What describes the Good Importer Practices guidance from the FDA?

• A. Importers who initiate or cause entry or attempted entry of foreign-sourced products into the U.S. or reimportation of U.S.-made products for commercial purposes to help ensure that such products are safe and comply with applicable US requirements.
• B. Importers who inspect products at the border
• C. Importers who export U.S.-made products
• D. Importers who label products for sale

Answer: (A)

Good Importer Practices describes the responsibilities of importers who initiate entry or cause entry of products into the United States, or reimportation of U.S.-made products for commercial purposes, with the aim of ensuring those products are safe and compliant with applicable US requirements. This guidance focuses on the importer’s due diligence—verifying suppliers, ensuring proper documentation, maintaining appropriate records, and cooperating with FDA to prevent unsafe or noncompliant products from entering the market. The other activities described—inspecting at the border, exporting U.S.-made products, or labeling for sale—fall outside this importer-facing framework and are not what Good Importer Practices centers on.