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GRAS, NDI and Safety Assessments

powder capsules Kurtis GarbuttGRAS, NDI and Safety Assessments

The objective of the safety assessments required by NDI (New Dietary Ingredient) and GRAS (Generally Recognized as Safe)  for supplements and foods is to provide a baseline evaluation of the safety aspects of an ingredient.

FDA issued new draft guidance on the NDI requirement in August 2016, in addition to final guidance on GRAS requirements which includes a new voluntary notification process.  The guidances renew and clarify an established requirement that requires a significant amount of information related to safety and quality of dietary ingredients to be compiled and evaluated by scientific experts.

In response to the high demand for NDI notification dossiers, a pre-assessment can be quickly conducted to determine the appropriate strategy and level of risk.  Contact us to determine the best strategy for you.

Here is a framework of basic requirements for a safety assessment

  1. Clinical, Medicinal and Food Use 
    1. In country to market
    2. Global
  2. Regulatory Status
    1. ODI or NDI (if ingredient used for supplement)
    2. GRAS
    3. Other
  3. Toxicity Summary
    1. History of human consumption in foods/supplements including dosage amount and composition
    2. LD50/acute toxicity/chronic/subchronic toxicity studies
    3. Bioavailability and ADME
    4. Clinical trials
    5. Other (genotoxicity, carcinogenicity, reproductive toxicity etc)
    6. Case reports, AER and Drug Interaction Review
  4. Dietary Supplement Manufacturing Risk Review (or CMC, Chemistry/Manufacturing/Control)

    1. Chemical and Nutritional Characterization
      1. Literature review
      2. Specification, Certificate of Analysis, ID and contaminants
    2. Manufacturing Facility GMP evaluation (self-assessment and audits)
    3. Potential adulterants and their controls

Contact us for more information.