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, that is not a food additive, colour additive, or prior sanctioned ingredient. 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 in the format and content expected by 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.
Did you know? GRAS is applicable to cannabis-derived products such as cannabidiol (CBD).
Contact us to learn how we can help you achieve GRAS status for your ingredient.
Is Generally Recognized as Safe a Viable Pathway for CBD Market Access?
Here are the top FAQs we receive about CBD marketing, sales, and compliance—including GRAS—for the U.S. market.
GRAS vs. NDIN: Which is the Right Regulatory Strategy for My Ingredient?
Know the differences, then decide which is best for your product.