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  1. Guidance & Regulation (Food and Dietary Supplements)

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

Guidance for Industry

The documents listed below are guidance for the food industry. Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. Manufacturers can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

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Issue Date
(YYYY/MM)
Title Final/
Draft
Category
2024/03 New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements Final Dietary Supplements

2024/02

Foods Derived from Plants Produced Using Genome Editing

Final

Biotechnology 

2024/02

Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE

Draft Seafood
2024/01

Hazard Analysis and Risk-Based Preventive Controls for Human Food

Draft Food Safety (FSMA)
2023/12

Menu Labeling Supplemental Guidance (Edition 2)

Draft Labeling & Nutrition
2023/11

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 - Small Entity Compliance Guide

Draft Labeling & Nutrition
2023/09

Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remain

Final Sanitation & Transportation
2023/09

Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption

Final

Food Safety (FSMA)

2023/09 Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption

Draft

Food Safety (FSMA)

2023/08

The Seafood List - FDA’s Guide to Determine Acceptable Seafood Names

Final

Seafood

2023/07 Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency

Final

Food Safety (FSMA)

2023/07 Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency

Final

Food Safety (FSMA)

2023/06

Action Level for Inorganic Arsenic in Apple Juice

Final

Metals

2023/05 Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide

Final

Food Safety (FSMA)

2023/04 Transition from Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Final

Food Safety (FSMA)

2023/04

Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration Final Labeling & Nutrition

2023/03

Labeling of Infant Formula Final Infant Formula
2023/03 Questions and Answers About Dietary Guidance Statements in Food Labeling

Draft

Labeling & Nutrition

2023/03

Frequently Asked Questions About Medical Foods; Second Edition

Final

Medical Foods

2023/02

Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements Draft

Labeling & Nutrition

2023/02

Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein  Draft

Labeling & Nutrition

2023/01

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

Final

Food Safety (FSMA)

2023/01

Action Levels for Lead in Food Intended for Babies and Young Children Draft

Metals

2022/12

Best Practices for Convening a GRAS Panel

Final Ingredients & Packaging
2022/11

Questions and Answers Regarding Food Allergen Labeling (Edition 5)

Final Allergens
2022/11

Questions and Answers Regarding Food Allergen Labeling (Edition 5)

Draft Allergens
2022/10

Refusal of Inspection by a Foreign Food Establishment or Foreign Government

Final

Food Safety (FSMA)

2022/10 Laboratory Accreditation for Analyses of Foods - What You Need to Know - Small Entity Compliance Guide

Final

Food Safety (FSMA)

2022/09 Prior Notice of Imported Food Questions and Answers (Edition 4)

Final

Food Defense

2022/09

Infant Formula Transition Plan for Exercise of Enforcement Discretion

Final

Infant Formula

2022/08 Policy Regarding N-acetyl-L-cysteine

Final

Dietary Supplements

2022/08 Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House)

Final

Eggs

2022/07

Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (#245)

Final

Food Safety (FSMA)

2022/06 Fish and Fishery Products Hazards and Controls Guidance; Fourth Edition

Final

Seafood

2022/06 Guidance for Food and Drug Administration Staff on FDA Oversight of Food Covered by Systems Recognition Arrangements

Final

System Recognition

2022/05

Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting Final Food Safety (FSMA)

2022/05

Infant Formula Enforcement Discretion Policy Final Infant Formula
2022/04 Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act

Draft

Allergens

2022/04

Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation

Final

Food Safety (FSMA)

2022/04

The Accredited Third-Party Certification Program: Questions and Answers Draft

Food Safety (FSMA)

2022/04

Action Levels for Lead in Juice Draft

Metals

2022/04

Reconditioning of Fish and Fishery Products by Segregation

Final

Seafood

2022/03

Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions Final

Food Safety (FSMA)

2022/03 FDA's Voluntary Qualified Importer Program Final Food Safety (FSMA)
2022/02 Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards Final Food Safety (FSMA)
2022/02 Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues - WITHDRAWN February 2024 Final Pesticides
2021/12 Juice HACCP and the FDA Food Safety Modernization Act Final Food Safety (FSMA)
2021/12 Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act Final Food Safety (FSMA)
2021/12 Seafood HACCP and the FDA Food Safety Modernization Act Final Food Safety (FSMA)
2021/11 Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of Identity Final Labeling & Nutrition
2021/10 Voluntary Sodium Reduction Goals Final Ingredients & Packaging
2021/10 Preparation of Food Contact Substance Notifications: (Toxicology Recommendations) Final Ingredients & Packaging
2021/10 Preparation of Food Contact Substance Notifications (Administrative) Final Ingredients & Packaging
2021/09 Microbiological Considerations for Antimicrobial Agents Used in Food Applications Final Food Additives
2021/07 Use of Recycled Plastics in Food Packaging (Chemistry Considerations) Final Ingredients & Packaging
2021/03 Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period Final Food Safety (FSMA)
2020/12 The Use of an Alternate Name for Potassium Chloride in Food Labeling Final Labeling & Nutrition
2020/11 Prior Notice of Imported Food Contingency Plan for System Outages Final Food Defense
2020/11 Voluntary Disclosure of Sesame as an Allergen Draft Labeling & Nutrition
2020/10 U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration Final Food Safety (FSMA)
2020/08 The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels Final Labeling & Nutrition
2020/05 Action Level for Inorganic Arsenic in Rice Cereals for Infants Final Metals
2020/05 Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency - No longer in effect   Food Safety
2020/05 Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption - No longer in effect   Food Safety (FSMA)
2020/05 Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines - No longer in effect   Labeling & Nutrition
2020/04 Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency - No longer in effect   Eggs
2020/04 Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency - No longer in effect   Labeling & Nutrition
2020/04 Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency - No longer in effect   Labeling & Nutrition
2020/03 Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency - No longer in effect   Labeling & Nutrition
2020/02 Supplemental Mitigation Strategies to Protect Food Against Intentional Adulteration Draft Food Defense
2020/01 Revision of the Nutrition and Supplement Facts Labels; Small Entity Compliance Guide Final Labeling & Nutrition
2019/12 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 Final Labeling & Nutrition
2019/12 Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals Final Labeling & Nutrition
2019/08 Policy Related to Cranberry Products with Added Flavorings Final Labeling & Nutrition
2019/08 Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels Final Labeling & Nutrition
2019/06 Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 Final Food Safety (FSMA)
2019/06 Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Draft Food Safety (FSMA)
2019/06 Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products Final Labeling & Nutrition
2019/05 Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk Final Infant Formula
2019/03 Mitigation Strategies to Protect Food Against Intentional Adulteration Draft Food Defense
2019/03 Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds Final Food Safety (FSMA)
2019/03 Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived from Genetically Engineered Atlantic Salmon Draft Labeling & Nutrition
2019/03 Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants Final Labeling & Nutrition
2018/11 Questions and Answers Regarding Mandatory Food Recalls Final Food Defense
2018/11 Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China Final Import & Exports
2018/11 Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile Final Import & Exports
2018/10 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Draft Food Safety (FSMA)
2018/10 Guide to Minimize Food Safety Hazards of Fresh-cut Produce Draft Food Safety (FSMA)
2018/09 Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food AND Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Final Food Safety (FSMA)
2018/09 Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials Draft Dietary Supplements
2018/08 Questions and Answers Regarding Food Facility Registration (Seventh Edition) Final Food Safety (FSMA)
2018/08 Supplemental Questions and Answers Regarding Food Facility Registration Draft Food Safety (FSMA)
2018/05 Registration of Food Facilities: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide Final Food Safety (FSMA)
2018/05 The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide Final Food Safety (FSMA)
2018/05 Menu Labeling Supplemental Guidance Final Labeling & Nutrition
2018/04 Highly Concentrated Caffeine in Dietary Supplements Final Dietary Supplements
2018/03 Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals Final Food Safety (FSMA)
2018/03 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) Final Labeling & Nutrition
2018/03 Proper Labeling of Honey and Honey Products Final Labeling & Nutrition
2018/03 Reference Amounts Customarily Consumed: List of Products for Each Product Category Final Labeling & Nutrition
2018/03 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 Final Labeling & Nutrition
2018/01 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide Final Food Safety (FSMA)
2018/01 Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities Final Food Safety (FSMA)
2018/01 Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 Draft Food Safety (FSMA)
2018/01 Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs Final Food Safety (FSMA)
2017/12 Refusal of Inspection by a Foreign Food Establishment or Foreign Government Final Food Safety (FSMA)
2017/11 Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide Final Food Safety (FSMA)
2017/11 Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food Final Food Safety (FSMA)
2017/11 Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act Final Ingredients & Packaging
2017/11 Use of the Terms “Brown King Crab” and “Golden King Crab” in the Labeling of Human Food Products Final Seafood
2017/10 Application of the “Solely Engaged” Exemptions in Parts 117 and 507 Draft Food Safety (FSMA)
2017/09 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption - Small Entity Compliance Guide Final Food Safety (FSMA)
2017/08 Mitigation Strategies to Protect Food Against Intentional Adulteration - Small Entity Compliance Guide Final Food Safety (FSMA)
2017/08 Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule Final Food Safety (FSMA)
2017/08 Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products Final Labeling & Nutrition
2017/03 Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation Final Food Safety (FSMA)
2017/01 Control of Listeria monocytogenes in Ready-To-Eat Foods Draft Food Safety (FSMA)
2016/12 Fruit Juice and Vegetable Juice as Color Additives in Food - WITHDRAWN Draft Juice
2016/11 Submitting Forms for Food Canning Establishment Registration and Food Process Filing to FDA in Electronic or Paper Format Final Acidified & Low-Acid Canned Foods
2016/11 What You Need to Know About Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food - Small Entity Compliance Guide Final Food Safety (FSMA)
2016/10 New Dietary Ingredient Notifications and Related Issues Draft Dietary Supplements
2016/10 Frequently Asked Questions about GRAS Final Food Additives
2016/10 Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA Draft Food Safety (FSMA)
2016/09 Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) Final Food Safety (FSMA)
2016/09 Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling Draft Infant Formula
2016/09 Use of the Term “Healthy” in the Labeling of Human Food Products Final Labeling & Nutrition
2016/08 Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities Draft Food Safety (FSMA)
2016/08 Calorie Labeling of Articles of Food in Vending Machines Draft Labeling & Nutrition
2016/08 Calorie Labeling of Articles of Food in Vending Machines - Small Entity Compliance Guide Final Labeling & Nutrition
2016/07 FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels Final Labeling & Nutrition
2016/05 Ingredients Declared as Evaporated Cane Juice Final Labeling & Nutrition
2016/05 Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II Final Labeling & Nutrition
2016/04 Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports Final Infant Formula
2016/03 Acrylamide in Foods Final Chemical Contaminants
2016/02 Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Nutrient Content Claims - Small Entity Compliance Guide Final Labeling & Nutrition
2015/11 Questions and Answers on FDA’s Fortification Policy Final Labeling & Nutrition
2015/09 Colored Sea Salt Final Color Additives
2015/07 Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation Final Eggs
2015/06 Food Allergen Labeling Exemption Petitions and Notifications Final Allergens
2015/03 Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments - Small Entity Compliance Guide Final Labeling & Nutrition
2014/06 Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for "Eligible" Infant Formulas Final Infant Formula
2014/06 Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives Final Ingredients & Packaging
2014/06 Gluten-Free Labeling of Foods - Small Entity Compliance Guide Final Labeling & Nutrition
2014/04 What You Need to Know About Establishment and Maintenance of Records - Small Entity Compliance Guide Final Food Defense
2014/04 FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act Final Food Defense
2014/01 Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format - WITHDRAWN Draft Acidified & Low-Acid Canned Foods
2014/01 Dear Manufacturer Letter Regarding Changes to FDA’s Administration of Process Filings (Forms FDA 2541a and FDA 2541c) for Acidified Foods and Low-Acid Canned Foods Final Acidified & Low-Acid Canned Foods
2014/01 Distinguishing Liquid Dietary Supplements from Beverages Final Dietary Supplements
2014/01 Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements Final Ingredients & Packaging
2013/11 Purchasing Reef Fish Species Associated with the Hazard of Ciguatera Fish Poisoning - WITHDRAWN Final Seafood
2013/09 Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act Final Dietary Supplements
2013/03 What You Need to Know About Administrative Detention of Foods - Small Entity Compliance Guide Final Food Defense
2013/01 Food Labeling Guide Final Labeling & Nutrition
2012/05 Establishing an Allowable Level for di (2-ethylhexyl)phthalate in Bottled Water - Small Entity Compliance Guide Final Bottled Water & Carbonated Soft Drinks
2012/03 Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods Final Salmonella
2012/02 Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) Final Food Defense
2011/12 Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation Final Eggs
2011/11 Letter to Firms that Grow, Harvest, Sort, Pack, Process, or Ship Fresh Cantaloupe Final Produce & Plant Products
2011/10 Evaluating the Safety of Flood-affected Food Crops for Human Consumption Final Produce & Plant Products
2011/10 Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act Final Food Safety (FSMA)
2011/09 Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient Final Salmonella
2011/08 What You Need to Know About Prior Notice of Imported Food Shipments Final Food Defense
2011/06 Enforcement Policy Concerning Certain Prior Notice Requirements - WITHDRAWN Final Food Defense
2011/04 Questions and Answers About the Food Additive or Color Additive Petition Process Final Food Additives
2011/03 Letter to Firms that Grow, Harvest, Sort, Pack, or Ship Fresh Cilantro Final Produce & Plant Products
2010/12 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements - Small Entity Compliance Guide Final Dietary Supplements
2010/11 Safety of Imported Traditional Pottery Intended for Use with Food and the Use of the Term “Lead Free” in the Labeling of Pottery; and Proper Identification of Ornamental and Decorative Ceramicware Final Imports & Exports
2010/10 Food Additive Petition Expedited Review Final Food Additives
2010/09 Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010 - WITHDRAWN Final Labeling & Nutrition
2010/07 Enzyme Preparations: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices Final Food Additives
2010/07 Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed Final Natural Toxins
2010/06 FDA Letter to Industry Concerning Liquid Vitamin D Dietary Supplements Final Dietary Supplements
2010/05 Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory Final Emergency Response
2010/05 Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2) Draft Reportable Food Registry
2010/04 Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage - Small Entity Compliance Guide Final Salmonella
2010/04 Sanitary Transportation of Food Final Sanitation & Transportation
2010/03 Bottled Water and Total Coliform and E. coli - Small Entity Compliance Guide Final Bottled Water & Carbonated Soft Drinks
2010/03 Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety Draft Ingredients & Packaging
2010/03 Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007 Final Reportable Food Registry
2009/10 Letter Regarding Point of Purchase Food Labeling Final Labeling & Nutrition
2009/09 Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act Final Dietary Supplements
2009/09 Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 Final Reportable Food Registry
2009/07 Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices Final Color Additives
2009/07 Draft Guide to Minimize Microbial Food Safety Hazards of Leafy Greens - WITHDRAWN Draft Produce & Plant Products
2009/07 Draft Guide to Minimize Microbial Food Safety Hazards of Melons - WITHDRAWN Draft Produce & Plant Products
2009/07 Draft Guide to Minimize Microbial Food Safety Hazards of Tomatoes - WITHDRAWN Draft Produce & Plant Products
2009/06 Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act Final Dietary Supplements
2009/06 Bottled Water and Residual Disinfectants and Disinfection Byproducts - Small Entity Compliance Guide Final Metals
2009/05 CPG Sec 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 - Compliance Policy Guide Final Food Defense
2009/05 Health Claims on Calcium and Osteoporosis; and Calcium, Vitamin D, and Osteoporosis - Small Entity Compliance Guide Final Labeling & Nutrition
2009/04 Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain These Color Additives - Small Entity Compliance Guide Final Color Additives
2009/04 Bottled Water and Arsenic - Small Entity Compliance Guide Final Metals
2009/04 Bottled Water and Uranium - Small Entity Compliance Guide Final Metals
2009/03 Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions Final Food Additives
2009/03 Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient Final Produce & Plant Products
2009/02 Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association Final Seafood
2009/02 1991 Letter to Seafood Manufacturers Regarding the Fraudulent Practice of Including Glaze (ice) as Part of the Weight of Frozen Seafood Final Seafood
2009/01 Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act Final Dietary Supplements
2009/01 Evidence-Based Review System for the Scientific Evaluation of Health Claims Final Labeling & Nutrition
2008/12 Dear Manufacturer Letter Regarding Front-of-Package Symbols Final Labeling & Nutrition
2008/07 Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk - Small Entity Compliance Guide Final Dietary Supplements
2008/07 Standard of Identity for White Chocolate - Small Entity Compliance Guide Final Food Standards
2008/07 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 Final Labeling & Nutrition
2008/04 Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part I Final Labeling & Nutrition
2008/02 Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables Final Produce & Plant Products
2008/01 Draft Guidance and Protocol for Industry and Food and Drug Administration Staff on Certification of Fish and Fishery Products for Export to the European Union and European Free Trade Association - WITHDRAWN Draft Seafood
2007/12 Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances (Chemistry Recommendations) Final Food Additives
2007/10 Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance - WITHDRAWN Final Food Defense
2007/10 Food Security Preventive Measures Guidance for Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors Final Food Defense
2007/10 Food Security Preventive Measures Guidance for Retail Food Stores and Food Service Establishments Final Food Defense
2007/09 Dear Manufacturer Letter Regarding Sugar Free Claims Final Labeling & Nutrition
2007/07 Redbook 2000: Toxicological Principles for the Safety Assessment of Food Ingredients Final Food Additives
2007/06 Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices Final Juice
2007/05 Small Business Nutrition Labeling Exemption Final Labeling & Nutrition
2007/02 Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT Training Final Food Defense
2007/01 Dear Manufacturer Letter Regarding Food Labeling Final Labeling & Nutrition
2006/11 Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy Final Chemical Contaminants
2006/08 Estimating Dietary Intake of Substances in Food Final Food Additives
2006/06 Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use Final Biotechnology
2006/06 Summary Table of Recommended Toxicological Testing for Additives Used in Food Final Food Additives
2006/05 Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN Final Food Additives
2006/05 FDA's Implementation of Qualified Health Claims Final Labeling & Nutrition
2006/04 Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act - WITHDRAWN Final Labeling & Nutrition
2006/03 Frequently Asked Questions about FDA's Regulation of Infant Formula Final Infant Formula
2006/02 Whole Grain Label Statements Draft Labeling & Nutrition
2005/11 Notice to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles Final Food Defense
2005/11 Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Final Food Defense
2005/09 Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and Cider Final Juice
2005/05 Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations Final Pesticides
2005/04 Dietary Supplement Labeling Guide Final Dietary Supplements
2005/04 Pre-Petition Consultations for Food Additives and Color Additives Final Food Additives
2005/04 Templates for Reporting Toxicology Data Final Food Additives
2005/04 Submitting Requests under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food-Contact Articles Final Food Additives
2005/04 Entry Types and Entry Identifiers - Prior Notice of Imported Food - WITHDRAWN Final Food Defense
2004/10 Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes Final Juice
2004/03 Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition Final Juice
2003/10 Label Warning Statements for Iron-Containing Supplements and Drugs - Small Entity Compliance Guide Final Dietary Supplements
2003/09 Questions and Answers on Juice HACCP Regulation (2003) Final Juice
2003/08 Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims - Small Entity Compliance Guide Final Labeling & Nutrition
2003/07 Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements Final Labeling & Nutrition
2003/06 Standardized Training Curriculum for Application of HACCP Principles to Juice Processing Final Juice
2003/04 Bulk Transport of Juice Concentrates and Certain Shelf-Stable Juices Final Juice
2003/04 Juice HACCP - Small Entity Compliance Guide Final Juice
2002/12 Implementation of Section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)) Regarding the Use of the Term "Catfish" Final Seafood
2002/11 Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned Draft Imports & Exports
2002/10 Exemptions from the Warning Label Requirement for Juice Final Juice
2002/10 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 Final Labeling & Nutrition
2002/10 Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking Final Small Business
2002/06 Channels of Trade Policy for Commodities with Vinclozolin Residues Final Pesticides
2002/01 Structure/Function Claims - Small Entity Compliance Guide Final Dietary Supplements
2001/11 Fumonisin Levels in Human Foods and Animal Feeds Final Natural Toxins
2001/09 Questions and Answers on Juice HACCP Regulation Final Juice
2001/07 Safe Handling Statements on Labeling of Shell Eggs and the Refrigeration of Shell Eggs Held for Retail Distribution - Small Entity Compliance Guide Final Eggs
2001/07 Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin - Small Entity Compliance Guide Final Labeling & Nutrition
2001/07 Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products Final Seafood
2001/01 The FDA Importer's Guide Low-Acid Canned & Acidified Foods - WITHDRAWN Final Acidified & Low-Acid Canned Foods
2000/12 Channels of Trade Policy for Commodities with Methyl Parathion Residues Final Pesticides
2000/08 Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed Final Contaminates
1999/12 Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements - WITHDRAWN Final Labeling & Nutrition
1999/12 Seafood HACCP Transition Guidance Final Seafood
1999/10 Reducing Microbial Food Safety Hazards For Sprouted Seeds - WITHDRAWN Final Produce & Plant Products
1999/10 Sampling And Microbial Testing Of Spent Irrigation Water During Sprout Production - WITHDRAWN Final Produce & Plant Products
1999/07 Antimicrobial Food Additives Final Food Additives
1999/01 Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements - Small Entity Compliance Guide Final Dietary Supplements
1999/01 Questions and Answers on HACCP Regulation for Fish and Fishery Products Final Seafood
1998/10 Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables Final Produce & Plant Products
1998/09 Use of Antibiotic Resistance Marker Genes in Transgenic Plants - WITHDRAWN Draft Biotechnology
1998/06 Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body Final Labeling & Nutrition
1998/05 Food Defect Levels Handbook Final Sanitation & Transportation
1998/03 Guide for Developing and Using Data Bases for Nutrition Labeling Final Labeling & Nutrition
1997/10 Consultation Procedures under FDA's 1992 Statement of Policy for Foods Derived from New Plant Varieties Final Biotechnology
1997/09 Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use - WITHDRAWN Final Food Additives
1997/02 Labeling of Foods that Need Refrigeration by Consumers Final Labeling & Nutrition
1996/06 Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers Final Labeling & Nutrition
1995/06 Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy Wrappers Final Lead
1993/10 Guidelines for Determining Metric Equivalents of Household Measures Final Labeling & Nutrition

 


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