Filth and Extraneous Materials Program
The Food and Drug Administration (FDA) is responsible for promoting and protecting the public's health by helping manufacturers market food that is safe, sanitary, wholesome, and honestly labeled.
The filth and extraneous materials program at the FDA supports the agency’s mission by ensuring manufacturers comply with the Federal Food, Drug, and Cosmetic Act and by preventing adulterated foods from reaching consumers.
Extraneous materials include any foreign matter in a product associated with objectionable conditions or practices in production, storage, or distribution. Examples of filth may include any objectionable matter contributed by animal contamination such as rodent, insect, or bird matter; or any other objectionable matter contributed by insanitary conditions.
Some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. The FDA establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action (21CFR 110.110(a)).
Resources
Regulatory Guidance:
- Food Defect Levels Handbook
- Compliance Policy Guides - Food, Colors, and Cosmetics
- Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements
Inter-Agency Resources:
- MOU 225-72-2001 | FDA Imported dates and date products
- MOU 225-73-2007 | FDA Imported raisins
- MOU 225-80-2000 | FDA Domestic grain, rice, and pulses
Industry:
Testing/Methodology:
- Macroanalytical Procedures Manual (MPM)
- Field Science - Laboratory Manual
- Private Laboratory Testing