Description
For updated examples of nutrition labels seeExamples of Revised Nutrition Facts Panel Listing Trans FatExternal Link Disclaimer.
Scope & Applicability
Product Classes
1Top 20 most frequently consumed raw foods
Stakeholders
5Entity responsible for submitting NDINs
Office within CFSAN that prepared the guidance.
Office within CFSAN that prepared the guidance.
Responsible for choosing mean or predicted value for labels
Entity responsible for designing the sampling plan and collecting data.; Entity responsible for developing the nutrition database and calculating label values.; Entity creating the nutrient data base
Regulatory Context
Attributes
10Nutrients added in fortified or fabricated foods (vitamins, minerals, protein, fiber, potassium)
Statistical basis for FDA recalculation of label values
Updated values used for calculating percent Daily Values; Updated values used to calculate Percent DV
Updated values used for calculating percent Daily Values; RDIs used in the declaration of the percent DV of nutrients; nutrition information for two different RDI groups
percentage used to define nutrient limits (e.g., 10% DV); Used to quantify the amount of Added Sugars per serving (20% Daily Value).
Variability limit of not more than 15% for qualification
Basis for establishing serving sizes; Basis for determining serving sizes in labeling.
Statistical range used in calculating label values from laboratory data.
Naturally occurring vitamins, minerals, protein, carbohydrate, fiber, fat, or potassium; Potassium and vitamin C are categorized as class II nutrients for labeling purposes.
Nutrients including calories, sugars, total fat, saturated fat, cholesterol, and sodium
Related CFR Sections (4)
- 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 →
- 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 →
- 21CFR101.45§ 101.45 Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish.
(a) Nutrition labeling for raw fruits, vegetables, and fish listed in § 101.44 should be presented to the public in the following manner:Read full regulation →
- 21CFR101.12§ 101.12 Reference amounts customarily consumed per eating occasion.
(a) The general principles and factors that the Food and Drug Administration (FDA) considered in arriving at the reference amounts customarily consumed per eating occasion (reference amounts) which are set forth in paragraph (b) of this section, are that: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)
- Guidance for Industry: Food Labeling Guide (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: 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)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)