FDA Offers Guidance on Good Importer Practices

(World Trade Interactive)

The Food and Drug Administration has announced the availability of a draft guidance document draft guidance document that provides general recommendations to importers on possible practices and procedures they may follow to increase the likelihood that the products they import are in compliance with applicable U.S. safety and security requirements. Comments are due by April 13.

According to the FDA, this guidance is intended for use by importers that initiate or cause the entry or attempted entry of foreign-sourced products or the reimportation of U.S.-made products for commercial purposes to help ensure that such products are safe and comply with applicable U.S. requirements.

In general, the recommendations advise importers to know the foreign firms with whom they do business and through which the products they purchase pass, understand the products they import and their vulnerabilities, understand the hazards that may be introduced during the product’s life cycle, and ensure that these hazards have been properly controlled and monitored. Importers should consider instituting practices to identify and minimize risk, put into place controls for known vulnerabilities (e.g., microbiological contamination or product defects), and monitor for other risks (e.g., counterfeiting or intentional contamination).

The FDA states that the good importer practices are broadly organized by four guiding principles: establishing a product safety management program, knowing the product and applicable U.S. requirements, verifying product and firm compliance with U.S. requirements throughout the supply chain and product life cycle, and taking corrective and preventive action when the imported product or firm is not compliant. The guidance suggests specific actions importers can take to accomplish each of these objectives.