Generally recognized as safe

GRAS substances can be self-affirmed upon determination by qualified non-governmental experts, with or without FDA notification, or the FDA itself can affirm: • Self-affirmation without FDA notification. The manufacturer of this chemical or substance had performed all necessary research, including the formation of an expert panel to review safety concerns, and is prepared to use these findings to defend its product's GRAS status. FDA is not notified. • Self-affirmation with FDA notification. Rarely, the FDA can affirm GRAS status through rulemaking on its own initiative. For substances used in food prior to January 1, 1958, a grandfather clause allows experience based on common use in food to be used in asserting an ingredient is safe under the conditions of their intended use. The FDA can also explicitly withdraw the GRAS classification, as it did for trans fat in 2015. ==Scientific evidence required==

For new proposals, the proponent of the GRAS exemption usually a food manufacturer or ingredient supplier wishing to highlight a food ingredient in its manufactured product has the burden of providing rigorous scientific evidence that use of the substance in an edible consumer product is safe. FDA has not issued guidance to companies on how to document their GRAS determinations. ==Intended use==

The substance must be shown to be "generally recognized" as safe under the conditions of its intended use. To establish GRAS, the proponent must show that there is a consensus of expert opinion that the substance is safe for its intended use. For existing GRAS items, new uses should not substantially exceed historical occurrence levels of the substance in the diet. ==Enforcement==

When use of a substance does not qualify for the GRAS exemption, it is subject to the premarket approval mandated by the Federal Food, Drug, and Cosmetic Act. In such circumstances, the FDA can take enforcement action to stop distribution of the food substance and foods containing it on the grounds that such foods are not deemed GRAS or contain an unlawfully added ingredient. A substance that fails to qualify as GRAS is treated as an unsafe food additive, rendering the food adulterated under (a)(2)(C)(i). Enforcement is discretionary. The FDA may proceed through judicial actions (e.g., seizure or injunction under ) or impose civil monetary penalties (under (f)(2)). Civil monetary penalty proceedings are conducted under , with an initial decision by an administrative law judge and administrative appellate review by the Departmental Appeals Board. An example of a non-GRAS ingredient requiring enforcement actions in the form of FDA warning letters to 15 companies in 2019 was cannabidiol, which, as of 2024, had not been established with sufficient scientific evidence of safety as a GRAS ingredient. ==New Dietary Ingredient process==

The separate New Dietary Ingredient (NDI) notification process is FDA's premarket system for certain ingredients in dietary supplements defined in the Dietary Supplement Health and Education Act of 1994 (DSHEA). Supplement makers have been accused of "routinely and systematically" bypassing the DSHEA NDI process by using GRAS exemptions: first adding new compounds to a food and self-certifying, with or without FDA notification, then adding them to supplements. ==History==

On 6 September 1958, the Food Additives Amendment of 1958 was signed into law, with a list of 700 food substances that were exempt from the then-new requirement that manufacturers test food additives before the manufactured foods were marketed. In the 1970s and 1980s, the FDA engaged in a systematic reconsideration of the safety of GRAS substances, giving a timeline of GRAS policies from 1958 to 2005. In 1971, FDA issued criteria for determining GRAS status on its own initiative, and in 1972, the GRAS affirmation petition process was created to allow individuals to initiate reviews. In 1997, the FDA replaced the "GRAS affirmation process with a [voluntary] notification procedure" for which any person or company could notify the FDA that a substance had convincing scientific evidence for GRAS status under the conditions of its intended use to unburden agency resources, encourage industry disclosure, and maintain legal safeguards. Starting in 2000, Redbook 2000 provides core FDA guidelines for toxicity testing of direct food additives covering GRAS under 21 CFR § 170.3, including tiered studies and ADME evaluations. ==Concerns about ingredient safety==

In 2010, the United States Government Accountability Office (GAO) published a report about potential deficiencies in the GRAS review process, giving four main areas of concern: • the GRAS oversight process does not confirm the safety of all new ingredient assessments. This potential deficiency occurs because the FDA assesses GRAS petitions only if the manufacturer voluntarily notifies the FDA. • the FDA has not provided guidance to companies for sufficiently documenting scientific evidence of safety in GRAS petitions. • there is no final FDA regulation for criteria in the voluntary notification program, challenging credibility for GRAS status, and there exists insufficient monitoring in the public market for the continued safety of GRAS substances. • companies considering use of engineered nanomaterials in food can use the voluntary GRAS notification process, assuming full safety without the FDA having a complete assessment. In contrast to this absence of review, nanomaterials intended for use in foods must be fully reviewed for safety in Canada and the European Union before marketing. Despite consumer group objections that this change would soften premarket safety scrutiny on new food ingredients, including a 2017 lawsuit by Center for Food Safety against the FDA, in 2021 a federal district court found that the FDA did not unlawfully delegate its authority over food safety, and that the rule was compliant with the Federal Food, Drug, and Cosmetic Act. The review provided recommendations for improving the GRAS process, including mandatory premarket assessments with application fees, more transparency in postmarket FDA review of GRAS substances and other additives used in food manufacturing, and additional resources to be allocated by Congress. Conflict of interest when a company pays or (indirectly) funds another company or individual to prove food additives as GRAS. In May 2025, the FDA announced it was planning a systematic postmarket review of GRAS substances. The announcement indicated increased scrutiny and burden of compliance for food manufacturers to justify GRAS, and a possible reevaluation of existing GRAS notifications. ==List of GRAS substances==

The list of GRAS notices (GRAS Notice Inventory) is updated approximately each month by the FDA. FDA posts status of the review as either without further questions (as a position of "no objection"), pending review, or the petition is withdrawn by the applicant. == See also ==