Labeling & Nutrition Guidance Documents & Regulatory Information
Labeling & Nutrition Guidance Documents & Regulatory Information
General
- Draft Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling May 2019
- A Food Labeling Guide (January 2013)
- 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: Questions and Answers on FDA’s Fortification Policy (November 2015)
- Guidance for Industry: Ingredients Declared as Evaporated Cane Juice (May 2016)
- Code of Federal Regulations (CFR): Title 21 - Food and Drugs - Part 101--Food Labeling
Menu and Vending Machine Labeling
Away-From-Home Foods
- Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11) (April 2016)
- Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part I (April 2008)
Food From Genetically Engineered Plants & Atlantic Salmon
- Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon Revised March 2019
- Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants Revised March 2019
Nutrition Labeling
- Guidance for Industry: Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels August 2019
- Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products June 2019
- Draft Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels April 2019
- Guidance for Industry: Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals November 2018
- Draft Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics November 2018
- Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels June 2018
- Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30) February 2018
- Guidance for Industry: Proper Labeling of Honey and Honey Products February 2018
- Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category February 2018
- Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Small Entity Compliance Guide February 2018
- Guidance for Industry: FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels July 2016
- Guidance for Industry: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Small Entity Compliance Guide February 2016
- Rules to Update the Nutrition Facts Label
- Small Business Nutrition Labeling Exemption Guide (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)
- Dear Manufacturer Letter Regarding Sugar Free Claims (September 2007)
- 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)
- 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)
- Authorized Health Claims That Meet the Significant Scientific Agreement Standard
- Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis (May 2009)
- More on Label Claims
- More on the Front-of-Package Labeling Initiative
Allergens
Specific Products
- Label Warning Statements: Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 17, 2003)
- Serving Size: 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
- Beer
- Biotechnology
- BSE (Mad Cow Disease)
- Eggs/Shell Eggs
- Food Allergens
- Food Irradiation
- "Fresh"
- Gluten-Free
- "Healthy"
- Honey
- Irradiation
- Juice
- Milk
- "Natural"
- Trans Fatty Acids
- White Chocolate
- Foods Needing Refrigeration
- Raw Fruits, Vegetables and Fish
- Refrigeration
- Shell Eggs
- Whole Grain
- Food Standards
Inspections, Compliance, Enforcement, & Recalls
- Inspection References (Manuals and other documents that provide procedures and guidance to FDA personnel for conducting their inspection and investigation activities)
- 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)
For additional warning letters and other letters, see the CFSAN FOIA Electronic Reading Room and FDA Warning Letters.