This service is part of our Scientific and Regulatory Expertise in health nutrition to help you design and launch your products in Europe, USA and Asia, through a panel of services : Novel Food consulting evaluation, Regulatory Compliance & notification, Health Claims, …
In the same way that we are working on the Novel Foods status for Europe, we are able to audit of the regulatory status of ingredient for use in foods and/or dietary supplements in the US, in order to define whether the ingredient is an old dietary ingredient (ODI) or has to be notified to the Food and Drug Administration (NDI or GRAS notification depending on the case).
Methodology
Review of the regulatory status of the native ingredient before processing (plant, animal product, other source…), for use in foods and/or dietary supplements, in the US
Analysis of the regulatory status of the processed ingredient (extract, powder, concentrate…) 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 U.S.
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.