Labeling & Nutrition Guidance Documents & Regulatory Information

General

• 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

• Menu and Vending Machine Labeling Requirements Main Page

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• Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon November 2015
• Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants November 2015

Nutrition Labeling

• 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
• Draft Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products February 2018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
• Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals January 2017
• 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
  • Final Rule on Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids April 2014
• Rules to Update the Nutrition Facts Label
• 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)
• 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)
• 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)
• More on Label Claims
• More on the Front-of-Package Labeling Initiative
  

Allergens

• See Food Allergens Guidance Documents & Regulatory Information.
  

Specific Products

• Beer: Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration (December 2014)
• 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)
• Ultrafiltered Milk: Guidance for Industry: Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese 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

  Biotechnology

  BSE (Mad Cow Disease)

  Eggs/Shell Eggs

  Food Allergens

  Food Irradiation

  "Fresh"

  Gluten-Free

  "Healthy"

  Honey

  Irradiation

  Juice

  "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.