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GUIDANCE DOCUMENT

Guidance for Industry: Food Labeling Guide January 2013

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Human Foods Program

September 1994; Revised April 2008; Revised October 2009; Revised January 2013

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.

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, 5001 Campus Drive, College Park, MD 20740-3835, Telephone: (240) 402-2371.

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).

This document supersedes the previous version issued in October 2009.

Download the Labeling Guide

Resources

Note on Nutrition Labeling

The Food Labeling Guide’s Chapter 7 about Nutrition Labeling is currently under revision and does not reflect all of the most up-to-date labeling requirements.

Until the guide is updated, please refer to the Nutrition Facts label final rule for information about updating nutrition labels. You also can consult FDA’s Industry Resources.

Contact Us

Office of Nutrition and Food Labeling, HFS-800
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
(Tel) 240-402-2373 

Translations

This document 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. The translations are of the October 2009 version. FDA has archived the following translations as they are no longer up to date:

Related Information

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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