Description
This guidance addresses how conventional food and dietary supplement manufacturers should declare small amounts of nutrients and dietary ingredients on nutrition labels.
Scope & Applicability
Product Classes
2Food marketed for general consumption, distinct from dietary supplements.; Comparison point for intake levels
Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
Related CFR Sections (2)
- 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 →
- 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 →
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)
- Guidance for Industry: Guide for Developing and Using Data Bases for Nutrition Labeling (Status: Final)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels (Status: Final)
- Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals (Status: Final)
- Small Entity Compliance Guide: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (Status: Final)
- Small Entity Compliance Guide: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Status: Final)
- Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part II (Status: Final)
- Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5) (Status: Final)