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
• Inspection
• Sampling
• Recall
• Seizure
• Injunction
• Criminal prosecution

This section provides access to FDA's warning and untitled letters, information about inspection and compliance programs, and the Reportable Food Registry.

CFSAN Adverse Event Reporting System (CAERS)

A database that contains information on adverse event and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics.

Warning Letters

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

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.

Reportable Food Registry

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.

Inspections

Learn about how FDA helps keep food safe through inspections, including the Foreign Food Inspection Program and inspections of aircraft water systems.

Sampling

The FDA Food Safety Modernization Act is based on preventing problems before they happen, rather than solely responding to outbreaks of foodborne illness. But in order to develop prevention-based systems, you need data and other information to help identify hazards that need to be addressed and minimized. Sampling is an important method for gathering data and information.

Food Compliance Programs

FDA's compliance programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the laws administered by FDA.