Generally recognized as safe (GRAS) (1) is the U.S. Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe.
What Is GRAS?
Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (2), 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, or unless the use of the substance is otherwise excepted from the definition of a food additive.
Furthermore, under this Act, and FDA's implementing regulations in Title 21 Code of Federal Regulations (CFR) 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive. General recognition of safety through scientific procedures is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers.(1)
History of GRAS
On January 1, 1958, the FDA established the Food Additives Amendment of 1958. Under the Amendment to the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is a food additive and is subject to pre-market approval by FDA unless the use of the substance is generally recognized as safe (GRAS) (or otherwise excepted from the definition of food additive – e.g., color additive).
On August 31, 1960, assistant general council of the FDA, William W. Goodrich addressed the annual meeting of the FFDCA, which was the forthcoming March 6, 1961, effective date of the enforcement provisions of the "Food Additives Amendment of 1958", referred to as GRAS. (3)
By 1961, the FDA had amended its regulations to include a list of 700 food substances that were exempt from the then-new requirement before putting them on the market. (3) During the 1960s, many manufacturers requested FDA’s opinion on whether their conclusions of GRAS status were justified and received opinion letters. In 1969, FDA removed one substance, cyclamate salts from its GRAS list as a result of safety questions, and then-President Nixon directed the FDA to reexamine the safety of GRAS substances. In the 1970s, FDA announced that it was conducting a comprehensive review of presumed GRAS substances and established rulemaking procedures to affirm the GRAS status of substances that were either on the GRAS list or the subject of a petition (GRAS affirmation). To eliminate the resource-intensive rulemaking procedures, in 1997, FDA proposed to replace the GRAS affirmation petition process with a notification procedure (GRAS notification). Several iterations of the GRAS rule have been created over the years with the most recent occurring in 2010 as part of the greater updated CFR guidelines released by the FDA. (2)
FDA GRAS Rules
On April 17, 1997, the FDA published the proposed GRAS rule in the Federal Register. (4) Ingredients to be added to foods in the US require GRAS status or approval from FDA as a food additive. It is important to understand that it is the intended use of an ingredient that is GRAS, not the ingredient itself. Subjects that ...
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