Description
FDA regulates foods and substances added to food under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Many substances added to foods are food additives. Section 201(s) of the FD&C Act (21 U.S.C. § 321(s)) defines a “food additive” as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component of or otherwise affecting the characteristics of any food.” Section 201(s) excludes from this definition any substance that is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or that qualifies for any of the other exemptions from the food additive definition (e.g., new animal drug, color additive, etc.).
Scope & Applicability
Product Classes
3Substances added to animal food requiring approval
Target Animal Safety for Veterinary Pharmaceutical Products
Approved substances for direct addition to food
Stakeholders
3Party submitting a citizen petition; party evaluating whether a food allergen is of public health importance; Party recommended to conduct systematic reviews and evidence scoring.
CVM division for pre-petition consultations
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
3Determined by the sponsor for the investigational product.; investigational product(s) are stable over the period of use and only used within the current shelf life
Acceptable daily intake established for antimicrobial residues; General approach to establish a microbiological Acceptable Daily Intake; An ADI established on the basis of microbiological data
should be based on appropriate supportive stability data
Identified Hazards
Hazards
3Impurities that must be limited in specifications
Extraordinary circumstance for environmental review
Public health threat resulting from loss of effectiveness of antimicrobial therapies; Efforts to mitigate the development of antimicrobial resistance.; Public health concern that labeling changes aim to mitigate.; development and spread of antimicrobial resistance encouraged by certain practices
Related CFR Sections (9)
- 21CFR571.1§ 571.1 Petitions.
(a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the act shall be submitted in triplicate. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state petitiRead full regulation →
- 21CFR25.40§ 25.40 Environmental assessments.
(a) As defined by CEQ in 40 CFR 1508.9 , an EA is a concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an EIS or a FONSI. The EA shall include brief discussions of the need for the proposal, of alternatives as required by secRead full regulation →
- 21CFR25.21§ 25.21 Extraordinary circumstances.
As required under 40 CFR 1508.4 , FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of signRead full regulation →
- 21CFR25.15§ 25.15 General procedures.
(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraRead full regulation →
- 21CFR25.32§ 25.32 Foods, food additives, and color additives.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR570.17§ 570.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.
A food additive or food containing a food additive intended for investigational use by qualified experts shall be exempt from the requirements of section 409 of the act under the following conditions: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 →
- 21CFR570.35§ 570.35 Affirmation of generally recognized as safe (GRAS) status.
(a) The Commissioner, on his own initiative, may affirm that a substance that directly or indirectly becomes a component of food is GRAS under the conditions of its intended use.Read full regulation →
- 21CFR170.3§ 170.3 Definitions.
For the purposes of this subchapter, the following definitions apply:Read full regulation →
Related Warning Letters (10)
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 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
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Sanitation & Environmental Technology Institute dba SDWH
- 2023-10-31
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Samm Solutions, Inc., d.b.a. BTS Research
- 2022-11-21
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Infusionz, LLC
- 2022-08-09
Bioresearch Monitoring Program
Valley Biosystems
- 2022-05-26
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Plantacea, LLC dba Kahm
See Also (8)
- CVM GFI #80 Evaluation the Utility of Anti-Salmonella Chemical Food Additives (Status: Final)
- Guidance for Industry: Appendix B for Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Guidance for Industry: Appendix A of Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Guidance for Industry: Appendix C of Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- CVM GFI #89 (VICH GL6) EIAs for Veterinary Medicinal Products - Phase I (Status: Final)
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (Status: Draft)
- CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (Status: Final)