAS affirmation letter.

Custom Quote for Complex Ingredients

• Novel ingredients, botanicals with multiple components, or ingredients with limited data may require extended review. In such cases, a customized quote will be provided after a short intake assessment.

Estimated Timeline

• 15 to 25 business days from receipt of all necessary documentation.