Bio: Ms Shannon Cousineau is a senior scientist at NSF with the responsibility of preparing GRAS and NDI documents.

Abstract: Two US regulatory programs will be discussed. "GRAS" is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive that is subject to premarket review and approval by the 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, or unless the use of the substance is otherwise excepted from the definition of a food additive. FDA strongly encourages following the GRAS notification program following the available procedures for FDA oversight of GRAS conclusions. The term "new dietary ingredient" means a dietary ingredient not marketed in the United States as a dietary supplement before October 15, 1994. (See section 413(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 350b(d)). The regulatory process for both GRAS and NDI will be discussed.