Food
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Labeling & Nutrition Guidance Documents & Regulatory Information
Guidance for Industry
Guidance documents contain nonbinding recommendations.
General
- A Food Labeling Guide (October 2009) - This document also available en Español (Spanish), لعربية (Arabic PDF, 1.29MB), हिंदी (Hindi PDF, 1.46 MB), 中国 (Simplified Chinese PDF, 2.85MB),日本 (Japanese PDF, 1.23MB)
- Retail Labeling: A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods (April 2008)
- Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims; Small Entity Compliance Guide (August 20, 2003)
- Guidelines for Determining Metric Equivalents of Household Measures (October 1, 1993)
- Guidance for Industry: Ingredients Declared as Evaporated Cane Juice; Draft Guidance (October 2009)
- Code of Federal Regulations (CFR): Title 21 - Food and Drugs - Part 101--Food Labeling
Menu and Vending Machine Labeling
Nutrition Labeling
- Small Business Nutrition Labeling Exemption (October 1, 2004; Updated May 7, 2007)
- FDA Nutrition Labeling Manual -- A Guide for Developing and Using Data Bases (March 1998)
Label Claims
- Letter Regarding Point of Purchase Food Labeling (October 2009)
- Dear Manufacturer Letter Regarding Front-of-Package Symbols (December 2008)
- Dear Manufacturer Letter Regarding Food Labeling (January 2007)
- Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (July 1998)
- Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002)
- Nutrient Content Claims: Dear Manufacturer Letter Regarding Sugar Free Claims (September 2007)
- Nutrient Content Definitions: Food Labeling; Nutrient Content Claims; Definition for "High Potency" and Definition for "Antioxidant" for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods Small Entity Compliance Guide (July 2008)
Health Claims
- Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (July 10, 2003)
- FDA's Implementation of "Qualified Health Claims": Questions and Answers (May 12, 2006)
- Evidence-Based Review System for the Scientific Evaluation of Health Claims (January 2009)
- Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999)
- Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis (May 2009)
Allergens
- Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4) (October 2006)
- Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers (June 10, 1996)
Specific Products
- Beer: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration; Draft Guidance (August 2009)
- Juice: Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively Achieving a 5-Log Pathogen Reduction (October 7, 2002)
- Milk: Interim Guidance on the Voluntary Labeling of Milk and Milk Products that have not been treated with Recombinant Bovine Somatropin (59 FR 6279, February 10, 1994)
- Shell Eggs: Food Labeling - Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution Small Entity Compliance Guide (July 2001)
- WITHDRAWN: Soy Lecithin: Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act (April 2006)
- White Chocolate: Standard of Identity for White Chocolate; Small Entity Compliance Guide (July 17, 2008)
- Whole Grain: Draft Guidance: Whole Grain Label Statements (February 2006)
- Biotechnology: Draft Guidance: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering (January 2001)
- Irradiation: Implementation of Section 10809 of the Farm Security and Investment Act of 2002, Pub. L. No. 107-171, § 10809 (2002) regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated by Irradiation.
- Label Warning Statements: Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 17, 2003)
- Refrigeration: Guidance on Labeling of Foods that Need Refrigeration by Consumers (62 FR 8248, February 24, 1997)
- Serving Size: Food Labeling - Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance Guide (July 2001)
- Topic-Specific Labeling Information covering:
Adding Novel Ingredients to Conventional Foods
AquAdvantage Salmon
Biotechnology
BSE (Mad Cow Disease)
Eggs/Shell Eggs
Food Allergens
Food Irradiation
"Fresh"
Gluten-Free
Juice
Trans Fatty Acids
Foods Needing Refrigeration
Raw Fruits, Vegetables and Fish
Food Standards
Inspections, Compliance, Enforcement, & Recalls
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FDA Inspection References (Manuals and other documents that provide procedures and guidance to FDA personnel for conducting their inspection and investigation activities)
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FDA Compliance References (Compliance Policy Guides and Regulatory Procedure Manual)
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Imports and Exports (Procedures, Compliance Programs, Import Alerts, Detentions)
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FDA Recalls and Safety Alerts (Policies, Enforcement Reports, Alerts)
Warning & Other Letters
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Letter to General Mills Concerning Cheerios® Toasted Whole Grain Oat Cereal Labeling May 3, 2012
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FDA Response to General Mills Addressing the Scientific Basis for Cheerios Cholesterol Claims October 9, 2009
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Letter to Food Manufacturers about "And/Or" Ingredient Labeling of Nutritive Sweeteners in Soft Drink Products July 5, 2005
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Sample Letter to Food Manufacturers about Accurate Serving Size Declaration on Food Products March 12, 2004
For additional warning letters and other letters, see the CFSAN FOIA Electronic Reading Room and FDA Warning Letters.
For questions regarding this information contact the Center for Food Safety and Applied Nutrition 240-402-2371.
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Color Additive Guidance
Food Labeling
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