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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]

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.[3] 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][4]

Affirmation and notification

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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.

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.[4]

The FDA can also explicitly withdraw the GRAS classification, as it did for trans fat in 2015.[7][8]

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.[2][9][10] FDA has not issued guidance to companies on how to document their GRAS determinations.[11]

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.[12]

An example of a non-GRAS ingredient requiring enforcement actions in the form of FDA warning letters to 15 companies in 2019 was cannabidiol,[13] which, as of 2024, had not been established with sufficient scientific evidence of safety as a GRAS ingredient.[14]

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.[15]

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 the manufactured foods were marketed.[1][4] 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.[16]

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.[17] 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.[18][19] Between 1974–1976, the FDA clarified the distinction between GRAS by scientific procedures and by common use in food before 1958.[19][20]

In 1997, the FDA replaced the resource-intensive affirmation GRAS petition with an interim notification procedure until a simpler GRAS process could be implemented to unburden agency resources, encourage industry disclosure, and maintain legal safeguards.[19][21] In 2016, the FDA implemented an amendment "to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use".[22]

Despite consumer group objections that this change would soften premarket safety scrutiny on new food ingredients, including a 2021 lawsuit against the FDA, 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 Cosmetics Act.[23]

Concerns about ingredient safety

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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:[11]

  • 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.

A 2024 review of the FDA GRAS program identified several deficiencies, including the large volume of food additives needing better scrutiny, the strained resources for constant FDA surveillance, delays in enforcement action, and limited postmarket overview to ensure ingredient safety.[23] 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.[23]

In contrast to the need for increased resources to support the FDA, including improvements to the GRAS system, thousands of FDA employees were fired by the Trump Administration in April, 2025.[24]

In May 2025, the FDA announced it was planning a systematic postmarket review of GRAS substances.[25] The announcement indicated increased scrutiny and burden of compliance for food manufacturers to justify GRAS, and a possible reevaluation of existing GRAS notifications.[25] A congressional rule change for the GRAS review process was also submitted in early 2025.[26]

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. As of September 2025 (beginning in 1998), approximately 1,240 ingredient or food substances have been filed with the FDA, with dozens of applications pending.[5] 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.[5]

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. ^ Program, Human Foods (6 September 2024). "Understanding How the FDA Regulates Food Additives and GRAS Ingredients". FDA.
  4. ^ 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.
  5. ^ a b c d e f "Inventory of GRAS Notices". US Food and Drug Administration. 30 September 2025. Retrieved 6 November 2025.
  6. ^ 21 CFR 170.35, 21 CFR 170.38.
  7. ^ 21 CFR 170.38. 21 U.S.C. § 348(i).
  8. ^ 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.
  9. ^ 21 CFR 170.30(b)
  10. ^ "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.
  11. ^ a b Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) (Report). United States Government Accountability Office. 5 March 2010. Retrieved 17 August 2025.
  12. ^ "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.
  13. ^ "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.
  14. ^ "FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)". US Food and Drug Administration. 16 July 2024. Retrieved 10 August 2025.
  15. ^ Black, Jane (6 August 2025). "Kennedy's Crusade Against Food Safety Rule Threatens Supplement Industry". The New York Times. Retrieved 10 August 2025.
  16. ^ 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.
  17. ^ Gaynor, Paulette M.; Bonnette, Richard; Garcia, Jr., Edmundo; Kahl, Linda S.; Valerio, Jr., Luis G. (4 January 2018). "FDA's Approach to the GRAS Provision: A History of Processes". Food and Drug Administration. Retrieved 17 August 2025.
  18. ^ 36 FR 20546, 23 October 1971. 37 FR 25705, 2 December 1972.
  19. ^ a b c 62 FR 18938, 17 April 1997. 81 FR 54960, 17 August 2016.
  20. ^ 39 FR 34194, 23 September 197441 FR 53600, 7 December 1976
  21. ^ 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.
  22. ^ "Substances Generally Recognized as Safe: A Rule by the Food and Drug Administration on 08/17/2016". Federal Register: Department of Health and Human Services, Food and Drug Administration: 21 CFR Parts 20, 25, 170, 184, 186, and 570. 8 September 2016. Retrieved 12 November 2025.
  23. ^ a b c Pomeranz JL, Broad Leib EM, Mozaffarian D (October 2024). "Regulation of Added Substances in the Food Supply by the Food and Drug Administration Human Foods Program". American Journal of Public Health. 114 (10): 1061–1070. doi:10.2105/AJPH.2024.307755. PMC 11375365. PMID 39116397.
  24. ^ Valencia N, Goodman B, Tirrell M, Luhby T, Lyngaas S (2 April 2025). "'It's a bloodbath': Massive wave of job cuts underway at US health agencies". CNN. Retrieved 12 November 2025.
  25. ^ a b "FDA Advances Robust, Transparent Post-Market Chemical Review Program to Keep Food Supply Safe and Healthy". Food and Drug Administration. 15 May 2025. Retrieved 17 August 2025.
  26. ^ "Substances Generally Recognized as Safe". US General Services Administration, Office of Management and Budget. Spring 2025. Retrieved 12 November 2025.
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