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Generally recognized as safe

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"GRAS" redirects here. For other uses, see Gras (disambiguation).
Not to be confused with Generally recognized as safe and effective.
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Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use.[1] An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.[2]

The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards.[1][3] Some examples of substances recognized as GRAS include ascorbic acid (vitamin C), citric acid, and salt, which are all commonly used in food preservation and flavoring.[4] The FDA list of GRAS notices is updated approximately each month, as of 2021.[5]

Notification and affirmation

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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.[5] The manufacturer has performed all the aforementioned due diligence, and submitted a GRAS notification to inform the FDA of a determination that the use of a substance is GRAS. Following evaluation, the FDA provides three possible responses: 1. FDA does not question the basis for the notifier's GRAS determination,[5] 2. the notification does not provide a sufficient basis for GRAS determination, or 3. the FDA has, at the notifier's request, ceased to evaluate the GRAS notice.
  • FDA affirmation.[6] Rarely, the FDA can affirm GRAS status through rulemaking on its own initiative.

As of July 2025 (beginning in 1998), 1,234 ingredient or food substances have been filed with the FDA.[5] These petitions, submitted by sponsors or manufacturers, are reviewed for the safety evidence contained in the document. FDA posts status of the review as either without further questions (as a position of "no objection") or the petition is withdrawn by the applicant.[5]

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.[3]

The FDA can also explicitly withdraw the GRAS classification, as it did for trans fat in 2015.[7]

Scientific evidence required

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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.[2]

Scientific procedures for GRAS exemptions require the same quantity and quality of scientific evidence needed to obtain approval of the substance as a food additive, and are ordinarily based upon published studies but may be corroborated by unpublished studies, data, and information.[8][9][2]

Intended use

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The substance must be shown to be "generally recognized" as safe under the conditions of its intended use.[2] To establish GRAS, the proponent must show that there is a consensus of expert opinion that the substance is safe for its intended use.[5] For existing GRAS items, new uses should not substantially exceed historical occurrence levels of the substance in the diet.[2]

Enforcement

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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.[10]

An example of a non-GRAS ingredient requiring enforcement actions in the form of FDA warning letters to 15 companies in 2019 was cannabidiol,[11] which, as of 2024, had not been established with sufficient scientific evidence of safety as a GRAS ingredient.[12]

New Dietary Ingredient process

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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.[13]

History

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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 putting them on the market.[1][3] In 1960, William W. Goodrich, assistant general counsel of the FDA, emphasized that GRAS status under the amendment depended on broad expert consensus, distinguishing it from mere proof of safety, and urged treating doubtful substances as food additives requiring formal approval.[14]

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.[15][16] Between 1974–1976 they also clarified the distinction between GRAS by scientific procedures and by common use in food before 1958.[17][16] In 1997 they replaced the affirmation petition process with the current GRAS notification process because it was slow, resource-intensive, and offered little added public health benefit, while a simpler notification would free resources, encourage industry disclosure, and maintain the same legal safeguards.[16][18]

List of GRAS substances

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The list of GRAS notices (GRAS Notice Inventory) is updated approximately each month by the FDA.[5] The list of GRAS affirmations by FDA appear in Title 21 of the Code of Federal Regulations.

See also

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References

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  1. ^ a b c "How U.S. FDA's GRAS Notification Program Works (original January 2006; updated)". US Food and Drug Administration. 9 February 2018. Archived from the original on 26 September 2019. Retrieved 30 January 2021.
  2. ^ a b c d e "Generally Recognized as Safe (GRAS)". US Food and Drug Administration. 6 September 2019. Retrieved 30 January 2021.
  3. ^ a b c "FDA's Approach to the GRAS Provision: A History of Processes". US Food and Drug Administration. 4 January 2018. Archived from the original on 12 June 2019. Retrieved 30 January 2021.
  4. ^ Program, Human Foods (6 September 2024). "Understanding How the FDA Regulates Food Additives and GRAS Ingredients". FDA.
  5. ^ a b c d e f g "List of GRAS Notices". US Food and Drug Administration. 25 July 2025. Retrieved 10 August 2025.
  6. ^ 21 CFR 170.35
  7. ^ Jalonik, Mary Clare (16 June 2015). "FDA tells food industry to phase out artificial trans fats". Boston Globe. Associated Press. Retrieved 16 July 2019. To phase the fats out, the FDA made a preliminary determination in 2013 that partially hydrogenated oils no longer fall in the agency's "generally recognized as safe" category, which covers thousands of additives that manufacturers can use in foods without FDA review. The agency made that decision final Tuesday, giving food companies until June 2018 to phase them out.
  8. ^ 21 CFR 170.30(b)
  9. ^ "Guidance for Industry: Summary Table of Recommended Toxicological Testing for Additives Used in Food (June 2006, updated periodically)". US Food and Drug Administration. 20 September 2020. Archived from the original on 6 September 2019. Retrieved 30 January 2021.
  10. ^ "Federal Register Proposed Rules – 62 FR 18937 April 17, 1997 – Substances Generally Recognized as Safe [Docket No. 97N–0103]" (PDF). Federal Register, US Department of Health and Human Services. 17 April 1997. Retrieved 30 January 2021.
  11. ^ "FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns". US Food and Drug Administration. 25 November 2019. Archived from the original on 26 November 2019. Retrieved 30 January 2021.
  12. ^ "FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)". US Food and Drug Administration. 16 July 2024. Retrieved 10 August 2025.
  13. ^ Black, Jane (6 August 2025). "Kennedy's Crusade Against Food Safety Rule Threatens Supplement Industry". The New York Times. Retrieved 10 August 2025.
  14. ^ Goodrich, William W. (November 1960). "Safe Food Additives and Additives Generally Recognized as Safe—There is a Difference". The Business Lawyer. 16 (1). American Bar Association: 107–112. JSTOR 40683483. Retrieved 11 August 2025.
  15. ^ 36 FR 20546, 23 October 1971. 37 FR 25705, 2 December 1972.
  16. ^ a b c 62 FR 18938, 17 April 1997. 81 FR 54960, 17 August 2016.
  17. ^ 39 FR 34194, 23 September 1974. 41 FR 53600, 7 December 1976.
  18. ^ Gaynor, Paulette (1 December 2005). "How U.S. FDA's GRAS Notification Program Works". Food Safety Magazine. Food and Drug Administration. Retrieved 10 August 2025.
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