Description
For questions regarding this document, contact Julie Schrimpf at the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2373.
Scope & Applicability
Product Classes
4Food 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.
subject to 21 CFR part 111; Foods not subject to preventive controls requirements; Specific product category with modified FSVP requirements.; Included in human food sales calculation; foods not covered under systems recognition arrangements
Information on allergen labeling requirements
Regulatory Context
Attributes
3trans fat is already included in the amount declared for Total Fat
percent Daily Value for trans fat
Trans fat content must be expressed as grams per serving
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)
- 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: FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels (Status: Final)
- Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5) (Status: Final)
- Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts Labels (Status: Final)
- Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics (Status: Final)