FDA Import Alerts, Detentions, Refusals, and Seizures

Summary

This practice note outlines enforcement actions the U.S. Food and Drug Administration (FDA) may initiate to prevent non-compliant regulated products from entering U.S. commerce. Specifically, this practice note covers the FDA's authority over the importation of food, drugs, cosmetics, medical devices, and other regulated products to ensure they meet safety and legal standards. The FDA has several mechanisms to enforce compliance with these standards, including import alerts, detentions, refusals, and seizures.