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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2014 2013 2012 2011 2010 2009 2008

2007 2006 2005 2004 2003 2002 2001

2000 1999 1998 1997 1996 1995 1993

Cosmetics Guidance Documents

Manual of Compliance Policy Guides - Chapter 5 Food, Colors, and Cosmetics

Federal Register and the Code of Federal Regulations for Food and Dietary Supplements

Foods Program Guidance Under Development

Search all FDA Guidance Documents

2020

Guidance Issued During COVID-19 Public Health Emergency
- Sanitation & Transportation: Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic (May 2020) - Updated
  See Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remain (September 2023)
- Eggs: Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency (April 2020) - No longer in effect
- Food Safety: Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency (May 2020) - No longer in effect
- Food Safety (FSMA): 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from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (May 2020) - No longer in effect
- Labeling & Nutrition: Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines (May 2020) - No longer in effect
- Labeling & Nutrition: Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency (April 2020) - No longer in effect
- Labeling & Nutrition: Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency (April 2020) - No longer in effect
- Labeling & Nutrition: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency (March 2020) - No longer in effect
Food Defense (Prior Notice): Prior Notice of Imported Food Contingency Plan for System Outages (November 2020)
Food Defense: (DRAFT) Supplemental Mitigation Strategies to Protect Food Against Intentional Adulteration (February 2020)
Food Safety (FSMA): U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration (October 2020)
Labeling & Nutrition: The Use of an Alternate Name for Potassium Chloride in Food Labeling (December 2020)
Labeling & Nutrition: (DRAFT) Voluntary Disclosure of Sesame as an Allergen (November 2020)
Labeling & Nutrition: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels (October 2020)
Labeling & Nutrition: Revision of the Nutrition and Supplement Facts Labels; Small Entity Compliance Guide (January 2020)
Metals: Action Level for Inorganic Arsenic in Rice Cereals for Infants (August 2020)

2019

Food Defense: (DRAFT) Mitigation Strategies to Protect Food Against Intentional Adulteration (March 2019)
Food Safety (FSMA): Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 (June 2019)
Food Safety (FSMA): (DRAFT) Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (June 2019)
Food Safety (FSMA): Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds (March 2019)
Infant Formula: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk (May 2019)
Labeling & Nutrition: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics (December 2019)
Labeling & Nutrition: Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals (Revised December 2019)
Labeling & Nutrition: Policy Related to Cranberry Products with Added Flavorings (August 2019)
Labeling & Nutrition: Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels (August 2019)
Labeling & Nutrition: Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products (June 2019)
Labeling & Nutrition: (DRAFT) Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived from Genetically Engineered Atlantic Salmon (Revised March 2019)
Labeling & Nutrition: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants (Revised March 2019)

2018

Dietary Supplements: (DRAFT) Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials (September 2018)
Dietary Supplements: Highly Concentrated Caffeine in Dietary Supplements (April 2018)
Food Defense (Recalls): Questions and Answers Regarding Mandatory Food Recalls (November 2018)
Food Safety (FSMA): (DRAFT) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (October 2018)
Food Safety (FSMA): (DRAFT) Guide to Minimize Food Safety Hazards of Fresh-cut Produce (October 2018)
Food Safety (FSMA): 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 (September 2018)
Food Safety (FSMA): Questions and Answers Regarding Food Facility Registration (Seventh Edition) (August 2018)
Food Safety (FSMA): (DRAFT) Supplemental Questions and Answers Regarding Food Facility Registration (August 2018)
Food Safety (FSMA): Registration of Food Facilities: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide (May 2018)
Food Safety (FSMA): 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 (May 2018)
Food Safety (FSMA): Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals (March 2018)
Food Safety (FSMA): 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 (January 2018)
Food Safety (FSMA): Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities (January 2018)
Food Safety (FSMA): (DRAFT) 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 (January 2018)
Food Safety (FSMA): Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (January 2018)
Import & Exports: 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 (November 2018)
Imports & Exports: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile (November 2018)
Labeling & Nutrition: Menu Labeling Supplemental Guidance (May 2018)
- (DRAFT) Menu Labeling Supplemental Guidance (Edition 2) (December 2023)
Labeling & Nutrition: 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) (March 2018)
Labeling & Nutrition: Proper Labeling of Honey and Honey Products (March 2018)
Labeling & Nutrition: Reference Amounts Customarily Consumed: List of Products for Each Product Category (March 2018)
Labeling & Nutrition: 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 (March 2018)

2017

Food Safety (FSMA): (DRAFT) Refusal of Inspection by a Foreign Food Establishment or Foreign Government (December 2017)
Food Safety (FSMA): Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide (November 2017)
Food Safety (FSMA): Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food (November 2017)
Food Safety (FSMA): (DRAFT) Application of the “Solely Engaged” Exemptions in Parts 117 and 507 (October 2017)
Food Safety (FSMA): Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide (September 2017)
Food Safety (FSMA): Mitigation Strategies to Protect Food Against Intentional Adulteration - What You Need to Know About the FDA Regulation - Small Entity Compliance Guide (August 2017)
Food Safety (FSMA): Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule (August 2017)
Food Safety (FSMA): Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation (March 2017)
Food Safety (FSMA): (DRAFT) Control of Listeria monocytogenes in Ready-To-Eat Foods (January 2017)
Ingredients and Packaging: 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 (November 2017)
Labeling & Nutrition: Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products (August 2017)
Seafood: Use of the Terms “Brown King Crab” and “Golden King Crab” in the Labeling of Human Food Products (November 2017)

2016

Acidified and Low-Acid Canned Foods: 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 (November 2016)
Chemical Contaminants: Acrylamide in Foods (March 2016)
Dietary Supplements: (DRAFT) New Dietary Ingredient Notifications and Related Issues (October 2016)
Food Additives: Frequently Asked Questions about GRAS (October 2016)
Food Safety (FSMA): What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food - Small Entity Compliance Guide (November 2016)
Food Safety (FSMA): (DRAFT) Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (October 2016)
Food Safety (FSMA): Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) (September 2016)
Food Safety (FSMA): (DRAFT) Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (August 2016)
Infant Formula: (DRAFT) Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling (September 2016)
Infant Formula: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports (April 2016)
WITHDRAWN Juice: (DRAFT) Fruit Juice and Vegetable Juice as Color Additives in Food (December 2016)
Labeling & Nutrition: Use of the Term “Healthy” in the Labeling of Human Food Products (September 2016)
Labeling & Nutrition: (DRAFT) Calorie Labeling of Articles of Food in Vending Machines (August 2016)
Labeling & Nutrition: Calorie Labeling of Articles of Food in Vending Machines - Small Entity Compliance Guide (August 2016)
Labeling & Nutrition: FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels (July 2016)
Labeling & Nutrition: Ingredients Declared as Evaporated Cane Juice (May 2016)
Labeling & Nutrition: Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11) (May 2016)
Labeling & Nutrition: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids - Small Entity Compliance Guide (February 2016)

2015

Allergens: Food Allergen Labeling Exemption Petitions and Notifications (June 2015)
Color Additives: Colored Sea Salt (September 2015)
Labeling & Nutrition: Questions and Answers on FDA’s Fortification Policy (November 2015)
Labeling & Nutrition: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments - Small Entity Compliance Guide (March 2015)
Eggs: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (July 2015)

2014

WITHDRAWN Acidified and Low-Acid Canned Foods: (DRAFT) 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 (January 2014)
Acidified and Low-Acid Canned Foods: 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 (January 2014)
Dietary Supplements: Distinguishing Liquid Dietary Supplements from Beverages (January 2014)
Food Defense (Records): What You Need to Know About Establishment and Maintenance of Records (April 2014)
Food Defense (Records): FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (April 2014)
Infant Formula: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for "Eligible" Infant Formulas (June 2014 )
Ingredients and Packaging: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (January 2014)
Ingredients and Packaging: 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 (June 2014)
Labeling & Nutrition: Gluten-Free Labeling of Foods - Small Entity Compliance Guide (June 2014)

2013

Dietary Supplements: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (September 2013)
Food Defense (Administrative Detention): What You Need to Know About Administrative Detention of Foods (March 2013)
Labeling & Nutrition: Food Labeling Guide (Revised January 2013)
WITHDRAWN Seafood: Purchasing Reef Fish Species Associated with the Hazard of Ciguatera Fish Poisoning (November 2013)

2012

Bottled Water & Carbonated Soft Drinks: Bottled Water Quality Standard: Establishing an Allowable Level for di(2-ethylhexyl)phthalate (May 2012)
Food Defense (Records): Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) (February 2012)
Salmonella: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods (March 2012)

2011

Eggs: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (December 2011)
Food Additives: Questions And Answers About the Food Additive Petition Process (September 2003; Revised April 2006 and April 2011)
WITHDRAWN Food Defense (Prior Notice): Enforcement Policy Concerning Certain Prior Notice Requirements (June 2011)
Food Defense (Prior Notice): What You Need to Know About Prior Notice of Imported Food Shipments (November 2003; Revised April 2009; Revised August 2011)
Food Safety (FSMA): Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act (October 2011)
Produce & Plant Products: Letter to Firms that Grow, Harvest, Sort, Pack, Process, or Ship Fresh Cantaloupe (November 2011)
Produce & Plant Products: Evaluating the Safety of Flood-affected Food Crops for Human Consumption (October 2011)
Produce & Plant Products: Letter to Firms that Grow, Harvest, Sort, Pack, or Ship Fresh Cilantro (March 2011)
Salmonella: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient (September 2011)

2010

Bottled Water & Carbonated Soft Drinks: Bottled Water: Total Coliform and E. coli - Small Entity Compliance Guide (March 2010)
Dietary Supplements: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements -Small Entity Compliance Guide (December 2010)
Dietary Supplements: FDA Letter to Industry Concerning Liquid Vitamin D Dietary Supplements (June 2010)
Emergency Response: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory (May 2010)
Food Additives: Food Additive Petition Expedited Review (January 4, 1999; Revised October 2010)
Food Additives: Enzyme Preparations: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices (January 1993; Revised July 2010)
Imports & Exports: 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 (November 2010)
Ingredients & Packaging: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (March 2010)
WITHDRAWN Labeling & Nutrition: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010 (August 2010)
Natural Toxins: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed (June 29, 2010; Revised July 7, 2010)
Reportable Food Registry: (DRAFT) Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2) (May 2010)
Reportable Food Registry: Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007 (March 2010)
Salmonella: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage -Small Entity Compliance Guide (April 2010)
Sanitation & Transportation: Sanitary Transportation of Food (April 2010)

2009

Color Additives: 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 (April 2009)
Color Additives: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices (July 2009)
Dietary Supplements: Substantiation for Claims: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act (January 2009)
Dietary Supplements: (DRAFT) Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods (December 2009) - See Final Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages (January 2014)
Dietary Supplements: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (December 2007; Revised December 2008 and September 2009)
Dietary Supplements: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (June 2009; Revised September 2013)
Food Additives: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (March 2006; Revised March 2009)
Food Defense (Prior Notice): Compliance Policy Guide (Prior Notice) (December 2003; Revised June 2004, August 2004, November 2004, March 2005, November 2005, and May 2009)
Labeling & Nutrition: Letter Regarding Point of Purchase Food Labeling (October 2009)
Labeling & Nutrition: Evidence-Based Review System for the Scientific Evaluation of Health Claims (July 2007; Revised January 2009)
Labeling & Nutrition: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis - Small Entity Compliance Guide (May 2009)
Metals: Bottled Water: Residual Disinfectants and Disinfection Byproducts - Small Entity Compliance Guide (June 2009)
Metals: Bottled Water: Arsenic -Small Entity Compliance Guide (April 2009)
Metals: Bottled Water: Uranium - Small Entity Compliance Guide (April 2009)
Produce & Plant Products: (DRAFT) Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product As An Ingredient (June 29, 2009)
Produce & Plant Products: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient (March 2009)
WITHDRAWN Produce & Plant Products: Draft Guide to Minimize Microbial Food Safety Hazards of Leafy Greens (July 2009)
WITHDRAWN Produce & Plant Products: Draft Guide to Minimize Microbial Food Safety Hazards of Melons (July 2009)
WITHDRAWN Produce & Plant Products: Draft Guide to Minimize Microbial Food Safety Hazards of Tomatoes (July 2009)
Reportable Food Registry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (September 2009)
Seafood: 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 (January 2009; Revised February 2009)
Seafood: 1991 Letter to Seafood Manufacturers Regarding the Fraudulent Practice of Including Glaze (ice) as Part of the Weight of Frozen Seafood (February 2009)

2008

Dietary Supplements: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (July 2008)
Food Standards: Standard of Identity for White Chocolate - Small Entity Compliance Guide (July 2008)
Labeling & Nutrition: Dear Manufacturer Letter Regarding Front-of-Package Symbols (December 2008)
Labeling & Nutrition: Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part I (April 2008)
Labeling & Nutrition: Nutrient Content Claims; Definition for “High Potency” and Definition for “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods - Small Entity Compliance Guide (July 2008)
Produce & Plant Products: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (March 2007; Revised February 2008)
WITHDRAWN Seafood: 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 (January 2008)

2007

Food Additives: Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations (December 2007)
Food Additives: Toxicological Principles for the Safety Assessment of Food Ingredients: Redbook 2000 (July 2007)
Food Defense: Food and Cosmetic Security Preventive Measures Guidance
- WITHDRAWN Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance (October 2007)
- Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors Food Security Preventive Measures Guidance (October 2007)
- Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance (October 2007)
Food Defense: Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT Training (February 2007)
Juice: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices (June 2007)
Labeling & Nutrition: Dear Manufacturer Letter Regarding Food Labeling (January 2007)
Labeling & Nutrition: Small Business Nutrition Labeling Exemption ( May 2007)
Labeling & Nutrition: Dear Manufacturer Letter Regarding Sugar Free Claims (September 2007)

2006

Biotechnology: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (June 2006)
Chemical Contaminants: Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy (November 2006)
Food Additives: Summary Table of Recommended Toxicological Testing for Additives Used in Food (June 2006)
Food Additives: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition (May 2006)
Food Additives: Estimating Dietary Intake of Substances in Food (August 2006)
Infant Formula: Frequently Asked Questions about FDA's Regulation of Infant Formula (March 2006)
WITHDRAWN Labeling & Nutrition: Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act (April 2006)
Labeling & Nutrition: (DRAFT) Whole Grain Label Statements (February 2006)
Labeling & Nutrition: FDA's Implementation of "Qualified Health Claims" (May 2006)

2005

Dietary Supplements: A Dietary Supplement Labeling Guide (April 2005)
Food Additives: Pre-Petition Consultations for Food Additives and Color Additives (April 2005)
Food Additives: Templates for Reporting Toxicology Data (March 2004; Revised April 2005)
Food Additives: Submitting Requests under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food-Contact Articles (March 1996; Revised April 2005)
Food Defense: Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles (November 2005)
Food Defense (Records): Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (November 2005)
WITHDRAWN Food Defense (Prior Notice): Entry Types and Entry Identifiers - Prior Notice of Imported Food (April 2005)
Juice: Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and Cider (September 2005)
Pesticides: 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 (May 2005)

2004

Juice: Juice HACCP Hazards and Control Guidance - First Edition (Mach 2004)
Juice: Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes (October 2004)

2003

Dietary Supplements: Iron-Containing Supplements and Drugs: Label Warning Statements - Small Entity Compliance Guide (October 2003)
Juice: Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices (April 2003)
Juice: Juice HACCP - Small Entity Compliance Guide (April 4, 2003)
Juice: Standardized Training Curriculum for Application of HACCP Principles to Juice Processing (June 2003)
Juice: The Juice HACCP Regulation: Questions and Answers (September 2003)
Labeling & Nutrition: Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims - Small Entity Compliance Guide (August 2003)
Labeling & Nutrition: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (July 2003)

2002

Dietary Supplements: Structure/Function Claims - Small Entity Compliance Guide (January 2002)
Imports & Exports: (DRAFT) Regulatory Procedures Manual Chapter 9, Subchapter: Guidance Concerning Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned (November 2002)
Juice: Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively Achieving a 5-Log Pathogen Reduction (October 2002)
Labeling & Nutrition: Implementation of Section 10809 of the Farm Security and Investment Act of 2002, Pub. L. No. 107-171, § 10809 (2002) regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated with Irradiation (October 2002)
Pesticides: Channels of Trade Policy for Commodities with Vinclozolin Residues (June 2002)
Seafood: 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" (January 2002; Revised December 2002)
Small Business: Guide for Small Businesses: Submission of Comments for CFSAN Rulemaking (October 2002)

2001

WITHDRAWN Acidified and Low-Acid Canned Foods: The FDA Importer's Guide Low-Acid Canned & Acidified Foods (2001)
Eggs: Food Labeling - Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution - Small Entity Compliance Guide (July 2001)
Juice: Juice HACCP Regulation: Questions & Answers (September 2001)
Labeling & Nutrition: Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin - Small Entity Compliance Guide (July 2001)
Natural Toxins: Fumonisin Levels in Human Foods and Animal Feeds (June 6, 2000; Revised November 2001)
Seafood: Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products (July 2001)

2000

Contaminates: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed (August 2000)
Pesticides: Channels of Trade Policy for Commodities with Methyl Parathion Residues (December 2000)

1999

Dietary Supplements: Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements - Small Entity Compliance Guide (January 1999)
Food Additives: Antimicrobial Food Additives (July 1999)
WITHDRAWN Labeling & Nutrition: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999)
WITHDRAWN Produce & Plant Products: Reducing Microbial Food Safety Hazards For Sprouted Seeds (October 1999)
WITHDRAWN Produce & Plant Products: Sampling And Microbial Testing Of Spent Irrigation Water During Sprout Production (October 1999)
Seafood: Seafood HACCP Transition Policy (December 1999)
Seafood: HACCP Regulation for Fish and Fishery Products; Questions and Answers for Guidance to Facilitate the Implementation of a HACCP System in Seafood Processing (January 1999)

1998

WITHDRAWN Biotechnology: (DRAFT) Use of Antibiotic Resistance Marker Genes in Transgenic Plants (September 1998)
Labeling & Nutrition: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (June 1998)
Labeling & Nutrition: FDA Nutrition Labeling Manual -- A Guide for Developing and Using Data Bases (March 1998)
Produce & Plant Products: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (November 1997; Revised April 1998 and (October 1998)
Sanitation & Transportation: Defect Action Levels Handbook (May 1998)

1997

WITHDRAWN Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use (September 1997)
Biotechnology: Consultation Procedures - Foods Derived from New Plant Varieties (October 1997)
Labeling & Nutrition: Labeling of Foods that Need Refrigeration by Consumers (February 1997)

1996

Labeling & Nutrition: Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers (June 1996)

1995

Lead: Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy Wrappers (June 1995)

1993

Labeling & Nutrition: Guidelines for Determining Metric Equivalents of Household Measures (October 1993)

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