GRAS & NDI Approvals
For companies seeking GRAS & NDI approval of nutraceuticals, dietary supplements, food ingredients and herbal medicines in the USA, there are several different paths in which companies can seek approval.
Generally Regarded as Safe - GRAS approvals & GRAS notifications
Any substance that is intentionally added to food is a food additive and therefore subject to premarket approval by the FDA unless the substance is "Generally Regarded As Safe" or GRAS under the conditions of intended use ( http://www.cfsan.fda.gov/~dms/opa-noti.html GRAS FDA website). Whether a substance is GRAS is determined either by evidence from published studies or from a general recognition of safety through a significant number of people consuming the food over a long period of time.
We have three different approaches for obtaining GRAS approval (not objected to) in the USA
1. GRAS notification - Executive summary
Dr John Wilkinson's consultancy will review the product in question with regard to its manufacturing process, safety studies, intake and history of use. We will write up an executive summary and provide feed back on whether GRAS is a suitable route for your product.
2. GRAS notification - GAP analysis
If GRAS is a suitable route to approval and marketing authorisation, then the next step is to conduct a complete and thorough GAP analysis of the product to make sure all the necessary studies and analysis have been carried out and to the required standards. Any gaps found in the data will need to be supplied and Dr John Wilkinson's consultancy can undertake the laboratory work and associated studies on behalf of the client if necessary.
3. GRAS notification - Submission of the dossier
Dr John Wilkinson's consultancy will write the GRAS notification and submit (via our USA collaborators) this to the FDA for their review. This also entails the need for an expert panel to review the dossier prior to submission. Dr John Wilkinson's consultancy will arrange a suitable expert panel, either through its own selection process or through collaborative alliances with suitable regulatory consultants in the USA. We can also help with writing and producing a self-affirmed GRAS.
New Dietary Ingredient notifications
New Dietary Ingredients or NDI's (http://www.cfsan.fda.gov/~dms/ds-ingrd.html) are defined by the Dietary Supplement Health and Education Act (1994) as any ingredient that was not marketed in the USA before 15 October 1994. Generally, this means that any manufacturer wishing to market a New Dietary Ingredient must submit a notice to the FDA that demonstrates that the ingredient is reasonably expected to be safe when consumed.
Dr John Wilkinson's consultancy will conduct a review of the clients product as stated in parts 1,2 and 3 above. The dossier for New Dietary Ingredients however differs in that health claims need to be included in the dossier and there is no need for an expert panel to be included in the New Dietary Ingredient notification.
For a press release on a previous successful NDI notification by Dr John Wilkinson's consultancy on behalf of Valensa Inc. see: http://www.nutraingredients-usa.com/news/ng.asp?id=60773-valensa-zanthin-astaxanthin