|
(Other Guidance Documents from FDA)
Table of Contents | |
---|---|
General Publications | |
Compliance Policy Guides Manual (2008) |
Consolidates the Administrative Guidelines Manual. Lists levels of
contamination at which regulatory actions will be invoked.
Print version available from NTIS.
Order No. PB2003915400 (2003 edition) |
Compliance Program Guidance Manual (May 2008) | Manual. Contains inspectional and analytical directives
implemented by FDA Field Units. Provides direction for general
enforcement of laws and regulations. Order No. PB95-915499(manual only) |
FDA Recall Policy (2002) | Explains the three classes of recalls and discusses FDA's role in the recall process. Source: Industry Activities Staff |
Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations | |
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. PB2008-913399 |
Regulatory Procedures Manual (March 2008) | Contains directives for recalls, legal actions, and cooperative
agreements with states, such as those under the Public Health Service. Order No. PB2004104960 (2004 edition) |
CosmeticPublications | |
FDA's Cosmetic Labeling Manual (October 1991) | Booklet. A summary of regulatory requirements for
labeling of cosmetics marketed in the United States. Available from:
Food and Drug Administration |
Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance (October 2007) | |
Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients (January 10, 2005) |
Food ProcessingPublications |
|
Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient (March 2009) | |
Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods (February 2008) | |
Bacteriological Analytical Manual 7th Edition (1992) | 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) |
Infant FormulaPublications | |
Frequently Asked Questions about FDA's Regulation of Infant Formula (March 1, 2006) | |
Guidelines Concerning Notification and Testing of Infant Formula (1985) | Source: Office of Nutritional Products, Labeling & Dietary Supplements |
Guidelines for Evaluation of the Safety and Suitability of New Infant Formulas for Feeding Preterm Infants (1988) | Source: Office of Nutritional Products, Labeling & Dietary Supplements |
Clinical Testing of Infant Formulas with Respect to Nutritional Suitability for Term Infants (1988) | Source: Office of Nutritional Products, Labeling & Dietary Supplements |
Guidelines for Evaluation of the Safety and Suitability of Infant Formulas for Feeding Infants with Allergic Diseases (1990) | Source: Office of Nutritional Products, Labeling & Dietary Supplements |
Guidelines for the Clinical Evaluation of New Products Used in the Dietary Management of Infants, Children and Pregnant Women with Metabolic Disorders (1987) | Source: Office of Nutritional Products, Labeling & Dietary Supplements |
Low-Acid and Acidified FoodsPublications |
|
FDA Food Importer's Guide for Low-Acid Canned and Acidified Foods (1985) |
Booklet. Question-and-Answer guide for importers, low-acid and
acidified import requirements. Source: Industry Activities Staff |
Medical FoodsPublications |
|
Frequently Asked Questions About Medical Foods (May 2007) |
|
Milk SanitationPublications |
|
Grade "A" Pasteurized Milk Ordinance 2003 Revision (March 2, 2004) | |
Grade "A" Pasteurized Milk Ordinance 2001 Revision (May 15, 2002) | |
Importation of PMO Defined Dairy Products (M-I-00-4) (April 11, 2000) | |
Evaluation of Milk Laboratories (1995 Edition) | Provides the procedures for the evaluation of milk laboratories. Source: Milk Safety Branch |
Methods of Making Sanitation Ratings of Milk Supplies (1999) | Rating method for evaluating sanitary quality of milk. Source: Milk Safety Branch |
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. Source: Milk Safety Branch |
Frozen Dessert Processing Guidelines (1989) | Sanitation Standards. Source: Milk Safety Branch |
Dry Milk Ordinance (1995) | Source: Milk Safety Branch |
Pasteurized Milk Ordinance (1999) | Source: Milk Safety Branch |
ProducePublications | |
Guide to Minimize
Microbial Food Safety Hazards for Fresh Fruits and Vegetables
(October 26, 1998)
(Also available in French, Spanish, Portuguese and Arabic) |
Source: Food Safety Initiative Staff |
Final Guidance: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (February 2008) | |
Reducing Microbial Food Safety Hazards For Sprouted Seeds (October 1999) |
Source: Office of Plant and Dairy Foods and Beverages |
Sampling And Microbial Testing Of Spent Irrigation Water During Sprout Production (October 1999) |
Source: Office of Plant and Dairy Foods and Beverages |
SanitationPublications | |
Foods -- Adulteration Involving Hard or Sharp Foreign Objects (February 1999) Compliance Policy Guide Chapter 5 Subchapter 555 Section 555.425 | |
Defect Action Levels (DALS) (1995; Revised March 1997 and May 1998) | 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." Source: Industry Activities Staff |
Action Levels for Poisonous or Deleterious Substances in Human Food and Feed (2000) | Source: Industry Activities Staff |
Industry Activities Staff (HFS-565)
Center for Food Safety and Applied Nutrition/FDA
5100 Paint Branch Parkway
College Park, MD 20740
Telephone: (301) 436-2600
Please include a self-addressed mailing label to expedite shipment.
Superintendent of Documents
Government Printing Office
Washington, DC. 20402
Telephone: (202) 512-1800
The Food and Drug Law Institute
1000 Vermont Ave. Suite 1200
Washington, DC. 20005
Telephone: (202) 371-1420
Food Safety Initiative Staff (HFS-32)
Center for Food Safety and Applied Nutrition/FDA
5100 Paint Branch Parkway
College Park, MD 20740
Telephone: (301) 436-2428
Office of Food Additive Safety
Food and Drug Administration (HFS-200)
5100 Paint Branch Parkway
College Park, MD 20740
Telephone: (202) 418-3100
Office of Nutritional Products, Labeling & Dietary Supplements, HFS-800
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
Telephone: (301) 436-2373
Milk Safety Branch, HFS-626
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Telephone: (301) 436-2439
Office of Seafood
Food and Drug Administration (HFS-400)
5100 Paint Branch Parkway
College Park, MD 20740-3835
Telephone: (301) 436-2303
Office of Food Labeling
Food and Drug Administration (HFS-800)
5100 Paint Branch Parkway
College Park, MD 20740
(301) 436-2373