Technical / White Paper
GRAS: Gain US Market Access
What is GRAS? Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use. But how is safety determined? Are there exceptions to this rule? Are there different types of GRAS? Get the answers in this whitepaper by renowned Contract Research Organization (CRO) and regulatory consulting firm, dicentra.