Labeling & Nutrition Guidance Documents & Regulatory Information
Labeling & Nutrition Main Section
On this page:
- General and Related Information
- Label Claims
- Nutrition and Food Labeling
- Specific Topics
- Food Standards
- Inspections, Compliance, Enforcement, & Recalls
- Code of Federal Regulations (CFR): Title 21 - Food and Drugs - Part 101--Food Labeling
- Fair Packaging and Labeling Act of 1966
- Federal Food, Drug, and Cosmetic Act Chapter IV: Food
- Guidelines for Determining Metric Equivalents of Household Measures
- Questions and Answers on FDA’s Fortification Policy
- Uniform Compliance Date for Food Labeling Regulations Published From January 1, 2025 To December 31, 2026
- Letter of Enforcement Discretion to GMA/FMI re "Facts Up Front December 2011
- 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 2002
- Dear Manufacturer Letter Regarding Sugar Free Claims September 2007
- 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 2003
- FDA's Implementation of "Qualified Health Claims": Questions and Answers May 2006
- Evidence-Based Review System for the Scientific Evaluation of Health Claims January 2009
- Authorized Health Claims That Meet the Significant Scientific Agreement Standard
- Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis May 2009
For more information, see Label Claims.
- Food Labeling Guide
- Proposed Rule: Front of Package Labeling January 2025
- Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods January 2025
- Small Entity Compliance Guide: Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt November 2023
- Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration April 2023
- Draft Guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food Labeling March 2023
- Draft Guidance for Industry: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements February 2023
- Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling December 2020
- Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels October 2020
- Guidance for Industry: Revision of the Nutrition and Supplement Facts Labels; Small Entity Compliance Guide January 2020
- 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 December 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 Revised December 2019
- Guidance for Industry: Policy Related to Cranberry Products with Added Flavorings August 2019
- 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
- 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: Proper Labeling of Honey and Honey Products March 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: 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: Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products August 2017
- Guidance for Industry: FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels July 2016
- Guidance for Industry: Ingredients Declared as Evaporated Cane Juice May 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
- Guidance for Industry: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain Cochineal Extract and Carmine; Small Entity Compliance Guide April 2009
- Small Business Nutrition Labeling Exemption Guide October 1, 2004; Updated May 2007
- Draft Guidance for Industry: Whole Grain Label Statements February 2006
- Proposed Rule: Ultrafiltered Milk in Cheeses and Related Cheese Products October 2005
- Small Entity Compliance Guide: Iron-Containing Supplements and Drugs October 2003
- Guidance for Industry (Small Entity Compliance Guide): Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims August 2003
- Final Rule: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims July 2003
- Guidance for Industry: Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance Guide; Small Entity Compliance Guide July 2001
- Final Rule: Procedures for the Safe and Sanitary Processing and Importing of Juice January 2001
- FDA Nutrition Labeling Manual -- A Guide for Developing and Using Data Bases March 1998
- Guidance for Industry: Labeling of Foods that Need Refrigeration by Consumers February 1997
- Interim Guidance: Voluntary Labeling of Milk and Milk Products that have not been treated with Recombinant Bovine Somatropin (59 FR 6279) February 1994
Allergens
Away-From-Home Foods Including Menu and Vending Machine Labeling
- Guidance for Industry: Menu Labeling Supplemental Guidance May 2018
- 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
For more information, see the Menu and Vending Machine Labeling Requirements Main Page.
BSE (Mad Cow Disease)
- Bovine Spongiform Encephalopathy (BSE) (Includes background, consumer information, FDA Action Plan, industry information, latest actions)
Cultured Seafood Cells
- Request for Information: Labeling of Foods Comprised of or Containing Cultured Seafood Cells
- Food Made with Cultured Animal Cells
Eggs/Shell Eggs
Food From Genetically Engineered Plants and 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
Food Irradiation
- Final Rule: Irradiation in the Production, Processing and Handling of Food November 2012
- Guidance for Industry: Implementation of Section 10809 of the Farm Security and Investment Act of 2002 Regarding the Petition Process to Request Approval of Labeling for Foods That Have Been Treated with Irradiation
- Proposed Rule: Irradiation in the Production, Processing, and Handling of Food April 2007
- Advanced Notice of Proposed Rule Making: Irradiation in the Production, Processing, and Handling of Food February 1999
"Fresh"
"Gluten-Free"
"Healthy"
Infant Formula
Juice
"Natural"
Organic
Sodium
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
- Nutrition Information for Raw Fruits, Vegetables, and Fish - Downloadable/Printable Posters December 2007
Trans Fatty Acids
- Small Entity Compliance Guide: Revocation of Uses of Partially Hydrogenated Oils in Foods April 2024
- Final Rule: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims July 2003
- Guidance for Industry (Small Entity Compliance Guide): Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims August 2003
- Advanced Notice of Proposed Rule Making: Trans Fatty Acids in Nutrition Labeling: Consumer Research to Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements July 2003
For additional information, see Standards of Identity for Food.
- Final Rule: Revocation of Standard of Identity and Standard of Quality for Frozen Cherry Pie | Constituent Update
March 2024 - Inventory of Temporary Marketing Permits Granted under 21 U.S.C. 341 for Definitions and Standards of Identity for Food
- Proposed Rule: Canned Tuna Standard of Identity and Standard of Fill of Container | Constituent Update
August 2023 - Proposed Rule Pre-Publication Text: Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods | Constituent Update
March 2023 - Final Rule: Revocation of Standard of Identity for French Dressing | Constituent Update
January 2022 - Final Order: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt
April 2023 - Proposed Rule: Use of Ultrafiltered Milk | Constituent Update
October 2005 - Advance Notice of Proposed Rulemaking: Standards of Identity for Frozen Desserts and Parmesan Cheese
September 2005 - Final Rule: Establishment of Standard of Identity for White Chocolate
October 2002 - Withdrawn Proposed Rule: General Principles and Food Standards Modernization
- 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 warning letters and other letters, see the FOIA Electronic Reading Room and FDA Warning Letters