Food Labeling Guide

September 1994; Revised April 2008; Revised October 2009

Guidance for Industry: A Food Labeling Guide

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The document below is available in several foreign language(s). FDA offers these translations as a service to a broad international audience. We hope that you find these translations useful. While the agency has attempted to obtain translations that are as faithful as possible to the English version, we recognize that the translated versions may not be as precise, clear, or complete as the English version. The official version of this document is the English version.

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Office of Nutrition, Labeling, and Dietary Supplements
HFS-800
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) (301) 436-2375 (Updated phone: 240-402-2375)
www.fda.gov/FoodLabelingGuide

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutrition, Labeling and Dietary Supplements
October 2009

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Contains Nonbinding Recommendations  

Guidance for Industry⁽¹⁾
A Food Labeling Guide

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. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.

Table of Contents

1. Introduction
2. Background
3. General Food Labeling Requirements
4. Name of Food
   • Juices
5. Net Quantity of Contents Statements
6. Ingredient Lists
   • Colors
   • Food Allergen Labeling
7. Nutrition Labeling
   • General
   • Nutrient Declaration
   • Products with Separately Packaged Ingredients/Assortments of Foods
   • Label Formats/Graphics
     • General
     • Specific Label Formats
     • Trans Fat Labeling
     • Miscellaneous
     • Serving Size
     • Exemptions/Special Labeling Provisions
8. Claims
   • Nutrient Content Claims
   • Health Claims
   • Qualified Health Claims
   • Structure/Function Claims
9. Appendix A: Definitions of Nutrient Claims
10. Appendix B: Additional Requirements for Nutrient Content Claims
11. Appendix C: Health Claims
12. Appendix D: Qualified Health Claims
13. Appendix E: Additional FDA Resources
14. Appendix F: Calculate the Percent Daily Value (DV) for the Appropriate Nutrients
15. Appendix G: Daily Values for Infants, Children Less Than 4 Years of Age, and Pregnant and Lactating Women
16. Appendix H: Rounding the Values According to the FDA Rounding Rules

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1. Introduction

In a guide such as this, it is impractical to attempt to answer every food labeling question that might arise. The most frequently raised questions have been addressed using a “question and answer” format. We believe the vast majority of food labeling questions are answered. They are grouped by the food labeling area of interest. The Table of Contents will help you locate your food labeling area of interest.

Under FDA's laws and regulations, FDA does not pre-approve labels for food products. Questions concerning the labeling of food products may be directed to
the Food Labeling and Standards Staff (HFS-820), Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Telephone: (301) 436-2371.

2. Background

The Food and Drug Administration (FDA) is responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled. This applies to foods produced domestically, as well as foods from foreign countries. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA's jurisdiction.

The FDA receives many questions from manufacturers, distributors, and importers about the proper labeling of their food products. This guidance is a summary of the required statements that must appear on food labels under these laws and their regulations. To help minimize legal action and delays, it is recommended that manufacturers and importers become fully informed about the applicable laws and regulations before offering foods for distribution in the United States.

The Nutrition Labeling and Education Act (NLEA), which amended the FD&C Act requires most foods to bear nutrition labeling and requires food labels that
bear nutrient content claims and certain health messages to comply with specific requirements. Although final regulations have been established and are reflected in this guidance, regulations are frequently changed. It is the responsibility for the food industry to remain current with the legal requirements for food labeling. All new regulations are published in the Federal Register (FR) prior to their effective date and compiled annually in Title 21 of the Code of Federal Regulations (CFR).

 

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⁽¹⁾ This guidance has been prepared by the Office of Nutritional Products, Labeling, and Dietary Supplements in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

 

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This document supercedes the previous version issued in September 1994.