You have options in achieving regulatory compliance for your new dietary ingredient under the Dietary Supplement Health and Education Act. The most obvious option is the New Dietary Ingredient Notification (NDIN) process. However, if the ingredient has been recognized as a food substance and is already present in the food supply an NDIN is not required. The Generally Recognized As Safe (GRAS) process is therefore an option for your new dietary ingredient and in some cases the better choice. Below are services offered by RNI Consulting to help bring your new ingredient to market efficiently.
- Regulatory Review and Gap Analysis The process starts with a gap analysis between what is known about your product identity, its regulatory status, history of use and safety, and what is needed to support a NDIN or GRAS determination.
- New Dietary Ingredient Notifications (NDIN) When your best option is to submit a NDIN, we assemble an expert team and prepare your NDIN for submission to FDA.
- Generally Recognized As Safe (GRAS) Depending on the identity and history of use of your ingredient, choosing the GRAS route for your ingredient may be the best path forward. We assemble the expert team and manage the entire GRAS process including preparation of the optional notification.
- Structure Function Claims Product positioning drives sales. We research existing data to support claims for your ingredient and arrange clinical study placement and manuscript preparation as needed.
- Label Review We review your product label and make recommendations for changes to comply with FDA regulation.