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        Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

Labeling & Nutrition Guidance Documents & Regulatory Information

                        
                Small Business Nutrition Labeling Exemption Home
          Food
          Guidance & Regulation (Food and Dietary Supplements)
          Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
          Labeling & Nutrition Guidance Documents & Regulatory InformationGuidance Documents & Regulatory Information by Topic (Food and Dietary Supplements) Labeling & Nutrition Guidance Documents & Regulatory Information
  	
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**Topics**

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 TopicsAllergens

*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: Menu Labeling Supplemental Guidance May 2018 
	Draft Edition 2 of Menu Labeling Supplemental Guidance
	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 2008Food 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Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon Revised March 2019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 SalmonFood Standards

For additional information, see *Standards of Identity for Food*.

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
	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
	March 2023
	(Constituent Update)
	Final Rule: Revocation of Standard of Identity for **French Dressing** 
	January 2022 
	(Constituent Update)
	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(Constituent Update; Small Entity Compliance Guide)

	Final Rule: Response to Objections and Denial of Public Hearing Requests; Removal of Administrative Stay
		December 2022
		Final Rule: Revocation of Standards for Lowfat and Nonfat Yogurt and Amend the Standard for Yogurt 
		June 2021
	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 ModernizationGeneral 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 GuideJanuary 2013
	Guidelines for Determining Metric Equivalents of Household MeasuresOctober 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 PolicyNovember 2015
	Uniform Compliance Date for Final Food Labeling Regulations Issued in 2021 and 2022 January 2021Inspections, 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 LettersLabel Claims

Letter Regarding Point of Purchase Food LabelingOctober 2009
	Dear Manufacturer Letter Regarding Front-of-Package Symbols December 2008
	Dear Manufacturer Letter Regarding Food LabelingJanuary 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 GuideJanuary 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 AnswersMay 2006
	Evidence-Based Review System for the Scientific Evaluation of Health ClaimsJanuary 2009
	Authorized Health Claims That Meet the Significant Scientific Agreement Standard
	Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and OsteoporosisMay 2009
	*More on Label Claims*Menu and Vending Machine Labeling

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

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
	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
	Draft Guidance for Industry: Whole Grain Label Statements February 2006
	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
	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 1994Additional Information on Specific Topics

**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**

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**Juice**

Questions and Answers: Juice HAACP Regulation**"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

                                                                                  Content current as of:
      12/13/2023
                  
                   
Regulated Product(s)
		 Food & BeveragesTopic(s)
			  LabelingLabeling & Nutrition Guidance Documents & Regulatory Information                
                          

                        Small Business Nutrition Labeling Exemption
 
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