GRAS (Generally Recognized as Safe) is a regulatory designation set by the U.S. FDA. GRAS applies to any substance intentionally added to a food, such as a food additive. As the food industry continues to grow and new ingredients are being investigated, achieving GRAS status has become more valuable.
Our regulatory team, GRAS Associates, has unparalleled expertise in GRAS filings, having completed ~15% of all GRAS notices received by the FDA since 2008. Our 90% success rate exceeds the industry average of 72%, providing you with added confidence.
To secure GRAS status for an ingredient, the Sponsor must demonstrate that the substance is not likely to cause harm when used as intended. This requires a complete safety review and submission of a GRAS dossier to the FDA.
Through our successful delivery of GRAS evaluations and ingredient safety assessments, our clients gain access to greater market opportunities through innovative and expanded product offerings. Our in-depth capabilities in food safety, including New Dietary Ingredient Notifications (NDIN), guarantee efficient and cost-effective solutions to enter new markets, introduce new products, and comply with changes in the regulatory landscape.
Learn how we can help you achieve GRAS status for your ingredient.
GRAS vs. NDIN: Which is the Right Regulatory Strategy for My Ingredient?
Know the differences, then decide which is best for your product.
Implications of FDA's GRAS and NDIN Policy Changes for Supplements and Medical Foods
We explain how to understand and adapt to these policy changes.