|
2024/12
|
Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula |
Draft |
Infant Formula |
| 2024/11 |
FDA's Voluntary Qualified Importer Program
|
Final |
Imports & Exports |
| 2024/08 |
Voluntary Sodium Reduction Goals (Edition 2)
|
Draft |
Ingredients & Packaging |
| 2024/04 |
Revocation of Uses of Partially Hydrogenated Oils in Foods - Small Entity Compliance Guide
|
Final |
Ingredients & Packaging |
| 2024/04 |
New Dietary Ingredient Notification Master Files for Dietary Supplements
|
Draft |
Dietary Supplements |
| 2024/04 |
New Dietary Ingredient Notifications and Related Issues (Revised Draft)
|
Draft |
Dietary Supplements |
| 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)
|
| 2022/02 |
Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards |
Final |
Food Safety (FSMA) |
| 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 |
Ingredients & Packaging |
| 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 |
| 2020/08 |
Action Level for Inorganic Arsenic in Rice Cereals for Infants |
Final |
Metals |
| 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) |
| 2024/09 |
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) |
| 2016/11 |
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 |
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 |
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 |
| 2013/09 |
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 |
| 2011/04 |
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 |
| 2010/07 |
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 |
| 2009/06 |
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 |
| 2007/12 |
Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances (Chemistry Recommendations) |
Final |
Food Additives |
| 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 |
| 2006/03 |
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 |
| 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 |
| 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 |
Seafood HACCP Transition Guidance |
Final |
Seafood |
| 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 |
| 1998/06 |
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 |
| 1997/02 |
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 |
