Description
The Food and Drug Administration (FDA) has prepared this guide in accordance with section 212 of the Small Business Regulatory Fairness Act. This guidance document represents the agency's current thinking on the statement of identity, nutrition labeling, and ingredient labeling of dietary supplements. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Scope & Applicability
Product Classes
2Category of products covered in the table of contents; Covered by allergen labeling requirements; Guidance on declaring major food allergens for dietary supplements.
Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
Stakeholders
2Target audience for the compliance guide
Entity responsible for submitting NDINs
Regulatory Context
Attributes
2Configuration of the statement of identity and strength
Percentage of nutrient contribution to a daily diet.
Related CFR Sections (3)
- 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 →
- 21CFR101.36§ 101.36 Nutrition labeling of dietary supplements.
(a) The label of a dietary supplement that is offered for sale shall bear nutrition labeling in accordance with this regulation unless an exemption is provided for the product in paragraph (h) of this section.Read full regulation →
- 21CFR101.9§ 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.Read full regulation →
Related Warning Letters (10)
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Valentine Enterprises, Inc.
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2024-11-05
CGMP/Dietary Supplement/Adulterated
Top Health Manufacturing, LLC
- 2024-07-23
New Drugs/Dietary Supplements/Food Labeling/Misbranded
Formulation Technology, Inc.
- 2023-09-05
Unapproved New Drugs/Misbranded
Osmosis, LLC
- 2023-08-29
CGMP/Dietary Supplement/Adulterated/Misbranded
Cosmax NBT USA
- 2023-02-07
CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Quality Supplement Manufacturing, Inc.
- 2023-01-31
CGMP/Dietary Supplement/Misbranded
Adept Life Science, LLC
- 2023-01-24
Dietary Supplement/Misbranded
Evimeria El Aztecano, Inc.
- 2022-08-30
Food Labeling/Misbranded
National Food Industries LLC
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)