Compliance & Enforcement
To protect public health, FDA monitors domestic firms and the foods that they produce. FDA also has multiple initiatives for monitoring imported products and foreign firms exporting to the United States. FDA protects consumers from unsafe foods through:
- Research and methods development
- Criminal prosecution
This section provides access to FDA's warning and untitled letters, information about inspection and compliance programs, and the Reportable Food Registry.
When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter.
Untitled letters address violations from manufacturing controls or labeling that do not meet the threshold of regulatory significance for a Warning Letter. Untitled letters can also be issued to websites.
The Reportable Food Registry is an electronic portal for industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Reportable Food Registry helps FDA better protect public health by tracking patterns and targeting inspections.
Learn about how FDA helps keep food safe through inspections, including the Foreign Food Inspection Program and inspections of aircraft water systems.
FDA's compliance programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the laws administered by FDA.
FDA’s Risk-Based Model for Prioritizing Inspections of Domestic Food Establishments At-a-Glance(PDF - 146KB) Manual of Compliance Policy Guides Compliance Program Guidance Manual (CPGM) Regulatory Procedures Manual
- Methods for Reconditioning Imported Cocoa Beans: Letter to National Confectioners Association’s Chocolate Council
Federal Food, Drug, and Cosmetic Act (FD&C Act) Investigations Operations Manual Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations.(PDF - 143KB)