Food Guidance Documents

 

Recently Added 

• Food Defense: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories (October 2012)
• Food Safety (Shell Eggs): Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (August 2012)
• Acidified and Low-Acid Canned Foods: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format (July 2012)

---

 

2012  2011  2010  2009  2008  2007  2006  2005  2004  2003  2002 

2001  2000  1999  1998  1997 1996  1995  1993

 

2012 

• Acidified and Low-Acid Canned Foods: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format (July 2012)
• Food Defense: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories (October 2012)
• Food Defense: Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (February 2012)
• Food Defense: 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) 
• Food Ingredients and Packaging: Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food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 (April 2012)
• Food Safety (Shell Eggs): Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (August 2012)
• Food Safety: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods (March 2012)
• SECG: Bottled Water Quality Standard: Establishing an Allowable Level for di(2-ethylhexyl)phthalate (April 2012)

2011

• Dietary Supplements: Draft Guidance: New Dietary Ingredient Notifications and Related Issues (July 2011)
• Food Additives: Questions And Answers About the Food Additive Petition Process (September 2003; Revised April 2006 and April 2011)
• Food Defense: Enforcement Policy Concerning Certain Prior Notice Requirements (June 2011)
• Food Defense: What You Need to Know About Administrative Detention of Foods (October 2011)
• Food Safety (Shell Eggs): Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (December 2011)
• Food Safety: Evaluating the Safety of Flood-affected Food Crops for Human Consumption (October 2011) 
• Food Safety: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act (September 2011)
• Food Safety: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient (September 2011)
• Food Safety: Draft Guidance: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods (March 2011)
• Produce (Cantaloupe): Letter to Firms that Grow, Harvest, Sort, Pack, Process, or Ship Fresh Cantaloupe (November 2011)
• Produce (Cilantro): Letter to Firms that Grow, Harvest, Sort, Pack, or Ship Fresh Cilantro (March 2011)
• Seafood: Fish and Fishery Products Hazards and Controls Guidance; Fourth Edition (April 2011)

2010

• Acidified and Low-Acid Canned Foods: Draft Guidance: Acidified Foods (September 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)
• Food Ingredients and Packaging: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (March 2010)
• Food Labeling: WITHDRAWN - Draft Guidance: 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)
• Food Labeling: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws (August 2010)
• Food Safety (Pottery): The 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)
• Food Safety (Reportable Food): Draft Guidance: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2) (May 2010)
• Food Safety (Transportation): Sanitary Transportation of Food (April 2010)
• Food Safety (Reportable Food) : 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)
• Natural Toxins: Guidance for Industry and FDA: 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)
• Seafood: Guidance for Industry: The Seafood List - FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce (November 2010)
• SECG: Bottled Water: Total Coliform and E. coli; Small Entity Compliance Guide (March 2010)
• SECG: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage; Small Entity Compliance Guide (April 2010)

2009

• Chemical Contaminants: Bottled Water: Residual Disinfectants and Disinfection Byproducts Small Entity Compliance Guide (May 2009)
• Chemical Contaminants: Bottled Water: Arsenic Small Entity Compliance Guide (April 2009)
• Chemical Contaminants: Bottled Water: Uranium Small Entity Compliance Guide (April 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)
• 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)
• Food Additives: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (March 2006; Revised March 2009)
• Food Defense (Prior Notice): What You Need to Know About Prior Notice of Imported Food Shipments Small Entity Compliance Guide (November 2003; Revised April 2009)
• Food Defense (Prior Notice): Compliance Policy Guide (December 2003; Revised June 2004, August 2004, November 2004, March 2005, November 2005, and May 2009)
• Food Labeling: Ingredients Declared as Evaporated Cane Juice (October 2009)
• Food Labeling: Letter Regarding Point of Purchase Food Labeling (October 2009)
• Food Safety: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (September 2009)
• Health Claims: Evidence-Based Review System for the Scientific Evaluation of Health Claims (July 2007; Revised January 2009)
• Health Claims: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis Small Entity Compliance Guide (May 2009)
• Labeling (Beer): Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration; Draft Guidance (August 2009)
• Liquid Dietary Supplements: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods (December 2009)
• Plant Products (Nuts): Draft Guidance: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product As An Ingredient (June 29, 2009)
• Plant Products (Nuts): Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient (March 2009)
• Produce (Leafy Greens): Guide to Minimize Microbial Food Safety Hazards of Leafy Greens (July 31, 2009)
• Produce (Melons): Guide to Minimize Microbial Food Safety Hazards of Melons (July 31, 2009)
• Produce (Tomatoes): Guide to Minimize Microbial Food Safety Hazards of Tomatoes (July 31, 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: The Seafood List - FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce (September 1993; Revised January 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 (Ephedrine Alkaloids): Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (July 2008)
• Food Additives: Microbiological Considerations-Antimicrobial Food Additive Submissions (September 2007; Revised June 2008)
• Food Labeling: A Food Labeling Guide (September 1994; Revised April 2008)
• Food Labeling: Dear Manufacturer Letter Regarding Front-of-Package Symbols (December 2008)
• Food Labeling (Retail): A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods (April 2008)
• Food Processing (Ready-To-Eat): Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods (February 2008)
• Food Standards: Standard of Identity for White Chocolate; Small Entity Compliance Guide (July 17, 2008)
• Nutrient Content Claims: Food Labeling; 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 18, 2008)
• Produce: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (March 2007; Revised February 2008)
• Seafood: Draft Guidance and Protocol for Industry and Food and Drug Administration Staff: 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 (2007)
• Food Additives: Toxicological Principles for the Safety Assessment of Food Ingredients: Redbook 2000 (July 7, 2000; Revised October 2001, November 2003, April 2004, February 2006, and July 2007)
• Food And Cosmetic Security Preventive Measures Guidance
  
  • Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance (November 2003; Revised October 2007)
  • Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors Food Security Preventive Measures Guidance (November 2003; Revised October 2007)
  • Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (November 2003; Revised October 2007)
  • Importers and Filers: Food Security Preventive Measures Guidance (November 2003; Revised October 2007)
  • Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance (November 2003; Revised October 2007)
• Food Defense: Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT Training (February 2007)
• Label Claims: Dear Manufacturer Letter Regarding Food Labeling (January 2007)
• Chemical Contaminants (Lead): 1991 Letter to Bureau of Alcohol, Tobacco and Firearms Regarding Lead in Wine (March 2007)
• Food Labeling: Small Business Nutrition Labeling Exemption (October 2004; Revised May 2007)
• Juice: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices (June 2007)
• Label Claims: Dear Manufacturer Letter Regarding Sugar Free Claims (September 2007)
• Medical Foods: Frequently Asked Questions About Medical Foods (May 2007)
• Qualified Health Claims: Evidence-Based Review System for the Scientific Evaluation of Health Claims (July 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)
• Food Defense (Decontamination of Transport Vehicles): A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles (October 2005; Revised August 2006)
• Food Defense (Recordkeeping): Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4) (September 2006)
• Food Allergens: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4) (October 2006)
• Food Labeling (Soy Lecithin): 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)
• Food Labeling (Whole Grain): Draft Guidance - Whole Grain Label Statements (February 2006)
• Food Packaging: Use of Recycled Plastics in Food Packaging: Chemistry Considerations (August 2006)
• Infant Formula: Frequently Asked Questions about FDA's Regulation of Infant Formula (March 2006)
• Qualified Health Claims: FDA's Implementation of "Qualified Health Claims": Questions and Answers (May 2006)

2005

• Dairy Products: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile (May 2003; Revised June 2005)
• Dietary Supplements: A Dietary Supplement Labeling Guide (April 2005)
• Food Additives: Templates for Reporting Toxicology Data (March 2004; Revised April 2005)
• Food Defense: 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
• Food Defense (Prior Notice): Entry Types and Entry Identifiers - Prior Notice of Imported Food (April 7, 2005)
• Juice: Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and Cider (September 22, 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

• Dietary Supplements: Substantiation for Claims: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act (November 2004)
• Food Addtives Frequently Asked Questions about GRAS
• Food Defense (Prior Notice): Prior Notice of Imported Food Contingency Plan for System Outages (August 12, 2004)
• Food Defense (Prior Notice): Prior Notice of Imported Food Questions and Answers (Edition 2) (May 3, 2004)
• Food Defense (Prior Notice): Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators (August 26, 2004)
• Food Defense (Registration): Questions and Answers Regarding Registration of Food Facilities (Edition 4) (August 6, 2004)
• Food Defense (SECG): What You Need to Know About Administrative Detention of Foods (November 2004)
• Food Defense (SECG): What You Need to Know About Establishment and Maintenance of Records (December 2004)
• Juice: Juice HACCP Hazards and Control Guidance - First Edition (March 3, 2004)
• Juice: Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes (November 2004)

2003

• Dietary Supplements: Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 2003)
• Food Defense (SECG): What You Need to Know About Registration of Food Facilities (November 2003)
• Food Labeling: Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims Small Entity Compliance Guide (August 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)
• Qualified Health Claims: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (July 2003)

2002

• Dietary Supplements (Label Claims): Structure/Function Claims: Small Entity Compliance Guide (January 2002)
• Food Contact Notifications: Preparation of Food Contact Notifications: Administrative (May 2002)
• Food Contact Notifications: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations (April 2002)
• Food Labeling (Irradiation): 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 1, 2002)
• Imports: Draft Guidance: 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 5, 2002)
• Juice Labeling: Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively Achieving a 5-Log Pathogen Reduction (October 7, 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)
• Pesticides: Channels of Trade Policy for Commodities with Vinclozolin Residues (June 12, 2002)
• Small Business: Guide for Small Businesses: Submission of Comments for CFSAN Rulemaking (October 21, 2002)

2001

• Acidified and Low-Acid Canned Foods: WITHDRAWN - The FDA Importer's Guide Low-Acid Canned & Acidified Foods (2001)
• Food Labeling: Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance Guide (July 2001)
• Food Labeling (Biotechnology): Draft Guidance: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering (January 2001)
• Food Labeling (Shell 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: The Juice HACCP Regulation: Questions & Answers (August 31, 2001)
• Natural Toxins: Fumonisin Levels in Human Foods and Animal Feeds (June 6, 2000; Revised November 9, 2001)
• Seafood: Fish and Fisheries Products Hazards and Control Guide 3rd Edition (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

• 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)
• Health Claims: WITHDRAWN - Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999)
• Produce (Sprouts): Reducing Microbial Food Safety Hazards For Sprouted Seeds (October 1999)
• Seafood: Seafood HACCP Transition Policy (December 1999)

1998

• Label Claims: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (July 1998)
• Nutrition Labeling: FDA Nutrition Labeling Manual -- A Guide for Developing and Using Data Bases (March 1998)
• Produce: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (November 1997; Revised April 1998 and (October 1998)
• Sanitation: Defect Action Levels Handbook (May 1998)

1997

• Biotechnology: Consultation Procedures - Foods Derived from New Plant Varieties (October 1997)

1996

• Nutrition Labeling: Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers (June 10, 1996)

1995

• Chemical Contaminants (Lead): Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy Wrappers (June 13, 1995)

1993

• Food Labeling: Guidelines for Determining Metric Equivalents of Household Measures (October 1993)