Food Guidance Documents

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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Recently Added  

• Labeling & Nutrition: Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals (January 2017)
• Labeling & Nutrition: Draft Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category (January 2017)
• Juice: Draft Guidance for Industry: Fruit Juice and Vegetable Juice as Color Additives in Food (December 2016)
• Infant Formula: Draft Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk (December 2016)

2017  2016  2015  2014  2013  2012  2011 

2010  2009  2008  2007  2006  2005 

2004  2003  2002 2001  2000  1999 

1998  1997 1996  1995  1993

2017

• Labeling & Nutrition: Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals (January 2017)
• Labeling & Nutrition: Draft Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category (January 2017)

2016

• Food Safety (FSMA): FDA's Voluntary Qualified Importer Program (November 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• Dietary Supplements: Draft Guidance: New Dietary Ingredient Notifications and Related Issues (August 2016)
• Food Additives: Frequently Asked Questions about GRAS (October 2016)
• Food Defense (Prior Notice): Prior Notice of Imported Food Questions and Answers (Edition 3) (June 2016)
• Food Defense (Registration): Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) - Revised (December 2016)
• Food Defense (Registration): Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) (September 2016)
• Food Ingredients and Packaging: Draft Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (June 2016)
• Food Safety (FSMA): Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards (December 2016)
• Food Safety (FSMA): Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) (November 2016)
• Food Safety (FSMA): FDA's Voluntary Qualified Importer Program (November 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 (October 2016)
• Food Safety (FSMA): Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (October 2016)
• Food Safety (FSMA): Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (August 2016)
• Food Safety (FSMA): Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (August 2016)
• Food Safety (FSMA): Draft Guidance for Industry: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food) (May 2016)
• Infant Formula: Draft Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk (December 2016)
• Infant Formula: Labeling of Infant Formula (September 2016)
• Infant Formula: Draft Guidance for Industry: 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)
• Juice: Draft Guidance for Industry: Fruit Juice and Vegetable Juice as Color Additives in Food (December 2016)
• Labeling & Nutrition: Draft Guidance for Industry: 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)  (November 2016)
• Labeling & Nutrition: Use of the Term “Healthy” in the Labeling of Human Food Products (September 2016)
• Labeling & Nutrition: Draft Guidance for Industry: 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: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11) (April 2016)
• Labeling & Nutrition: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids; Small Entity Compliance Guide (February 2016)
• Medical Foods: Frequently Asked Questions About Medical Foods; Second Edition (May 2016)
• Metals: Draft Guidance for Industry: Inorganic Arsenic in Rice Cereals for Infants: Action Level (April 2016)

2015

• Allergens: Food Allergen Labeling Exemption Petitions and Notifications (June 2015)
• Color Additives: Colored Sea Salt (September 2015)
• SUPERCEDED - Food Safety (FSMA): Draft Guidance for Industry and FDA Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards (July 2015)
  See Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards (December 2016)
• SUPERCEDED - Food Safety (FSMA): Draft Guidance for Industry: FDA's Voluntary Qualified Importer Program (June 2015)
  See Draft Guidance for Industry: FDA's Voluntary Qualified Importer Program (November 2016)
• Food Defense (Recalls): Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls (May 2015)
• Labeling & Nutrition: Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon (November 2015)
• Labeling & Nutrition: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants (November 2015)
• Labeling & Nutrition: Questions and Answers on FDA’s Fortification Policy (November 2015)
• SUPERCEDED - Labeling & Nutrition: Draft Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11) (September 2015)
  See A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11) from April 2016.
• 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 Guidance for Industry: 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)
• SUPERCEDED - Allergens: Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications (May 2014)
  See Food Allergen Labeling Exemption Petitions and Notifications from May 2015.
• Dietary Supplements: Distinguishing Liquid Dietary Supplements from Beverages (January 2014)
• SUPERCEDED - Food Defense (Prior Notice): Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3) (March 2014)
  See Prior Notice of Imported Food Questions and Answers (Edition 3) from June 2016
• 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)
•  DRAFT UPDATE ISSUED - Food Defense (Registration): Questions and Answers Regarding Food Facility Registration (Sixth Edition) (November 2014)
  See Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) - Revised from December 2016 
• 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: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration (December 2014)
• Labeling & Nutrition: Gluten-Free Labeling of Foods; Small Entity Compliance Guide (June 2014)
• Labeling & Nutrition: Draft Guidance for Industry: Proper Labeling of Honey and Honey Products; Draft Guidance (April 2014)
• Infant Formula: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for "Eligible" Infant Formulas (June 2014 )
• SUPERCEDED - Infant Formula: Draft Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for “Eligible” Infant Formulas February 2014
  See  Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for "Eligible" Infant Formulas  from June 2014 .
  
• SUPERCEDED - Infant Formula: Draft Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports February 2014
  See Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports from April 2016

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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)
• Eggs: Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access) (July 2013)
• Food Defense (Administrative Detention): What You Need to Know About Administrative Detention of Foods (March 2013)
• Imports & Exports: Establishing and Maintaining a List of U.S. Milk Product Manufacturers/Processors with Interest in Exporting to China  (January 2014)
• SUPERCEDED - Medical Foods: Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition (August 2013)
  See Frequently Asked Questions About Medical Foods; Second Edition May 2016
• Metals: Draft Guidance for Industry: Arsenic in Apple Juice - Action Level (July 2013)
• Seafood: Purchasing Reef Fish Species Associated with the Hazard of Ciguatera Fish Poisoning (November 2013)

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2012

• SUPERCEDED - 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)
  See Guidance for Industry: 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 from October 2015
• Food Defense (Registration): What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide (December 2012)
• SUPERCEDED - Food Defense (Registration): Questions and Answers Regarding Food Facility Registration (Fifth Edition) (December 2012)
  See Questions and Answers Regarding Food Facility Registration (Sixth Edition) from November 2014
• SUPERCEDED - Food Defense (Registration):Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (October 2012)
  See Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) from September 2016.
• SUPERCEDED - Food Defense (Records): Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (February 2012)
  See FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act  from April 2014.
• 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) 
• SUPERCEDED - 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)
  See 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 from June 2014.
• Salmonella: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods (March 2012)
• Seafood: The Seafood List - FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce (September 1993; January 2009; Revised July 2012)
• Bottled Water & Carbonated Soft Drinks: Bottled Water Quality Standard: Establishing an Allowable Level for di(2-ethylhexyl)phthalate (April 2012)

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2011

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

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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)
• Ingredients and Packaging: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (March 2010)
• Labeling & Nutrition: WITHDRAWN - Guidance for Industry: 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)
• Imports & Exports: 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)
• Reportable Food Registry: Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2) (May 2010)
• Sanitation & Transportation: Sanitary Transportation of Food (April 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)
• 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)
• Bottled Water & Carbonated Soft Drinks: Bottled Water: Total Coliform and E. coli; Small Entity Compliance Guide (March 2010)
• Salmonella: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage; Small Entity Compliance Guide (April 2010)

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2009

• Metals: Bottled Water: Residual Disinfectants and Disinfection Byproducts Small Entity Compliance Guide (May 2009)
• Metals: Bottled Water: Arsenic Small Entity Compliance Guide (April 2009)
• Metals: 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; 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 (December 2003; Revised June 2004, August 2004, November 2004, March 2005, November 2005, and May 2009)
• SUPERCEDED - Food Labeling: Draft Guidance for Industry: Ingredients Declared as Evaporated Cane Juice (October 2009)
  See Ingredients Declared as Evaporated Cane Juice from May 2016.
• Labeling & Nutrition: Letter Regarding Point of Purchase Food Labeling (October 2009)
• SUPERCEDED - Labeling & Nutrition: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration; Draft Guidance (August 2009)
  See Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration from December 2014.
• 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)
• 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)
• Dietary Supplements: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods (December 2009)
• Produce & Plant Products: Draft Guidance for Industry: 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)
• Produce & Plant Products: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens (July 31, 2009)
• Produce & Plant Products: Guide to Minimize Microbial Food Safety Hazards of Melons (July 31, 2009)
• Produce & Plant Products: 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: 1991 Letter to Seafood Manufacturers Regarding the Fraudulent Practice of Including Glaze (ice) as Part of the Weight of Frozen Seafood (February 2009)

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2008

• Dietary Supplements: 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)
• Labeling & Nutrition: A Food Labeling Guide (September 1994; Revised April 2008)
• Labeling & Nutrition: Dear Manufacturer Letter Regarding Front-of-Package Symbols (December 2008)
• Labeling & Nutrition: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part I (April 2008)
• Retail Food Protection: 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)
• Labeling & Nutrition: 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 & 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: Certification of Fish and Fishery Products for Export to the European Union and European Free Trade Association (January 2008)

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2007

• Food Additives: Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations
• Food Additives: Toxicological Principles for the Safety Assessment of Food Ingredients: Redbook 2000 (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 (October 2007)
  • Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (October 2007)
  • Importers and Filers: 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)
• Labeling & Nutrition: 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)
• Labeling & Nutrition: Small Business Nutrition Labeling Exemption ( May 2007)
• Juice: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices (June 2007)
• Labeling & Nutrition: Dear Manufacturer Letter Regarding Sugar Free Claims (September 2007)

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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: 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(August 2006)
• Food Allergens: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4) (October 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 Guidance - Whole Grain Label Statements (February 2006)
• 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)
• Labeling & Nutrition: FDA's Implementation of "Qualified Health Claims": Questions and Answers (May 2006)

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2005

• Imports & Exports: 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: 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 (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)
• 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)

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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)
• SUPERCEDED - Food Additives: Frequently Asked Questions about GRAS (December 2004)
  See Frequently Asked Questions about GRAS from October 2016
• Food Defense (Prior Notice): Prior Notice of Imported Food Contingency Plan for System Outages (August  2004)
• SUPERCEDED - Food Defense (Prior Notice): Prior Notice of Imported Food Questions and Answers (Edition 2) (May 2004)
  See Prior Notice of Imported Food Questions and Answers (Edition 3) from March 2014
• Food Defense (Prior Notice): Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators (August 2004)
• SUPERCEDED - Food Defense (Records): What You Need to Know About Establishment and Maintenance of Records (December 2004)
  See What You Need to Know About Establishment and Maintenance of Records from April 2014
• 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 (November 2004)

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2003

• Dietary Supplements: Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 2003)
• Labeling & Nutrition: 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)
• Labeling & Nutrition: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (July 2003)

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2002

• Dietary Supplements: Structure/Function Claims: Small Entity Compliance Guide (January 2002)
• Ingredients & Packaging: Preparation of Food Contact Notifications: Administrative (May 2002)
• Ingredients & Packaging: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations (April 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)
• Imports & Exports: 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 2002)
• Juice: Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively Achieving a 5-Log Pathogen Reduction (October 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 2002)
• Small Business: Guide for Small Businesses: Submission of Comments for CFSAN Rulemaking (October 2002)

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2001

• Acidified and Low-Acid Canned Foods: WITHDRAWN - The FDA Importer's Guide Low-Acid Canned & Acidified Foods (2001)
• Labeling & Nutrition: Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance Guide (July 2001)
• SUPERCEDED - Labeling & Nutrition: Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering (January 2001)
  See Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants (November 2015)
• 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: Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products (July 2001)

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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)

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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)
• Produce & Plant Products: Reducing Microbial Food Safety Hazards For Sprouted Seeds (October 1999)
• 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)

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1998

• WITHDRAWN - Biotechnology: Draft Guidance for Industry: 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 (July 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)

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1997

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

1996

• Labeling & Nutrition: 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

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

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