The FDA sets scientific standards for testing foods for various contaminants. Laboratories and food companies worldwide use these standards to make sure that food products are safe to eat and drink.
FDA's CFSAN LABORATORY QUALITY ASSURANCE MANUAL (LQM) 3rd Edition (2009) establishes the policies and instructions related to laboratory quality assurance in CFSAN. The manual is a central resource for understanding CFSAN's quality system and provides guidance on quality concepts principles, and practices.
FDA's Bacteriological Analytical Manual (The BAM) is a collection of procedures preferred by analysts in U.S. Food and Drug Administration laboratories for the detection in food and cosmetic products of pathogens (bacterial, viral, parasitic, plus yeast and mold) and of microbial toxins.
This section also contains additional information about other FDA Microbiological Methods.
FDA's Drug & Chemical Residues Methods are procedures preferred by analysts in U.S. Food and Drug Administration laboratories for the detection in food and cosmetic products of drug and chemical residues including:
- Diethylene Glycol and Ethylene Glycol
- Ephedrine Alkaloids
- Malachite Green and Metabolites; Crystal Violet and Brilliant Green
- Melamine and Analogues
The Elemental Analysis Manual (EAM) for Food and Related Products provides a repository of the analytical methods used in FDA laboratories to examine food for toxic and nutrient elements for regulatory purposes. The manual also provides general guidance on related aspects of a laboratory analysis.
FDA Technical Bulletin Number 5
The Macroanalytical Procedures Manual is currently being revised to update its content and add new material. In the interim, we have converted the original 1984 edition of the manual for display on the FDA website. This website version was produced as a cooperative effort between the editors and the Center for Food Safety and Applied Nutrition (CFSAN). Our purpose is to provide access to the out-of-print 1984 manual until the revised edition is available.
FDA is responsible under the Federal Food, Drug, and Cosmetic Act for enforcing tolerances established by the Environmental Protection Agency (EPA) for amounts of pesticide residues that may legally remain on food (including animal feed). In meeting this responsibility, FDA collects and analyzes food from commercial channels of trade for determining compliance with EPA tolerances. Residue data gathered under this regulatory monitoring program are also used for evaluating the extent and significance of pesticide residues in the food supply.
FDA uses these analytical methods to test products to determine if they contain ephedrine alkaloids. This testing is pursuant to the final regulation issued in February, 2004, which declared dietary supplements containing ephedrine alkaloids adulterated. FDA is posting this methodology so the public is aware of FDA's course of action.