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
Product Classes
1articles used for food or drink for man or other animals
Stakeholders
2Entities involved in the supply chain of APIs.
Responsible for declaring acceptable market names on labels.
Related CFR Sections (2)
- 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 →
- 21CFR101.13§ 101.13 Nutrient content claims—general principles.
(a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods and dietary supplements.Read full regulation →
Related Warning Letters (10)
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-06-24
Food Labeling/Misbranded
Revolution Foods, PBC
- 2025-06-03
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
One Roof LLC
- 2024-12-03
CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Mena Food Group, LLC
- 2024-10-15
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Alfred Louie, Inc.
- 2024-10-01
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
NRS Enterprises, Inc. d/b/a Sunflour Bakery
- 2024-06-11
Acidified Foods/Prepared Packed or Held Under Insanitary Conditions
Midwest Foods, LLC
- 2024-05-14
Food Labeling/Misbranded
California Bread Co.
- 2024-05-07
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Sheng Kee of California, Inc dba Sheng Kee Bakery
- 2024-04-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Misbranded
Korean Food, Inc.
See Also (8)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 442.100 New Drugs - Export (Status: Final)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (Status: Final)
- CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (Status: Final)
- CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products (Status: Final)
- CPG Sec. 400.500 Identical or Similar Product Names (Status: Final)