Information for Industry

Food Labeling Guidance and Regulations
Compliance & Warning Letters
Food Label Surveys
Inspections, Compliance, Enforcement, Warnings and Recalls
Reporting Problems, Requesting Information
Submitting Comments & Citizens Petitions
Public Meetings & Food Advisory Committees
International Activities & Codex
Other Federal Agency Activities
FDA-DSFL Electronic Newsletter

Food Labeling Guidance and Regulations

• Code of Federal Regulations, Part 101 - Food Labeling
• Guidance for Industry: A Food Labeling Guide. April 2008
• Food Labeling Guidance Documents
• Guidance for Industry: A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods April 2008
• Nutrition Information on Restaurant Menus. FDA Talk Paper July 30, 1996
• Small Business
  • Small Business Nutrition Labeling Exemption. (Introduction, Model Form and Instructions) October 1, 2004; Updated May 7, 2007
    • Web-based Submission
    • Small Business Labeling Exemption Requests. (List of firms)
  • 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)
• Labeling of Raw Fruits, Vegetables and Fish
  • Food Labeling: Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish
    • Correction Notice, 71 FR 47439 August 17, 2006
    • Final Rule, 71 FR 42031 July 25, 2006
  • Voluntary Point-of-Purchase Tool for Retail Stores: Nutrition Information for Raw Fruits, Vegetables, and Fish - Downloadable/Printable Posters December 21, 2007

• Nutrition Labeling Final and Proposed Rules
  • Notice of Proposed Rulemaking: Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids November 27, 2007
  • Advance Notice of Proposed Rulemaking: Revision of Reference Values and Mandatory Nutrients November 2, 2007
  • Final Rule: Food Labeling, Nutrient Content Claims Definition of Sodium Levels for The Term "Healthy" September 29, 2005
  • Advance Notice of Proposed Rulemaking: Prominence of Calories April 4, 2005
  • Advance Notice of Proposed Rulemaking: Serving Sizes April 4, 2005
• 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, Warning, and Other Letters

• Guidance for Industry: Dear Manufacturer Letter Regarding Front-of-Package Symbols December 2008
• Guidance for Industry and FDA: Dear Manufacturer Letter Regarding Food Labeling January 30, 2007
• FDA Warns Companies To Stop Marketing Fruit Products With Unproven Disease Treatment and Prevention Claims October 24, 2005
  • List of Firms Receiving Warning Letters
  • Sample Warning Letter October 17, 2005
• Letter to Food Manufacturers about "And/Or" Ingredient Labeling of Nutritive Sweeteners in Soft Drink Products July 5, 2005
• Letter to Food Manufacturers about Accurate Serving Size Declaration on Food Products March 12, 2004
• 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. Alcohol and Tobacco Tax and Trade Bureau (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