Generally Recognized as Safe (GRAS) Determination Verification Services
Ensuring GRAS compliance in line with 21 CFR Part 170, your path to safe and lawful market entry
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
- • Verify the full ingredient name, source material, and specification sheets. • Confirm CAS number, processing method, and chemical structure (if applicable). • Assess intended use level and target consumer population.
2. Manufacturing Process and Purity Verification
- • Review process descriptions to determine if identity, composition, or safety is affected (e.g., hydrolysis, extraction). • Evaluate the source and origin to assess potential risks (e.g., marine species for collagen). • Assess for potential contaminants or adulteration risks based on process and origin.
3. Regulatory and Scientific Literature Evaluation
- • Verify the ingredient’s U.S. regulatory status (GRAS-listed, DSHEA-compliant, or NDI-subjected). • Conduct scientific literature search for toxicological, clinical, or consumption data to confirm safety under intended use. • Evaluate against FDA-established intake limits (e.g., DV, UL, RDI) and determine allergenicity risks where applicable. • Check for prior GRAS Notices, EFSA opinions, or other authoritative listings.
4. Gap Analysis and Risk Identification
- • Identify missing documentation, data gaps, or potential compliance risks that may impact GRAS status affirmation.
5. GRAS Determination Documentation
- • Draft a GRAS Determination Report that includes:
- - Regulatory justification under 21 CFR §170.30(a)-(c), - Summary of findings and regulatory conclusions - Identified data gaps or further recommendations - Supporting references (regulations, scientific studies, or official listings
6. Recordkeeping Support
- • Advise on proper retention of GRAS files in case of future FDA inspection or retail inquiry.
Deliverables
• GRAS Ingredient Regulatory Status Summary Report (per ingredient)
• List of additional recommendations (if any)
• Reference and bibliography summary (scientific literature, FDA sources)
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/Multiple 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 an initial assessment.
Estimated Timeline
- • Per ingredient: 10 to 25 business days from receipt of all necessary documentation.
Disclaimer
- Services provide assessment and/or submission facilitation based on the available documentation to facilitate compliance per applicable regulations, but does not constitute assured regulatory approval, nor does it guarantee market acceptance, regulatory clearance, or product sales in the target market.