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

• See Food Allergens Guidance Documents & Regulatory Information.

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• Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon Revised March 2019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
  • Information on Genetically Engineered Salmon

Food Standards

• Inventory of Temporary Marketing Permits Granted under 21 U.S.C. 341 for Definitions and Standards of Identity for Food 

  • 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

• Proposed Rule Pre-Publication Text: Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods
  March 2023
  (Constituent Update) 

• Final Rule: Revocation of Standard of Identity for French Dressing 
  January 2022 
  (Constituent Update)

• Final Rule: Revocation of Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt 
  June 2021
  (Constituent Update)

  • Certain Provisions of Yogurt Standard of Identity Final Rule Have Been Stayed March 2022

• Proposed Rule: Proposed Revocation of Standard of Identity and Standard of Quality for Frozen Cherry Pie 
  December 2020 
  (Constituent Update)

• Proposed Rule: Use of Ultrafiltered Milk 
  October 2005 
  (Constituent Update) 

• 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

  • Small Entity Compliance Guide: Standard of Identity for White Chocolate
    July 2008

• Withdrawn Proposed Rule: General Principles and Food Standards Modernization

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

• See Away-From-Home Foods Including Menu and Vending Machine Labeling

Nutrition and Food Labeling

• 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: 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
  • 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 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"

• Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims: Fresh, Freshly Frozen, Fresh Frozen, Frozen Fresh

"Gluten-Free"

• Food Allergens and Gluten-Free Guidance Documents and Regulatory Information

"Healthy"

• Use of the Term Healthy on Food Labeling

Infant Formula 

• Infant Formula Guidance Documents & Regulatory Information

Honey

• Guidance for Industry: Proper Labeling of Honey and Honey Products March 2018

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

• Guidance for Industry: Labeling of Foods that Need Refrigeration by Consumers February 1997

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
  • Reopening of the Comment Period on the Proposed Rule to Permit the Use of Ultrafiltered Milk in Cheeses and Related Cheese Products December 2019 and March 2020
• Interim Guidance: Voluntary Labeling of Milk and Milk Products that have not been treated with Recombinant Bovine Somatropin (59 FR 6279) February 1994

"Natural"

• Use of the Term "Natural" on Food Labeling

Organic

• Use of the Term "Organic" on Food Labels

Sodium 

• Sodium Reduction

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

• 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

• Draft Guidance for Industry: Whole Grain Label Statements February 2006