Description
This guidance document is intended to provide our recommendations on best practices for convening a “GRAS panel.” By “GRAS,” we mean “generally recognized as safe.” See section II.A for a discussion of the GRAS provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act). By “GRAS panel,” we mean a panel of qualified experts who independently evaluate whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in human food or animal food as part of an evaluation of whether adding that substance to food is lawful under the GRAS provision of the FD&C Act.
Scope & Applicability
Product Classes
5Substances used in human food evaluated for safety.; Substances intended for use in food for humans.
Specialized expertise applicable to the scientific considerations associated with the intended conditions of use of a food substance.
subject to 21 CFR parts 106 and 107
Substances used in animal food evaluated for safety.; Substances intended for use in food for animals.
Section 201(s) of the FD&C Act defines a 'food additive'
Stakeholders
8party who assembles a GRAS panel; A proponent or third party responsible for convening a GRAS panel.; These decisions are the GRAS panel organizer's responsibility.; The person or entity that provides data to the GRAS panel and documents its deliberations.
Individuals serving on FDA advisory committees
An individual qualified by scientific training and experience to evaluate the safety of substances in food.
A panel of qualified experts who independently evaluate whether scientific data establish safety.; experts who would be both qualified and available to serve on a GRAS panel; A GRAS panel report could not provide evidence that the available data and information are generally accepted if there is a severe conflict among experts.; A panel of experts convened to evaluate whether the use of a substance is safe and generally recognized as safe.
A person responsible for a conclusion that a substance may be used in food on the basis of the GRAS provision.; The party using GRAS panel information to reach a decision; party who takes responsibility for a conclusion of GRAS status; The GRAS panel report would more appropriately be a resource for the proponent to use in identifying data gaps.; The entity responsible for drawing a conclusion on whether a substance satisfies GRAS criteria.
persons who assemble a GRAS panel and provide the framework for its deliberations
Advisory committee members subject to conflict of interest requirements; advisory committee members during their service; Enabling participation of a Special Government Employee in an FDA advisory committee.
person responsible for a GRAS notice submitted to FDA; The person who submitted the GRAS notice.
Regulatory Context
Attributes
5The standard for substances added to food under the FD&C Act.
Compensation provided to members of a GRAS panel.
conflict of interest restriction for qualified individuals
Safe level of intake is in a narrow range
A key aspect of the GRAS criteria supported by scientific evidence
Identified Hazards
Hazards
2Ongoing scientific discussion or controversy about safety concerns
mitigate potential unwanted bias in learning or performance estimation
Related CFR Sections (7)
- 21CFR170.38§ 170.38 Determination of food additive status.
(a) The Commissioner may, in accordance with § 170.35(b)(4) , publish a notice in the Federal Register determining that a substance is not GRAS under the conditions of its intended use and is a food additive subject to section 409 of the Federal Food, Drug, and Cosmetic Act.Read full regulation →
- 21CFR170.225§ 170.225 Part 1 of a GRAS notice: Signed statements and certification.
(a) Part 1 of your GRAS notice must be dated and signed by a responsible official of your organization, or by your attorney or agent.Read full regulation →
- 21CFR570.250§ 570.250 Part 6 of a GRAS notice: Narrative.
In Part 6 of your GRAS notice, you must include a narrative that provides the basis for your conclusion of GRAS status, in which:Read full regulation →
- 21CFR170.250§ 170.250 Part 6 of a GRAS notice: Narrative.
In Part 6 of your GRAS notice, you must include a narrative that provides the basis for your conclusion of GRAS status, in which:Read full regulation →
- 21CFR570.30§ 570.30 Eligibility for classification as generally recognized as safe (GRAS).
(a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be eitherRead full regulation →
- 21CFR170.30§ 170.30 Eligibility for classification as generally recognized as safe (GRAS).
(a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be eitherRead full regulation →
- 21CFR14.80§ 14.80 Qualifications for members of standing policy and technical advisory committees.
(a) Members of a policy advisory committee—Read full regulation →
Related Warning Letters (10)
- 2025-09-30
Adulterated Human Foods/Misbranded
STNR Creations, LLC
- 2025-09-16
Adulterated Human Foods/Misbranded
Blue Forest Farms, LLC
- 2025-08-12
Adulterated Human Foods/Misbranded
TKO Distribution, LLC
- 2025-07-15
Unapproved New Drug/Human Food/Adulterated
Hydroxie, LLC
- 2025-07-15
Unapproved New Drug/Misbranded
Royal Diamond Imports, Inc.
- 2025-07-15
CGMP/Dietary Supplement/Adulterated/Misbranded
Thang Botanicals, Inc. d/b/a 7ΩHMZ, 7-OHMZ, or 7OHMZ
- 2025-06-03
Adulterated Human Foods/Misbranded
Latro Inc.
- 2025-04-29
Unapproved New Animal Drug Products
Holista LLC dba HolistaPet
- 2025-04-29
Unapproved New Animal Drug Products
Bailey’s Wellness, LLC dba Bailey’s CBD
- 2024-07-23
Adulterated Human Foods/Unapproved New Drugs
White Label Leaf, LLC/Flying Monkey US, LLC
See Also (8)
- Guidance for Industry: Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices for Enzyme Preparations (Status: Final)
- CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (Status: Final)
- CVM GFI #220 Use of Nanomaterials in Food for Animals (Status: Final)
- CPG Sec. 690.150 Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases (Status: Final)
- Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food (Status: Final)
- CVM GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds (Status: Final)
- Draft Guidance for Industry: Voluntary Sodium Reduction Goals (Edition 2) (Status: Draft)