FDA standards
Food safety rules
FDA standards are the regulations and requirements established by the U.S.
Food and Drug Administration governing the safety, efficacy, and quality of food, drugs, medical devices, cosmetics, and other products under its jurisdiction.
These standards cover everything from manufacturing practices to labeling requirements to acceptable levels of contaminants.
When something meets FDA standards, it has satisfied the agency's criteria for legal sale in the United States.
The facility was shut down for failing to meet FDA standards.
- drug approvalRegulatory clearance for pharmaceuticals
- contaminationIntroduction of impurities
- labelingAssigning identifying markers
- additivesSubstances included for enhancement
- consent decreesCourt-approved resolution agreements
clinical trials · fast track approval · labeling requirements · recalls · inspections · biocompatibility · efficacy · corrective actions · sterilization · allergens · injunctions · bioequivalence · nutrition facts · civil penalties · warning letters · criminal prosecutions · product registration · food safety
FDA standardsunregulated
Not controlled by rules
caveat emptor · honor system · self-certification · deregulation · best practices
FDA standardsblack market
Illicit trading system
underground market · off-label · unapproved · bootleg · counterfeit goods
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