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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)
TitleFinal/
Draft
Category
2025/01Questions and Answers Regarding Food Allergen Labeling (Edition 5)Final (revised)Allergens
2025/01Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic ActFinalAllergens
2025/01Labeling of Plant-Based Alternatives to Animal-Derived FoodsDraftLabeling & Nutrition
2025/01Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination EventDraftFood Safety (FSMA)
2025/01Action Levels for Lead in Processed Food Intended for Babies and Young ChildrenFinalMetals
2024/12Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant FormulaDraftInfant Formula
2024/11FDA's Voluntary Qualified Importer ProgramFinalImports & Exports
2024/08Voluntary Sodium Reduction Goals (Edition 2)DraftIngredients & Packaging
2024/04Revocation of Uses of Partially Hydrogenated Oils in Foods - Small Entity Compliance GuideFinalIngredients & Packaging
2024/04New Dietary Ingredient Notification Master Files for Dietary SupplementsDraftDietary Supplements
2024/04New Dietary Ingredient Notifications and Related Issues (Revised Draft) DraftDietary Supplements
2024/03New Dietary Ingredient Notification Procedures and Timeframes - Dietary SupplementsFinalDietary Supplements
2024/02Foods Derived from Plants Produced Using Genome EditingFinalBiotechnology 
2024/02Recommendations 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 DWPEDraftSeafood
2024/01Hazard Analysis and Risk-Based Preventive Controls for Human FoodDraftFood Safety (FSMA)
2023/12Menu Labeling Supplemental Guidance (Edition 2)DraftLabeling & Nutrition
2023/11Milk 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 GuideDraftLabeling & Nutrition
2023/09Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human RemainFinalSanitation & Transportation
2023/09Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human ConsumptionFinalFood Safety (FSMA)
2023/09Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human ConsumptionDraftFood Safety (FSMA)
2023/08The Seafood List - FDA’s Guide to Determine Acceptable Seafood NamesFinalSeafood
2023/07Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health EmergencyFinalFood Safety (FSMA)
2023/07Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health EmergencyFinalFood Safety (FSMA)
2023/06Action Level for Inorganic Arsenic in Apple JuiceFinalMetals
2023/05Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation - Small Entity Compliance GuideFinalFood Safety (FSMA)
2023/04Transition 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 ConsumptionFinalFood Safety (FSMA)
2023/04Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug AdministrationFinalLabeling & Nutrition
2023/03Labeling of Infant FormulaFinalInfant Formula
2023/03Questions and Answers About Dietary Guidance Statements in Food LabelingDraftLabeling & Nutrition
2023/03Frequently Asked Questions About Medical Foods; Second EditionFinalMedical Foods
2023/02Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient StatementsDraftLabeling & Nutrition
2023/02Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein DraftLabeling & Nutrition
2023/01Foreign Supplier Verification Programs for Importers of Food for Humans and AnimalsFinalFood Safety (FSMA)
2022/12Best Practices for Convening a GRAS PanelFinalIngredients & Packaging
2022/10Refusal of Inspection by a Foreign Food Establishment or Foreign GovernmentFinalFood Safety (FSMA)
2022/10Laboratory Accreditation for Analyses of Foods - What You Need to Know - Small Entity Compliance GuideFinalFood Safety (FSMA)
2022/09Prior Notice of Imported Food Questions and Answers (Edition 4)FinalFood Defense
2022/09Infant Formula Transition Plan for Exercise of Enforcement DiscretionFinalInfant Formula
2022/08Policy Regarding N-acetyl-L-cysteineFinalDietary Supplements
2022/08Questions 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)FinalEggs
2022/07Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (#245)FinalFood Safety (FSMA)
2022/06Fish and Fishery Products Hazards and Controls Guidance; Fourth EditionFinalSeafood
2022/06Guidance for Food and Drug Administration Staff on FDA Oversight of Food Covered by Systems Recognition ArrangementsFinalSystem Recognition
2022/05Reducing Microbial Food Safety Hazards in the Production of Seed for SproutingFinalFood Safety (FSMA)
2022/05Infant Formula Enforcement Discretion PolicyFinalInfant Formula
2022/04Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers RegulationFinalFood Safety (FSMA)
2022/04The Accredited Third-Party Certification Program: Questions and AnswersDraftFood Safety (FSMA)
2022/04Action Levels for Lead in JuiceDraftMetals
2022/04Reconditioning of Fish and Fishery Products by SegregationFinalSeafood
2022/03Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain ProvisionsFinalFood Safety (FSMA)
2022/02Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation StandardsFinalFood Safety (FSMA)
2021/12Juice HACCP and the FDA Food Safety Modernization ActFinalFood Safety (FSMA)
2021/12Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization ActFinalFood Safety (FSMA)
2021/12Seafood HACCP and the FDA Food Safety Modernization ActFinalFood Safety (FSMA)
2021/11Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of IdentityFinalIngredients & Packaging
2021/10Voluntary Sodium Reduction GoalsFinalIngredients & Packaging
2021/10Preparation of Food Contact Substance Notifications: (Toxicology Recommendations)FinalIngredients & Packaging
2021/10Preparation of Food Contact Substance Notifications (Administrative)FinalIngredients & Packaging
2021/09Microbiological Considerations for Antimicrobial Agents Used in Food ApplicationsFinalFood Additives
2021/07Use of Recycled Plastics in Food Packaging (Chemistry Considerations)FinalIngredients & Packaging
2021/03Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal PeriodFinalFood Safety (FSMA)
2020/12The Use of an Alternate Name for Potassium Chloride in Food LabelingFinalLabeling & Nutrition
2020/11Prior Notice of Imported Food Contingency Plan for System OutagesFinalFood Defense
2020/11Voluntary Disclosure of Sesame as an AllergenDraftLabeling & Nutrition
2020/10U.S. Agent Voluntary Identification System (VIS) for Food Facility RegistrationFinalFood Safety (FSMA)
2020/08The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts LabelsFinalLabeling & Nutrition
2020/08Action Level for Inorganic Arsenic in Rice Cereals for InfantsFinalMetals
2020/02Supplemental Mitigation Strategies to Protect Food Against Intentional AdulterationDraftFood Defense
2020/01Revision of the Nutrition and Supplement Facts Labels; Small Entity Compliance GuideFinalLabeling & Nutrition
2019/12Serving 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 TopicsFinalLabeling & Nutrition
2019/12Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and MineralsFinalLabeling & Nutrition
2019/08Policy Related to Cranberry Products with Added FlavoringsFinalLabeling & Nutrition
2019/08Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts LabelsFinalLabeling & Nutrition
2019/06Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507FinalFood Safety (FSMA)
2019/06Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionDraftFood Safety (FSMA)
2019/06Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry ProductsFinalLabeling & Nutrition
2019/05Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human MilkFinalInfant Formula
2019/03Mitigation Strategies to Protect Food Against Intentional AdulterationDraftFood Defense
2019/03Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and AlmondsFinalFood Safety (FSMA)
2019/03Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived from Genetically Engineered Atlantic SalmonDraftLabeling & Nutrition
2019/03Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered PlantsFinalLabeling & Nutrition
2018/11Questions and Answers Regarding Mandatory Food RecallsFinalFood Defense
2018/11Establishing 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 ChinaFinalImport & Exports
2018/11Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to ChileFinalImport & Exports
2018/10Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionDraftFood Safety (FSMA)
2018/10Guide to Minimize Food Safety Hazards of Fresh-cut ProduceDraftFood Safety (FSMA)
2018/09Determination 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 AnimalsFinalFood Safety (FSMA)
2018/09Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live MicrobialsDraftDietary Supplements
2018/08Questions and Answers Regarding Food Facility Registration (Seventh Edition)FinalFood Safety (FSMA)
2018/08Supplemental Questions and Answers Regarding Food Facility RegistrationDraftFood Safety (FSMA)
2018/05Registration of Food Facilities: What You Need to Know About the FDA Regulation - Small Entity Compliance GuideFinalFood Safety (FSMA)
2018/05The 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 GuideFinalFood Safety (FSMA)
2018/05Menu Labeling Supplemental GuidanceFinalLabeling & Nutrition
2018/04Highly Concentrated Caffeine in Dietary SupplementsFinalDietary Supplements
2018/03Application of the Foreign Supplier Verification Program Regulation to the Importation of Live AnimalsFinalFood Safety (FSMA)
2018/03Scientific 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)FinalLabeling & Nutrition
2018/03Proper Labeling of Honey and Honey ProductsFinalLabeling & Nutrition
2018/03Reference Amounts Customarily Consumed: List of Products for Each Product CategoryFinalLabeling & Nutrition
2018/03Serving 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 GuideFinalLabeling & Nutrition
2018/01Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation - Small Entity Compliance GuideFinalFood Safety (FSMA)
2018/01Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural CommoditiesFinalFood Safety (FSMA)
2018/01Considerations 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 507DraftFood Safety (FSMA)
2018/01Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification ProgramsFinalFood Safety (FSMA)
2017/12Refusal of Inspection by a Foreign Food Establishment or Foreign GovernmentFinalFood Safety (FSMA)
2017/11Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation - Small Entity Compliance GuideFinalFood Safety (FSMA)
2017/11Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal FoodFinalFood Safety (FSMA)
2017/11Regulatory 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 ActFinalIngredients & Packaging
2017/11Use of the Terms “Brown King Crab” and “Golden King Crab” in the Labeling of Human Food ProductsFinalSeafood
2017/10Application of the “Solely Engaged” Exemptions in Parts 117 and 507DraftFood Safety (FSMA)
2024/09Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption - Small Entity Compliance GuideFinalFood Safety (FSMA)
2017/08Mitigation Strategies to Protect Food Against Intentional Adulteration - Small Entity Compliance GuideFinalFood Safety (FSMA)
2017/08Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food RuleFinalFood Safety (FSMA)
2017/08Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese ProductsFinalLabeling & Nutrition
2017/03Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs RegulationFinalFood Safety (FSMA)
2017/01Control of Listeria monocytogenes in Ready-To-Eat FoodsDraftFood Safety (FSMA)
2016/11Submitting Forms for Food Canning Establishment Registration and Food Process Filing to FDA in Electronic or Paper FormatFinalAcidified & Low-Acid Canned Foods
2016/11What You Need to Know About Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food - Small Entity Compliance GuideFinalFood Safety (FSMA)
2016/10Frequently Asked Questions about GRASFinalFood Additives
2016/10Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMADraftFood Safety (FSMA)
2016/09Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition)FinalFood Safety (FSMA)
2016/09Substantiation for Structure/Function Claims Made in Infant Formula Labels and LabelingDraftInfant Formula
2016/09Use of the Term “Healthy” in the Labeling of Human Food ProductsFinalLabeling & Nutrition
2016/08Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and FacilitiesDraftFood Safety (FSMA)
2016/08Calorie Labeling of Articles of Food in Vending MachinesDraftLabeling & Nutrition
2016/08Calorie Labeling of Articles of Food in Vending Machines - Small Entity Compliance GuideFinalLabeling & Nutrition
2016/07FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition LabelsFinalLabeling & Nutrition
2016/05Ingredients Declared as Evaporated Cane JuiceFinalLabeling & Nutrition
2016/05Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part IIFinalLabeling & Nutrition
2016/04Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and ReportsFinalInfant Formula
2016/03Acrylamide in FoodsFinalChemical Contaminants
2016/02Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Nutrient Content Claims - Small Entity Compliance GuideFinalLabeling & Nutrition
2015/11Questions and Answers on FDA’s Fortification PolicyFinalLabeling & Nutrition
2015/09Colored Sea SaltFinalColor Additives
2015/07Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and TransportationFinalEggs
2015/06Food Allergen Labeling Exemption Petitions and NotificationsFinalAllergens
2015/03Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments - Small Entity Compliance GuideFinalLabeling & Nutrition
2014/06Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for "Eligible" Infant FormulasFinalInfant Formula
2014/06Assessing 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 AdditivesFinalIngredients & Packaging
2014/06Gluten-Free Labeling of Foods - Small Entity Compliance GuideFinalLabeling & Nutrition
2014/04What You Need to Know About Establishment and Maintenance of Records - Small Entity Compliance GuideFinalFood Defense
2014/04FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic ActFinalFood Defense
2014/01Dear Manufacturer Letter Regarding Changes to FDA’s Administration of Process Filings (Forms FDA 2541a and FDA 2541c) for Acidified Foods and Low-Acid Canned FoodsFinalAcidified & Low-Acid Canned Foods
2014/01Distinguishing Liquid Dietary Supplements from BeveragesFinalDietary Supplements
2014/01Considerations Regarding Substances Added to Foods, Including Beverages and Dietary SupplementsFinalIngredients & Packaging
2013/09Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection ActFinalDietary Supplements
2013/03What You Need to Know About Administrative Detention of Foods - Small Entity Compliance GuideFinalFood Defense
2013/01Food Labeling GuideFinalLabeling & Nutrition
2012/05Establishing an Allowable Level for di (2-ethylhexyl)phthalate in Bottled Water - Small Entity Compliance GuideFinalBottled Water & Carbonated Soft Drinks
2012/03Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal FoodsFinalSalmonella
2012/02Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)FinalFood Defense
2011/12Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and TransportationFinalEggs
2011/11Letter to Firms that Grow, Harvest, Sort, Pack, Process, or Ship Fresh CantaloupeFinalProduce & Plant Products
2011/10Evaluating the Safety of Flood-affected Food Crops for Human ConsumptionFinalProduce & Plant Products
2011/10Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization ActFinalFood Safety (FSMA)
2011/09Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an IngredientFinalSalmonella
2011/08What You Need to Know About Prior Notice of Imported Food ShipmentsFinalFood Defense
2011/04Questions and Answers About the Food Additive or Color Additive Petition ProcessFinalFood Additives
2011/03Letter to Firms that Grow, Harvest, Sort, Pack, or Ship Fresh CilantroFinalProduce & Plant Products
2010/12Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements - Small Entity Compliance GuideFinalDietary Supplements
2010/11Safety 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 CeramicwareFinalImports & Exports
2010/10Food Additive Petition Expedited ReviewFinalFood Additives
2010/07Enzyme Preparations: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS NoticesFinalFood Additives
2010/07Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal FeedFinalNatural Toxins
2010/06FDA Letter to Industry Concerning Liquid Vitamin D Dietary SupplementsFinalDietary Supplements
2010/05Use of Water by Food Manufacturers in Areas Subject to a Boil-Water AdvisoryFinalEmergency Response
2010/05Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)DraftReportable Food Registry
2010/04Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage - Small Entity Compliance GuideFinalSalmonella
2010/04Sanitary Transportation of FoodFinalSanitation & Transportation
2010/03Bottled Water and Total Coliform and E. coli - Small Entity Compliance GuideFinalBottled Water & Carbonated Soft Drinks
2010/03Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive SafetyDraftIngredients & Packaging
2010/03Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007FinalReportable Food Registry
2009/10Letter Regarding Point of Purchase Food LabelingFinalLabeling & Nutrition
2009/09Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection ActFinalDietary Supplements
2009/09Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007FinalReportable Food Registry
2009/07Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical DevicesFinalColor Additives
2009/06Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection ActFinalDietary Supplements
2009/06Bottled Water and Residual Disinfectants and Disinfection Byproducts - Small Entity Compliance GuideFinalMetals
2009/05CPG Sec 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 - Compliance Policy GuideFinalFood Defense
2009/05Health Claims on Calcium and Osteoporosis; and Calcium, Vitamin D, and Osteoporosis - Small Entity Compliance GuideFinalLabeling & Nutrition
2009/04Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain These Color Additives - Small Entity Compliance GuideFinalColor Additives
2009/04Bottled Water and Arsenic - Small Entity Compliance GuideFinalMetals
2009/04Bottled Water and Uranium - Small Entity Compliance GuideFinalMetals
2009/03Recommendations for Submission of Chemical and Technological Data for Direct Food Additive PetitionsFinalFood Additives
2009/03Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an IngredientFinalProduce & Plant Products
2009/02Referral 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 AssociationFinalSeafood
2009/021991 Letter to Seafood Manufacturers Regarding the Fraudulent Practice of Including Glaze (ice) as Part of the Weight of Frozen SeafoodFinalSeafood
2009/01Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic ActFinalDietary Supplements
2009/01Evidence-Based Review System for the Scientific Evaluation of Health ClaimsFinalLabeling & Nutrition
2008/12Dear Manufacturer Letter Regarding Front-of-Package SymbolsFinalLabeling & Nutrition
2008/07Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk - Small Entity Compliance GuideFinalDietary Supplements
2008/07Standard of Identity for White Chocolate - Small Entity Compliance GuideFinalFood Standards
2008/07Nutrient 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 GuideFinalLabeling & Nutrition
2008/04Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part IFinalLabeling & Nutrition
2008/02Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and VegetablesFinalProduce & Plant Products
2007/12Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances (Chemistry Recommendations)FinalFood Additives
2007/10Food Security Preventive Measures Guidance for Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk ProcessorsFinalFood Defense
2007/10Food Security Preventive Measures Guidance for Retail Food Stores and Food Service EstablishmentsFinalFood Defense
2007/09Dear Manufacturer Letter Regarding Sugar Free ClaimsFinalLabeling & Nutrition
2007/07Redbook 2000: Toxicological Principles for the Safety Assessment of Food IngredientsFinalFood Additives
2007/06Refrigerated Carrot Juice and Other Refrigerated Low-Acid JuicesFinalJuice
2007/05Small Business Nutrition Labeling ExemptionFinalLabeling & Nutrition
2007/02Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT TrainingFinalFood Defense
2007/01Dear Manufacturer Letter Regarding Food LabelingFinalLabeling & Nutrition
2006/11Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement PolicyFinalChemical Contaminants
2006/08Estimating Dietary Intake of Substances in FoodFinalFood Additives
2006/06Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food UseFinalBiotechnology
2006/06Summary Table of Recommended Toxicological Testing for Additives Used in FoodFinalFood Additives
2006/05Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSANFinalFood Additives
2006/05FDA's Implementation of Qualified Health ClaimsFinalLabeling & Nutrition
2006/03Frequently Asked Questions about FDA's Regulation of Infant FormulaFinalInfant Formula
2006/02Whole Grain Label StatementsDraftLabeling & Nutrition
2005/11Notice to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport VehiclesFinalFood Defense
2005/11Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002FinalFood Defense
2005/09Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and CiderFinalJuice
2005/05Channels 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 ConsiderationsFinalPesticides
2005/04Dietary Supplement Labeling GuideFinalDietary Supplements
2005/04Pre-Petition Consultations for Food Additives and Color AdditivesFinalFood Additives
2005/04Templates for Reporting Toxicology DataFinalFood Additives
2005/04Submitting Requests under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food-Contact ArticlesFinalFood Additives
2004/10Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction PurposesFinalJuice
2004/03Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First EditionFinalJuice
2003/10Label Warning Statements for Iron-Containing Supplements and Drugs - Small Entity Compliance GuideFinalDietary Supplements
2003/09Questions and Answers on Juice HACCP Regulation (2003)FinalJuice
2003/08Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims - Small Entity Compliance GuideFinalLabeling & Nutrition
2003/07Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary SupplementsFinalLabeling & Nutrition
2003/06Standardized Training Curriculum for Application of HACCP Principles to Juice ProcessingFinalJuice
2003/04Bulk Transport of Juice Concentrates and Certain Shelf-Stable JuicesFinalJuice
2003/04Juice HACCP - Small Entity Compliance GuideFinalJuice
2002/12Implementation 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"FinalSeafood
2002/11Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been ReconditionedDraftImports & Exports
2002/10Exemptions from the Warning Label Requirement for JuiceFinalJuice
2002/10Implementation 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 IrradiationFinalLabeling & Nutrition
2002/10Guidance for Small Businesses: Submission of Comments for CFSAN RulemakingFinalSmall Business
2002/06Channels of Trade Policy for Commodities with Vinclozolin ResiduesFinalPesticides
2002/01Structure/Function Claims - Small Entity Compliance GuideFinalDietary Supplements
2001/11Fumonisin Levels in Human Foods and Animal FeedsFinalNatural Toxins
2001/09Questions and Answers on Juice HACCP RegulationFinalJuice
2001/07Safe Handling Statements on Labeling of Shell Eggs and the Refrigeration of Shell Eggs Held for Retail Distribution - Small Entity Compliance GuideFinalEggs
2001/07Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin - Small Entity Compliance GuideFinalLabeling & Nutrition
2001/07Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery ProductsFinalSeafood
2000/12Channels of Trade Policy for Commodities with Methyl Parathion ResiduesFinalPesticides
2000/08Action Levels for Poisonous or Deleterious Substances in Human Food and Animal FeedFinalContaminates
1999/12Seafood HACCP Transition GuidanceFinalSeafood
1999/07Antimicrobial Food AdditivesFinalFood Additives
1999/01Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements - Small Entity Compliance GuideFinalDietary Supplements
1999/01Questions and Answers on HACCP Regulation for Fish and Fishery ProductsFinalSeafood
1998/10Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and VegetablesFinalProduce & Plant Products
1998/06Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific BodyFinalLabeling & Nutrition
1998/05Food Defect Levels HandbookFinalSanitation & Transportation
1998/03Guide for Developing and Using Data Bases for Nutrition LabelingFinalLabeling & Nutrition
1997/10Consultation Procedures under FDA's 1992 Statement of Policy for Foods Derived from New Plant VarietiesFinalBiotechnology
1997/02Labeling of Foods that Need Refrigeration by ConsumersFinalLabeling & Nutrition
1996/06Label Declaration of Allergenic Substances in Foods; Notice to ManufacturersFinalLabeling & Nutrition
1995/06Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy WrappersFinalLead
1993/10Guidelines for Determining Metric Equivalents of Household MeasuresFinalLabeling & Nutrition

 



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