The objective of NDI and GRAS for supplements and foods is to provide a baseline evaluation of the safety aspects of an ingredient.
FDA issued draft guidance on the NDI and final guidance on the updated GRAS requirement in August 2016. The guidances are likely to require a significant amount of information related to safety and quality of dietary ingredients to be compiled and evaluated by scientific experts.
Four Steps to Compliance:
A pre-assessment is typically conducted quickly to determine the appropriate strategy and level of risk. Contact us to determine the best strategy for you.
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For more detail, here is a framework of basic requirements for a safety assessment
- Clinical, Medicinal and Food Use
- In country to market
- Global
- Regulatory Status
- ODI or NDI (if ingredient used for supplement)
- GRAS
- Other
- Toxicity Summary
- History of human consumption in foods/supplements including dosage amount and composition
- LD50/acute toxicity/chronic/subchronic toxicity studies
- Bioavailability and ADME
- Clinical trials
- Other (genotoxicity, carcinogenicity, reproductive toxicity etc)
- Case reports, AER and Drug Interaction Review
- Dietary Supplement Manufacturing Risk Review (or CMC, Chemistry/Manufacturing/Control)
- Chemical and Nutritional Characterization
- Literature review
- Specification, Certificate of Analysis, ID and contaminants
- Manufacturing Facility GMP evaluation (self-assessment and audits)
- Potential adulterants and their controls
- Chemical and Nutritional Characterization
Contact us for more information.