Labeling & Nutrition Guidance Documents & Regulatory Information
Labeling & Nutrition Main Section
Topics
- Temporary Policy Related to COVID-19
- Allergens
- Away-From-Home Foods Including Menu and Vending Machine Labeling
- Food From Genetically Engineered Plants and Atlantic Salmon
- Food Standards
- General and Related Information
- Inspections, Compliance, Enforcement, & Recalls
- Label Claims
- Menu and Vending Machine Labeling
- Nutrition and Food Labeling
- Specific Topics
Temporary Policy Related to COVID-19
- Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines May 2020
- Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency April 2020
- Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency April 2020
- Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency March 2020
Allergens
Away-From-Home Foods Including Menu and Vending Machine Labeling
- Menu and Vending Machine Labeling Requirements Main Page
- Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines May 2020
- Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency April 2020
- 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 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- Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon Revised March 2019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 Standards
- Cheeses and Related Cheese Products: Proposed Rule: Use of Ultrafiltered Milk October 2005
- Food Standards: Guidance for Industry: Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of Identity November 2021
- Food Standards: Inventory of Temporary Marketing Permits Granted under 21 U.S.C. 341 for Definitions and Standards of Identity for Food April 2015
- Food Standards: Proposed Rule: General Principles and Food Standards Modernization May 2005 and extension of the reopened comment period on the proposed rule April 2020
- French Dressing: Revocation of a Standard of Identity (January 2022)
- Frozen Cherry Pie: Proposed Rule: Frozen Cherry Pie; Proposed Revocation of a Standard of Identity and a Standard of Quality December 2020
- Frozen Desserts and Parmesan Cheese: Advance Notice of Proposed Rulemaking: Standards of Identity for Frozen Desserts and Parmesan Cheese September 2005
- White Chocolate: Guidance for Industry (Small Entity Compliance Guide): Standard of Identity for White Chocolate July 2008
- Yogurt: Final Rule: Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt June 2021
General and Related Information
- 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
- Food Labeling Guide January 2013
- Guidelines for Determining Metric Equivalents of Household Measures October 1993
- 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
- Questions and Answers on FDA’s Fortification Policy November 2015
- Uniform Compliance Date for Final Food Labeling Regulations Issued in 2021 and 2022 January 2021
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 warning letters and other letters, see the CFSAN FOIA Electronic Reading Room and FDA Warning Letters
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 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
- More on Label Claims
Menu and Vending Machine Labeling
Nutrition and Food Labeling
- 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: 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: 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 2007
- Guidance for Industry: Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance Guide; Small Entity Compliance Guide (July 2001)
- FDA Nutrition Labeling Manual -- A Guide for Developing and Using Data Bases March 1998
Specific Topics
Beer
- Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration December 2014
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
- Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency
- Guidance for Industry: Refrigeration of Shell Eggs Held for Retail Distribution
- Eggs Guidance Documents & Regulatory Information
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
Honey
Juice
- Guidance for Industry: Ingredients Declared as Evaporated Cane Juice May 2016
- Final Rule: Procedures for the Safe and Sanitary Processing and Importing of Juice January 2001
- Questions and Answers: Juice HAACP Regulation August 2001 (includes labeling questions)
Labeling of Foods Needing Refrigeration
Milk and Milk Products
- Final Rule: Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt June 2021
- Guidance for Industry: Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products August 2017
- Proposed Rule: Ultrafiltered Milk in Cheeses and Related Cheese Products October 2005
- Interim Guidance: Voluntary Labeling of Milk and Milk Products that have not been treated with Recombinant Bovine Somatropin (59 FR 6279) February 1994
"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
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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
Warning Statements
- Guidance for Industry (Small Entity Compliance Guide): Iron-Containing Supplements and Drugs October 2003
Whole Grains