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), Arabic (PDF: 1.29MB), Hindi (PDF: 1.46 MB), Simplified Chinese (PDF: 2.85MB), and Japanese (PDF: 1.23MB).
- 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 Requirements
- Menu and Vending Machine Labeling Requirements Main Page
- Draft Guidance for Industry: Calorie Labeling of Articles of Food in Vending Machines (August 2016)
- Guidance for Industry: Calorie Labeling of Articles of Food in Vending Machines; Small Entity Compliance Guide (August 2016)
- Guidance for Industry: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Small Entity Compliance Guide March 2015
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- Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon November 2015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
- Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative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
- Draft Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category January 2017
- Draft Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as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) November 2016
- 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 (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
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)
Warning & Other Letters
- Letter to General Mills Concerning Cheerios® Toasted Whole Grain Oat Cereal Labeling May 3, 2012
- FDA Response to General Mills Addressing the Scientific Basis for Cheerios Cholesterol Claims October 9, 2009
- Letter to Food Manufacturers about "And/Or" Ingredient Labeling of Nutritive Sweeteners in Soft Drink Products July 5, 2005
- 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.