ODI, NDI, GRAS

Our Ingredient Regulatory Status Audits determine if an ingredient is an old dietary ingredient (ODI) or has to be approved by the Food and Drug Administration (NDI or GRAS notification depending on the case).

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Service details

Similar to our expertise in supporting successful novel food applications in Europe, we also audit of the regulatory status of ingredients for use in foods and/or dietary supplements in the US to define whether an ingredient is an old dietary ingredient (ODI) or has to be approved by the Food and Drug Administration. (NDI or GRAS notification depending on the case)

Methodology

  • Regulatory Status Review of the native ingredient before processing (plant, animal product, other source…), for use in foods and/or dietary supplements in the US
  • Regulatory Status Analysis of the processed ingredient (extract, powder, concentrate, etc.) depending on the process: extraction ratio, selectivity of active compounds, solvents, technological auxiliaries

Deliverable

  • An overview of the regulatory status of the native ingredient before processing in US
  • A detailed analysis of the status of the processed ingredient intended for marketing as per regulations and quality standards
  • Our recommendation for an optimized regulatory strategy, including a presentation of suitable procedures to achieve authorization for the marketing of the ingredient