Information for Industry

Food Labeling, Guidance and Regulations

• Code of Federal Regulations, Part 101 - Food Labeling
• A Food Labeling Guide. September 1994. Editorial revisions June 1999 (summary of statements required on food labels, questions and answers, guides and tables)
  • Appendix A, "Definitions of Nutrient Content Claims"
  • Appendix B, "Relative (or Comparative) Claims"
  • Appendix C, "Health Claims"
  • Reference Values for Nutrition Labeling Revised January 1998
• Labeling Questions & Answers: Vol #1. (Nutrition, Servings, Claims, Juice and Ingredients) August 1993
• Labeling Questions & Answers: Vol #2 (A Guide for Restaurants and Other Retail Establishments.) Revised February 1996
• Nutrition Information on Restaurant Menus. FDA Talk Paper July 30, 1996
• Small Business
  • Small Business Food Labeling Exemption. (Introduction, Model Form and Instructions) March 22, 2000
  • Small Business Labeling Exemption Requests. (List of firms) December 31, 2003
  • Small Entity Compliance Guides, Food and Cosmetic Guidance Documents
    • Food labeling serving sizes, shell eggs, juice, baking soda, etc.
• FDA Nutrition Labeling Manual - A Guide for Developing and Using Databases (1998 Edition)

• FDA Federal Register Documents, Code of Federal Regulations & Food, Drug, and Cosmetic Act includes:
  • Federal Register (FR): FDA FR documents published March 2, 1998 to present, FR search 1995 to present via GPO Access, and How to Obtain copies of FR and CFR
  • Dockets Management Home Page
  • Compilation of Laws Enforced by FDA (e.g., Food, Drug, and Cosmetic Act, Fair Packaging and Labeling Act, Food and Drug Administration Modernization Act)
  • Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking

• Health & Nutrient Content Claims (includes general information, tables of claims and specific health and nutrient content claims)

• Specific Topics and Categories (food allergens, biotechnology, botanicals and novel ingredients, BSE - "Mad Cow" Disease, eggs, "fresh", irradiation, juice, labeling of foods needing refrigeration, trans fatty acids, and white chocolate)

• Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food (21 CFR 110)

Compliance and Warning Letters

• FDA Letter on Labeling Food Products Presented or Available on the Internet (this includes Dietary Supplements) (also available in PDF) November 1, 2001
• FDA Sends Warning Letters To Manufacturers Concerning The Addition Of Herbal Ingredients To Beverages, June 4 - 5, 2001.
• FOIA Warning Letters Search

Food Label Surveys

• Overview and Methodology of FDA Food Label and Package Survey (FLAPS), 2000-2001

Inspections, Compliance, Enforcement, Warnings and Recalls

• FDA Inspection References (Manuals and other documents that provide procedures and guidance to FDA personnel for conducting their inspection and investigation activities)
• FDA Compliance References (Compliance Policy Guides and Regulatory Procedure Manual)
• Imports and Exports (Procedures, Compliance Programs, Import Alerts, Detentions)
• FDA Recalls and Safety Alerts (Policies, Enforcement Reports, Alerts)
• Information Materials for the Food and Cosmetic Industries: Food Labeling Publications (includes guidance documents, methods book, guidelines for household measures)

Reporting Problems, Requesting Information
Submitting Comments and Citizen Petitions

• FDA Problem Reporting (Includes list of consumer complaint coordinators, and how and when to report)
• Handbook for Requesting Information and Records from FDA March 28, 1997; Updated March 28, 1999; Updated October 12, 1999 (Freedom of Information Requests)
• Making Your Voice Heard at FDA: How to Comment on Proposed Regulations and Submit Petitions (Citizen Petitions) June 11, 2001

Public Meetings & Food Advisory Committees

• Public Meetings, Advisory Committees, and Dockets Management
  Includes FDA Advisory Committees, USDA/FSIS National Advisory Committee on Microbiological Criteria for Foods
• Notice of Meeting: Nutrition Subcommittee of the Food Advisory Committee April 27-28, 2004

International Activities and Codex

• Food and Cosmetics International Activities (includes Codex)

Other Federal Agency Activities

• Federal Trade Commission
  • FTC Models Advertising Policy On FDA Food Labeling Standards. September 1994
  • Enforcement Policy Statement on Food Advertising May 1994
• The National Academies Institute of Medicine Recent Food and Nutrition Board Reports. (Includes upper intake levels of nutrients, B Vitamins, Calcium and other minerals.)
• National Institutes of Health (NIH)
  • Office of Dietary Supplements
    • Facts About Dietary Supplements (Fact Sheets on Vitamins, Minerals, etc.)
• U.S. Bureau of Alcohol, Tobacco and Firearms, Publications (liquor labeling)
• U.S. Customs, Importing and Exporting
• U.S. Department of Agriculture (USDA)
  • Center for Nutrition Policy and Promotion
  • Food Safety Inspection Service (FSIS)
    • Office of Policy, Program Development and Evaluation, Labeling and Consumer Protection Staff
  • Agricultural Research Service, Nutrient Data Laboratory (includes USDA Nutrient Database for Standard Reference)

FDA-DSFL Electronic Newsletter

• How to Subscribe to the Dietary Supplement and Food Labeling Electronic Newsletter or Obtain Past Issues