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Table of Contents |
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Government regulations may often be complex and difficult to follow, and the Food and Drug Administration's are no exception. The purpose of FDA's regulations is to insure that foods and cosmetics are safe, pure and properly labeled. If the regulations are not followed, FDA may take legal action. But FDA's regulatory philosophy also includes prevention through assistance as a complement to legal action.
To make this philosophy a reality, FDA's Center for Food Safety and Applied Nutrition (CFSAN) has developed an industry assistance program. CFSAN's Industry Activities Staff is responsible for providing assistance to industry, mainly in the form of information materials.
This catalog--the Information Materials for the Food and Cosmetic Industries--lists available materials. It describes publications of interest to all facets of these industries. Most of these publications can be accessed by using the indicated web site links.
You will note that these materials are available from non-government sources as well as FDA and other agencies. Non-government materials have been included, not as an endorsement of them, but because they contribute toward the mutual FDA/industry goal of safe and quality products.
Please take some time to read this catalog and order any materials of interest to you. Be sure to bookmark this catalog for future reference. In addition to information materials, it lists addresses and telephone numbers for FDA and other government agencies.
For further information and assistance, please contact any FDA District Office or the Industry Activities Staff.
Information materials are grouped by subject. Within each subject area there is a list of publications. Subjects are arranged in the catalog alphabetically.
The Industry Activities Staff (IAS) is the source for many of the information materials in this catalog. However, other FDA offices as well as some private associations have developed excellent materials which we feel are important to include. Please follow carefully the ordering instructions below. Requesting materials from the correct source will help minimize delays in processing your order.
General Publications | |
| Classification of Visible Flexible Defects Packages (1989) | Poster. Will help food industry personnel learn to
identify flexible
package defects and classify them as minor, major, or critical. Source: AOAC International |
| Compliance References | Links to documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel. |
| Food and Cosmetics Compliance Programs | Manual. Contains inspectional and analytical directives implemented by FDA Field Units. Provides direction for general enforcement of laws and regulations. |
| FDA's Food and Cosmetic Regulatory Responsibilities (1995) | A summary of the legal requirements affecting the manufacture and distribution of food and cosmetic products within and imported into the United States. |
| FDA Recall Policies (2002)
Guidance Document |
Explains the three classes of recalls and discusses FDA's role in the recall process. |
| FDLI's Compilation of Food and Drug Laws (1996) | Book. A collection of major laws affecting the food and drug industry.
Volume I - Covers all the basics, from the original Food and Drugs
Act of 1906 to the Administrative Procedure Act and Federal Fines and
Sentencing Guidelines. Source: The Food and Drug Law Institute |
| Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking | |
| Investigations Operations Manual (2008) | Manual. Provides standard operation procedures for FDA
Investigators. The inspectional
methods cover sanitation, micro problems, labeling, standards, and GMP's.
Order No. PB-95-913399 |
| Official Methods of Analysis of the AOAC International 17th Edition 2002 | This edition contains over 2800 collaboratively tested chemical and
biological methods.
Source: AOAC International Publications: Official Methods of Analysis of AOAC INTERNATIONAL, 17th Edition current through 1st Revision, 2002 |
| Procedure for Obtaining Certificates for Export of Foods and Cosmetics (2000) | Question and answer guide for manufacturers engaged in exporting FDA regulated food and cosmetic products to a foreign country. |
| Regulatory Procedures Manual (2008) | Contains directives for recalls, legal actions, and cooperative
agreements with states, such as those under the Public Health Service.
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| The Food Chemical News Guide | Listing of all food and color additives and GRAS items. Current updates
on a continuing basis. Purchase from:
Food Chemical News |
| Search Programs that provide access to: Federal Register Documents, Code of Federal Regulations, Food, Drug, and Cosmetic Act |
The Government Printing Office maintains search programs
that provide access to these documents. These documents are also available
in a printed version. Source: Government Printing Office |
| FDA's
Development, Issuance, and Use
of Guidance Documents
Guidance Document |
Announces FDA's publication of "Good Guidance Practices". |
| 21 CFR Part 11 Electronic Records; Electronic Signatures | Provides criteria for acceptance by FDA under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. |
| Other FDA Web Pages on: | |
Chemical and Pesticide ContaminantsPublications | |
| Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed (2000) | Lists allowable action levels for contaminants in food and feed. |
| Journal of AOAC International, Official Methods of Analysis of AOAC International | Source: AOAC International |
| History of FDA's Total Diet Study | |
| FDA Total Diet Study | |
| FDA's Total Diet Study: Monitoring U.S. Food Supply Safety | Reprint: Food Safety Magazine June/July 2002 issue. |
| FDA Total Diet Study, Summary of Residues Found Ordered by Pesticide, September 2000 (available in PDF) | Document displays summary values for each pesticide or other organic residue found in FDA's Total Diet Study, Market Baskets 1991-3 through 2003-4 |
| FDA Pesticide Program: Residue Monitoring - Annual Reports (1993-2003) | Summary of the results of the Food and Drug Administration's (FDA) pesticide residue monitoring of domestic and imported food. |
| Pesticides Analytical Manual (1999) | Contains the procedures and methods used in FDA labs for
regulatory examination of food and feed samples to determine
compliance with the FD&C Act. Volume 1 - Order No.PB94-911899 |
| Other FDA Web Pages on Chemical and Pesticide Contamination | |
CosmeticPublications | |
| 2008 International Cosmetic Ingredient (INCI) Dictionary & Handbook, 12th Edition (2008) | Provides a listing of ingredients used in cosmetics and other personal care products, with common nomenclature for use in preparing ingredient labels; cross-references INCI names with trade names, technical names, and suppliers. |
|
Labeling Manual: A Guide to Cosmetic and OTC Drug Labeling and Advertising, 8th Edition |
An illustrated manual for labeling cosmetic and OTC drug products in compliance with the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. |
|
2008 CIR Compendium |
Contains information on more than 1,320 safety assessments of individual cosmetic ingredients. |
| Safety Evaluation Guidelines | Provides approaches for substantiating the safety of cosmetic products and ingredients. Includes brief descriptions of a number of standard toxicology test procedures. |
| Microbiology Guidelines | Provides approaches for establishing and maintaining a microbiological quality program for cosmetic manufacturers, contract packagers, and raw material suppliers. |
| Quality Assurance Guidelines | Provides approaches for cosmetic manufacturers to establish and maintain a quality assurance program. |
| International Regulatory Resource Manual, 6th Edition | Lists cosmetic regulations and requirements for 74 countries. Contains sections on legal authority; registration, licensing, notification requirements, ingredient restrictions, packaging and labeling requirements, and microbiological limits. Personal Care Products Council publications are available for purchase from: Personal Care Products Council (202) 331-1969 (fax) Source: The Personal Care Products Council Publications Store |
| Newburger's Manual of Cosmetic Analysis Second Edition | Revised to reflect current methodology. Includes standard
methods of analysis, covering the important areas of cosmetic
microbiology, colors, perfumes, fragrances, preservatives, nail
cosmetics, lipsticks, shampoos, antiperspirants, cold
waves, hair dyes, sunscreens, depilatories, and toothpastes. Source: AOAC International |
| FDA-ICMAD Simplified Guide to Cosmetic Labeling | A simplified guide to assist cosmetic companies in labeling their products in compliance with the referenced statutory and regulatory requirements. Purchase from: Independent Cosmetic |
| Other FDA Web Pages on Cosmetics | |
Dietary SupplementsPublications | |
| A Dietary Supplement Labeling
Guide April 2005
Guidance Document |
|
| Industry Information and Regulations | |
| Labeling of Dietary Supplements | |
| Statement of Identity,
Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance
Guide (January 1999)
Guidance Document |
|
| Other FDA Web Pages on Dietary Supplements | |
Food AdditivesPublications | |
|
Office of
Food Additive Safety | |
| Enzyme Preparations: Chemistry Recommendations For Food
Additive and GRAS Affirmation Petitions (January 1993)
Guidance Document |
Describes requirements for chemistry data needed to support food additive and GRAS petitions for the preparation of enzymes used in processing food. |
| Food Additive Petitions: Information and Guidance | Booklet. This booklet includes copies of the regulations and agency guidelines pertaining to the preparation of food and color additives and GRAS affirmation petitions. |
| Submitting Requests
Under 21 CFR 170.39
Threshold of Regulation For Substances Used in Food-Contact Articles (2005)
Guidance Document |
Lists the information that should be submitted to FDA when requesting that the agency review a specific use of a food contact article to determine whether its components will require regulation as a food additive. |
| Management Programs, Policies and Procedures | This booklet discusses the policies, authority and procedures for FDA review of food and color additive petitions and GRAS affirmation petitions. |
| Use of Recycled Plastics in Food Packaging: Chemistry
Considerations (August 2006) Guidance Document |
This document provides assistance to manufacturers of food packaging in evaluating processes for producing packaging from post-consumer recycled plastic. |
| Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations (December 2007) | Data necessary for supporting petitions for materials that may be in contact with foods; e.g.,packaging materials. |
| Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (March 2006)
Guidance Document |
Describes the types of chemistry data necessary for supporting petitions for regulations of direct food additives such as synthetic sweeteners, and preservatives; or the affirmation of the use of food ingredients as generally recognized as safe (GRAS) such as sucrose, and many enzymes used in food processing. |
| Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions | These guidelines provide explanation of the requirements for, and guidance in the submission of petitions for regulation of sanitizing solutions used in the food processing industry and to sanitize utensils, china, and glassware in food service operations. |
| Statement of Policy: Foods Derived from New Plant Varieties: Notice | Leaflet. Frequently asked questions and their answers to FEDERAL REGISTER notice dated May 29, 1992; 57 FR 22984. |
| Other FDA Web Pages on Food Additives | |
Food AllergensPublications | |
|
Questions and Answers Regarding Food Allergens, including th
Allergen Labeling and Consumer Protection Act of 2004 (Edition 4)
Guidance document |
|
| Other FDA Web Pages on Food Allergens | |
Food LabelingPublications | |
|
A Food Labeling Guide (April 2008)
Guidance Document |
This booklet is a summary of the required statements that must appear on food labels. |
| A Labeling Guide for Restaurants and Ot
Retail Establishments Selling Away-From-Home Foods (April 2008)
Guidance Document |
|
| Label Claims | |
| Methods of Analysis for Nutrition Labeling | Book. Developed to assist in compliance with the provisions of the
Nutrition Labeling and Education Act (NLEA) of 1990. It provides the
user with information of how to test food products. Over 200 AOAC
Official Methods pertinent to nutrition labeling are arranged
alphabetically by nutrient. Source: AOAC International |
| Small Business Nutrition Labeling
Exemption (October 1, 2004; Updated May 7, 2007)
Guidance Document |
Introduction, Model Form and Instructions |
| Fair Packaging and Labeling Act Manual (June 1978)
Guidance Document |
Book. Presents FDA's interpretations of the requirements of the
Fair Packaging and Labeling Act as it applies to foods, drugs, cosmetics,
and medical devices. Order No. PB-83-222117 |
|
FDA Nutrition Labeling Manual -- A Guide
for Developing and Using Data Bases (March 1998)
Guidance Document |
Generic instructions for developing and preparing an acceptable data base when valid estimates of nutrient content and variation are not available for the food (single or mixed products) to be labeled. |
| Guidelines for Determining Metric Equivalents of Household Measures (October 1, 1993) | Office of Nutrition, Labeling and Dietary Supplements |
|
Exemptions from the Warning Label Requirement
for Juice - Recommendations for Effectively Achieving a 5-Log Pathogen
Reduction
(October 2002)
Guidance Document |
Office of Plant and Dairy Foods and Beverages |
|
Food Labeling:
Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of
Shell Eggs Held for Retail Distribution; Small Entity Compliance
Guide (July 2001)
Guidance Document |
U. S. Food and Drug Administration |
| Other FDA Web Pages on Food Labeling | |
Food ProcessingPublications |
|
| Current Good Manufacturing Practice (GMP) | Booklet. Includes provisions for personnel, plants and grounds,
sanitary operations, and production and process controls. A reprint of
21 CFR 110
Source: Industry Activities Staff |
| Classification of Visible Can Defects | Poster--24" x 36". A combination of photographs,
easy-to-follow explanations, and color codings to illustrate can
defects, classify them according to degree of potential hazards, and
show what to look for in routine inspection of the finished product.
Source: AOAC International
|
| Bacteriological Analytical Manual 7th Edition (1992)
(hard copy edition)
Guidance Document |
Manual. Provides quantitative and qualitative bacteriological testing procedures for detecting microbiological contamination. Contains screening procedures for Salmonella, Shigella, Clostridium botulinum, etc. Source: AOAC International |
| Bacteriological
Analytical Manual Online (2001)
Guidance Document |
|
| Other FDA Web Pages on | |
ImportsPublications |
|
|
FDA Food Importer's
Guide for Low-Acid Canned and Acidified Foods (2001)
Guidance Document |
Booklet. Question-and-Answer guide for importers, low-acid and acidified import requirements. |
| Import Alerts and Detention Reports | Available on the FDA World Wide Web (WWW) server on the Internet. The convention for listing is: |
| Importing Foods into the United States | Flow Chart. A summary of the procedures the U.S. importer must follow when handling food products. |
| Other FDA Web Pages on Imports | |
Low-Acid and Acidified FoodsPublications |
|
|
Low-Acid Canned Foods/Acidified Foods/Good Manufacturing Practice (1997) Guidance Document |
Contains regulations (CFR Parts 108, 113, and 114) on registration and process filing requirements for Low-acid and acidified food processors, emergency permit control, and good manufacturing practices for low-acid canned foods and acidified foods. |
| Better Process Control Schools Schedule | Pamphlet. Schedule of classes held throughout the United States.
These schools certify supervisors of thermal processing systems,
acidification, and container closure evaluation programs for low-acid
canned foods.
Available from: |
| pH Control--Why the Concern? | Explains the importance of correct pH in acidified food processing. Includes regulatory and technical information on acidified foods and pH measurement precautions. |
| FDA Food Importer's Guide for Low-Acid Canned and Acidified Foods (2001) | Booklet. Question-and-Answer guide for importers, low-acid and acidified import requirements. |
| Classification of Visible Can Defects | Poster--24" x 36". A combination of photographs,
easy-to-follow explanations, and color codings to illustrate can
defects, classify them according to degree of potential hazards, and
show what to look for in routine inspection of the finished product.
Source: AOAC International |
| Other FDA Web Pages on: | |
Milk SanitationPublications | |
|
Milk Safety Team | |
| Evaluation of Milk Laboratories 1995 Edition. | Provides the procedures for the evaluation of milk laboratories. |
| Methods of Making Sanitation Ratings of Milk Supplies (1999) | Rating method for evaluating sanitary quality of milk. |
| Procedures Governing the Cooperative State-Public Health Service/ Food and Drug Administration Program for Certification of Interstate Milk Shippers (1999) | Provides procedures for a national reciprocity milk program. Includes by-laws and constitution of the National Conference on Interstate Milk Shipments and the Memorandum of Understanding between the National Conference and FDA. |
| Frozen Dessert Processing Guidelines (1989)
Guidance Document |
Sanitation Standards. |
| Other FDA Web Pages on: | |
Nutrition and Food SciencePublications | |
|
Office of Nutrition, Labeling & Dietary Supplements | |
| Energy Value of Foods--Basis of Derivation | Describes the Atwater method for determining the energy value of food. |
|
FDA Nutrition Labeling Manual -- A Guide
for Developing and Using Data Bases (March 1998)
Guidance Document |
Generic instructions for developing and preparing an acceptable data base when valid estimates of nutrient content and variation are not available for the food (single or mixed products) to be labeled. |
| Guidelines for Determining Metric Equivalents of Household Measures (October 1, 1993) | |
| FASEB Nutrition Reports | Reports on various nutrition topics of current
interest in nutrition labeling and food fortification policies. Available from:
Office of Nutrition, Labeling & Dietary Supplements |
| Other FDA Web Pages on Nutrition | |
ProducePublications | |
| Guide to Minimize
Microbial Food Safety Hazards for Fresh Fruits and Vegetables
(October 26, 1998)
(Also available in French, Spanish, Portuguese and Arabic ) Guidance Document |
|
|
Reducing Microbial Food Safety Hazards For Sprouted Seeds
(October 1999)
Guidance Document |
|
|
Sampling And Microbial Testing Of Spent Irrigation Water During Sprout
Production
(October 1999)
Guidance Document |
|
Retail Food ProtectionPublications | |
| FDA Food Code | A reference that guides retail outlets (restaurants, grocery stores) and institutions (nursing homes) on how to prepare food to prevent foodborne illness. |
| FDA's Application of HACCP to Retail Food Systems | Information Sheet. Provides vital information on Hazardous Analysis and Critical Control Point (HACCP) and the FDA. |
| Food Service Safety Facts: Assuring the Safety of Eggs a
Dishes Made from Raw, Shell Eggs (April 2002) (also available in PDF) |
|
|
Food Labeling:
Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of
Shell Eggs Held for Retail Distribution; Small Entity Compliance
Guide (July 2001)
Guidance Document |
|
| Other FDA Web Pages on Retail Food Protection | |
SanitationPublications | |
| Defect Action Levels (DALS)
(May 1998)
Guidance Document |
Booklet. This list is compiled from FDA's Compliance Policy Guides on established "current levels for natural or unavoidable defects in food for human use that present no health hazards." |
| Inspecting Incoming Food Materials (January, 1999) | Describes the need for inspection of incoming materials. Includes sample inspection report form which can be used as a model for making inspection of incoming food materials. |
| Ecology & Management of Food Industry Pests (1991) | An authoritative illustrated compilation of leading
scientists in the field. It provides alternatives for
managing and controlling insects and other pest
populations attacking food as it moves from the farm to the consumer.
Source: AOAC International |
| Key for Identification of Mandibles of Stored-Food Insects (1985) | An illustrated key that enables analysts to identify
species of insects from all major insect pests found in stored food. Quality control personnel and other scientists involved in food sanitation will find this self-training manual to be a valuable laboratory tool. Source: AOAC International |
| Technical Bulletin No. 1, Principles of Food Analysis for Filth, Decomposition, and Foreign Matter Second Edition (1985) | Provides an overview of the principles, laboratory
techniques, and regulatory aspects of food
sanitation analysis. It explains the why, what, for,
and significance of microscopic analytical techniques.
Source: AOAC International |
| Technical Bulletin No. 5, Macroanalytical Procedures Manual (1984; Electronic version 1998) | |
| FDA Food Code
Guidance Document |
A reference that guides retail outlets (restaurants,grocery stores) and institutions (nursing homes) on how to prepare food to prevent foodborne illness. |
| Do Your Own Establishment Inspection--A Guide to Self Inspection for the Smaller Food Processor and Warehouse (1994) | Step-by-step instructions for doing an inspection, including actual
checklists. Explains advantages of self-inspection. |
| Microanalytical Entomology for Food Sanitation Control Volumes I & II, 1991 Edition | Provides a comprehensive treatise of the micromorphology of food
infesting and contaminating insects. It contains life histories,
distribution information, and keys to identification, as well
as detailed morphological descriptions with diagnostic color
photomicrographs of structural fragments. Source: AOAC International |
| Training Manual for Analytical Entomology | Identifies whole insects, fragments, molds in
foods, and miscellaneous filth. Source: AOAC International |
| Current Good Manufacturing Practice (GMP) | Booklet. Includes provisions for personnel, plants and grounds, sanitary operations, and production and process controls. A reprint of 21 CFR 110 |
| Other FDA Web Pages on Inspections | |
SeafoodPublications | |
| Seafood List (2002) | Booklet. FDA's guide to acceptable market names for seafood sold in the
interstate commerce. Source: Government Printing Office |
| Manual of Operations National Shellfish Sanitation Program (1995) | Part 1-Sanitation of Shellfish Growing Areas Part 2-Sanitation of the Harvesting, Processing and Distribution of Shellfish Both available from:
Food and Drug Administration |
| Other FDA Web Pages on Seafood | |
FDA Headquarter's OfficesThe following offices provide important services to industry | |
| Press releases, general information | Press Office (HFI-21) Office of Public Affairs/FDA 5100 Paint Branch Parkway College Park, MD 20740-3835 (301) 436-2335 |
| Consumer interest publications | 1-888-INFO-FDA (1-888-463-6332) |
| Industry interest publications | Communications and Coordination Branch 5100 Paint Branch Parkway College Park, MD 20740-3835 1-888-723-3366 (1-888-SAFEFOOD) |
| Requests for FDA records covered under the Freedom of Information Act | Freedom of Information Staff (HFI-35) Office of Public Affairs/FDA 5600 Fishers Lane Rockville, MD 20857 (301) 827-6500 (Voice Mail) |
| Maintains the agency's administrative record | Dockets Management Branch (HFA-305) Office of Management and Operations/FDA 5600 Fishers Lane Rockville, MD 20857 (301) 827-6860 |
| FDA 2541- Food Canning Establishment Registration; FDA 2541a. - Food Process Filing for all Methods except Low-Acid Aseptic FDA 2541c.- Filing for Low-Acid Aseptic Systems |
Required filing registration forms for all commercial processors of
low-acid and acidified foods. Request forms and instructions from:
Food and Drug Administration
Telephone: (301) 436-2411 |
Telephone the sources for current prices. Your check or money order should be accompanied by the name of the publication and the order number, if applicable. The following are frequently cited sources; other sources are listed with the corresponding publication above.
Center for Food Safety and Applied Nutrition/FDA
5100 Paint Branch Parkway
College Park, MD 20740-3835
Telephone: 1-888-723-3366 (1-888-SAFEFOOD)
Superintendent of Documents
Government Printing Office
Washington, DC. 20402
Telephone: (202) 512-1800
