Food Import FDA Compliance

The Foreign Supplier Verification Program (FSVP) is an FDA regulation requiring US importers to verify that food they import meets US safety standards. You must comply if you import food (including dietary supplements) into the US, unless an exemption applies. FSVP requires you to conduct hazard analysis, evaluate suppliers, perform verification activities, and maintain records. Failure to comply can result in import refusals and warning letters.

Prior Notice must be submitted to FDA before food arrives at a US port of entry. The notice must include information about the article of food, manufacturer, shipper, grower (if known), country of origin, and anticipated port and date of arrival. Timeframes vary: 15 days maximum advance notice, and minimum 2-4 hours depending on transportation mode. Submit via FDA's Prior Notice System Interface (PNSI) or ABI/ACS for electronic entry.

Yes, foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the US must register with FDA before food from that facility can be imported. Registration is free and must be renewed every two years (October-December of even years). The foreign facility must also designate a US Agent. Failure to register results in automatic detention of shipments.

FSVP requires verification activities appropriate to the food and supplier. Options include: (1) onsite audits of the supplier, (2) sampling and testing of the food, (3) review of supplier's relevant food safety records, or (4) other activities that provide equivalent assurance. The type and frequency depend on your hazard analysis and the supplier's performance history. At minimum, you must evaluate suppliers every 3 years.

If FDA refuses entry, your shipment cannot enter US commerce. You'll receive a Notice of FDA Action explaining the reason. Options include: (1) export or destroy the shipment within 90 days, (2) request reconsideration if you believe the refusal was in error, or (3) submit a reconditioning plan if the violation can be corrected. Frequent refusals can result in Import Alert listing, requiring future shipments to demonstrate compliance before release.

Yes, limited exemptions exist: (1) Food for personal consumption, (2) Food imported for research/evaluation, (3) Alcoholic beverages (except for certain hazards), (4) Food from suppliers in countries with equivalent food safety systems, (5) Very small importers (modified requirements), (6) Food complying with customer's Preventive Controls or HACCP plan. Even exempt importers may need to meet modified FSVP requirements.

FSVP requires records of: hazard analysis, supplier evaluation, verification activities performed, corrective actions taken, and your review of these activities. Records must be kept for at least 2 years and be available within 24 hours if FDA requests them. Electronic records are acceptable. Records must be in English or have English translations available.

An Import Alert is an FDA enforcement mechanism that can detain shipments without physical examination. If your supplier or product is on an Import Alert, shipments may be automatically detained until you demonstrate compliance. Types include: Red List (specific firms), Green List (firms exempt from alert), and Countrywide alerts. Check FDA's Import Alert database before selecting suppliers.