|
(Other Guidance Documents from FDA)
Table of Contents | |
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General Publications | |
Compliance Policy Guides Manual (August 2000; Updated April 2001) |
Consolidates the Administrative Guidelines Manual. Lists levels of
contamination at which regulatory actions will be invoked.
Print version available from NTIS. Their order numbers are:
Foods and Cosmetics Order No. PB96-920500 |
Compliance Programs Guidance Manual (March 1995) | 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 |
Draft Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations | |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 (May 1996) | 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 |
Regulatory Procedures Manual (August 1997) | Contains directives for recalls, legal actions, and cooperative
agreements with states, such as those under the Public Health Service. Order No. PB95-265534 |
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 (December 17, 2003) | |
Draft Guidance: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients (December 2, 2002) |
Food ProcessingPublications | |
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 | |
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 |
Milk SanitationPublications | |
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 |
Nutrition and Food SciencePublications | |
FDA Nutrition Labeling Manual -- A Guide for Developing and Using Data Bases (March 1998) |
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.
Source: Office of Food Labeling |
Guidelines for Determining Metric Equivalents of Household Measures (October 1, 1993) | Source: Office of Food Labeling |
List of Products for Each Product Category (October 8, 1992) | Source: Office of Food Labeling |
Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers (June 10, 1996) | Source: Office of Food Labeling |
Guidance on Labeling of Foods that Need Refrigeration by Consumers (February 24, 1997) | 62 FR 8248 Source: Office of Food Labeling |
Interim Guidance on the Voluntary Labeling of Milk and Milk Products that have not been treated with Recombinant Bovine Somatropin (February 10, 1994) | 59 FR 6279 Source: Office of Food Labeling |
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 |
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) | 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.
AOAC International
481 N. Frederick Ave., Suite 500
Gaithersburg, MD 20877-2417
Telephone: (301) 924-7077
National Technical Information
Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
Telephone: 1-800-553-6847
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