It is vital to recognize that GRAS status is given to the proposed use of an ingredient, not the ingredient itself. There are two separate routes for obtaining GRAS recognition: a GRAS Notification submission to the FDA, where the government issues a letter after an assessment, or a Self GRAS Determination where the FDA is not involved and the stakeholder is responsible for verifying safe use with the review of an expert panel.
In either case, the applicant needs to demonstrate that the substance will not cause harm when the ingredient is ingested under the intended use. To establish this recognition, a complete overhaul of safety needs to be investigated. The Final Ruling on GRAS, which became effective on October 17, 2016, provides specific description of the mandatory information required in the new GRAS Notification procedure. In addition, the FDA has promised that they will respond to GRAS Notifications within 180 days of the original filing. Though, on an as-needed basis, the FDA reserves the right to extend the review timeframe by 90 days, for a total of 270 days.
Our team of experts at dicentra can help your company navigate through this complex procedure by assisting with components or the entire paperwork submission. Our services include:
- Analysis of whether GRAS status is necessary for your ingredient and assisting with the development of a successful regulatory strategy
- Conducting literature searches and data gathering
- Identifying technical and scientific data gaps and recommending solutions
- Coordinating the conduct of toxicological studies when required
- Research for scientific evidence demonstrating that the substance is safe under the conditions of its intended use
- Preparation and submission of GRAS notifications and liaison with FDA and USDA
- Source independent experts and mediate expert panel reports on GRAS conclusions
- Prepare Self GRAS Determination dossiers