For companies developing new food ingredients or dietary supplement components, achieving GRAS status is a critical milestone. While the FDA offers a formal GRAS Notification process, many businesses choose an alternative route known as FDA Self-Affirmed GRAS. This pathway allows manufacturers to independently determine an ingredient’s safety based on scientific evidence and expert consensus, enabling faster time-to-market without formal FDA review.
What Is FDA Self-Affirmed GRAS?
FDA Self-Affirmed GRAS refers to a regulatory pathway where a company evaluates the safety of an ingredient using qualified experts and scientific data to conclude it is Generally Recognized As Safe (GRAS) under its intended conditions of use. Unlike the GRAS Notification process, this approach does not require submitting documentation to the FDA—though the same level of scientific rigor and documentation is expected.
Once an ingredient is self-affirmed GRAS, it can legally be marketed and used in food products in the U.S., provided all safety documentation is complete and available upon request.
Key Advantages of FDA Self-Affirmed GRAS
Faster market access – No waiting for FDA review or response
Confidentiality – Keep proprietary data and formulations private
Regulatory compliance – Meets U.S. legal requirements for food safety
Scientific credibility – Based on peer-reviewed data and expert evaluation
The Self-Affirmed GRAS Process
The self-affirmation process requires a systematic and well-documented evaluation of the ingredient’s safety. At GRAS Experts, we guide clients through each essential step:
Scientific Literature Review – An in-depth analysis of published safety data relevant to the ingredient.
Toxicological and Safety Assessments – Comprehensive reviews of human and animal studies to determine safe intake levels.
Expert Panel Formation – A team of independent, qualified scientists evaluates the data to reach a GRAS conclusion.
GRAS Dossier Preparation – A complete, structured document outlining the scientific evidence and rationale for safety.
Legal and Regulatory Compliance – Ensuring all documentation is defensible in case of FDA inquiry or challenge.
Why Choose GRAS Experts?
With decades of combined experience in toxicology, regulatory science, and FDA compliance, GRAS Experts is uniquely positioned to help you navigate the FDA Self-Affirmed GRAS process. Our team delivers custom strategies, rigorous scientific assessments, and high-quality documentation that meets both industry and regulatory expectations.
Whether you're launching a novel ingredient or seeking to expand an existing product’s applications, we offer the expertise you need to ensure your self-affirmation process is credible, compliant, and market-ready.
