Food & Beverage
Many regulatory challenges exist before bringing your new food ingredient to market. These include establishing safety, labeling, and substantiation of claims before establishing position in the marketplace.
Safety is the first step in getting your new food ingredient to market. Before a new ingredient can be added to food in the U.S., it must be either prior sanctioned, an approved food additive or Generally Recognized As Safe (GRAS). Most companies choose the GRAS route to expedite time to market. RNI Consulting offers the following services to help bring your new ingredient to the US market.
- 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 GRAS determination.
- Study Placement and Manuscript Services If additional safety data is required to support a GRAS determination or substantiate a claim, we will make recommendations for study placement, review of draft reports and manuscript preparation for submission to peer reviewed journals.
- Generally Recognized As Safe (GRAS) 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.