Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process

Description

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Scope & Applicability

Regulatory Context

• 21CFR71.1§ 71.1 Petitions.

  (a) Any interested person may propose the listing of a color additive for use in or on any food, drug, or cosmetic or for coloring the human body. Such proposal shall be made in a petition in the form prescribed in paragraph (c) of this section. The petition shall be submitted in triplicate (quadrupRead full regulation →

• 21CFR171.1§ 171.1 Petitions.

  (a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) shall be submitted in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product). If any part of the material submRead 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 →

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• 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.

  2025-08-26

• 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

  2024-09-11

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  Samm Solutions, Inc., d.b.a. BTS Research

  2023-10-31

• Bioresearch Monitoring Program

  Valley Biosystems

  2022-08-09

• Good Laboratory Practice (GLP)

  Toxikon Corporation/Labcorp Bedford LLC

  2022-02-22

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  University of Kentucky

  2020-05-05

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  Steiner Biotechnology, LLC

  2020-04-07

• CPG Sec 500.425 Use of Color Additives in Paper and Paperboard Intended for Use with Food (Status: Final)
• Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices (Status: Final)
• Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Status: Final)
• Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (Status: Final)
• Small Entity Compliance Guide: Declaration by Name on the Label of All Foods and Cosmetic Products that Contain Cochineal Extract and Carmine (Status: Final)
• Color Additive Petitions - Medical Devices (Status: Final)
• Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency (Status: Final)
• Draft Guidance for Industry: Cosmetic Good Manufacturing Practices (Status: Draft)