GRAS Determinations & Notifications
Exponent’s Center for Chemical Regulation & Food Safety is uniquely qualified to help clients achieve their GRAS (Generally Recognized As Safe) objectives. Our multidisciplinary scientific expertise is augmented by our senior staff members’ years of experience with the food industry and its suppliers, the FDA, and other regulatory agencies. We provide flexible, responsive, cost-effective assistance for all kinds of ingredients. The support we provide ranges from specific expertise to augment the client’s own resources, to comprehensive “ turn-key” GRAS assistance, including strategy, literature searches, data evaluation, expert panels, Notifications, and FDA liaison.
Exponent’s services include:
- Searches of the worldwide scientific and trade literature
- GRAS feasibility evaluations, including strategies for overcoming limitations in available information
- Documentation of history of use
- Expert panels, including identifying qualified experts and coordinating/facilitating their deliberations
- Preparation and submission of GRAS notifications and liaison with FDA and USDA
- Customized assessments of historical, current, and/or anticipated dietary intakes using Exponent/Novigen’s special software, a wealth of information available from U.S. and international sources, and creative, FDA accepted methodologies
- Critical review of available toxicology and medical/epidemiology literature, including statistical analyses.
Among our satisfied clients are the companies that make the world’s best known brands, their suppliers, legal counsel, and trade associations. Our recent GRAS projects include:
- For a manufacturer of food ingredients, we evaluated the potential impact of process changes on safety and GRAS status
- For a law firm, we developed a methodological framework for assessing the potential GRAS status of selected herbal ingredients in foods
- For the producer of an ingredient having functional advantages in both FDA- and USDA regulated products, we developed a GRAS Notification based on "scientific procedures" and coordinated FDA and USDA review
- For a processed food company, we critically reviewed the scientific literature, performed a "gap analysis" of data needs, and developed a strategy for GRAS determination of an ingredient
- To assist an investor group with their business plan and SEC filing, we evaluated available data and literature, obtained reviews by outside experts, and assessed the feasibility and timeline for the GRAS status of a microorganism intended as a probiotic.