FDA's role in imports
The US Food and Drug Administration regulates approximately 20 cents of every consumer dollar spent in the United States. For importers, this means a vast range of products require FDA clearance before they can enter the country, including food and beverages, dietary supplements, pharmaceuticals and biologics, medical devices, cosmetics, tobacco products, and animal feed and veterinary products.
FDA import violations can result in product detention, refusal of admission, and destruction of goods at the importer's expense.
Prior notice requirements
For food imports, FDA requires prior notice before the shipment arrives. This electronic notification must be submitted to FDA no less than 15 days and no more than 30 days before the anticipated arrival for food arriving by ocean, and no less than 4 hours before arrival for food arriving by air.
Prior notice must include a description of the article, the manufacturer and shipper, the grower if applicable, the country of origin, the anticipated arrival information, the entry type, and the name of the importer.
Facility registration
Any facility that manufactures, processes, packs, or holds food for consumption in the United States must be registered with FDA. This includes foreign facilities. Registration must be renewed every two years during the October to December renewal window.
Failure to maintain an active facility registration can result in automatic detention of shipments from that facility.
Product-specific requirements
Food products
Food imports face the most scrutiny. Requirements include FSVP (Foreign Supplier Verification Program) compliance where importers must verify that their foreign suppliers produce food meeting US safety standards. Certain products require Lacey Act declarations, USDA inspection for meat and poultry, and compliance with food labeling regulations.
Pharmaceuticals
Drug imports face strict controls. Only FDA-approved drugs may be imported. The manufacturer must be registered with FDA and the drug manufactured in compliance with Current Good Manufacturing Practice (cGMP). An active Drug Listing is required.
Medical devices
Medical device imports require that the device has appropriate FDA clearance or approval such as 510(k), PMA, or De Novo classification. The foreign manufacturer must be registered with FDA and listed. Devices must be labeled in compliance with FDA requirements.
Common reasons for FDA detention
Products are commonly detained for labeling violations where labels do not meet US requirements, adulteration where products contain prohibited substances or are manufactured under unsanitary conditions, missing or expired registrations, lack of prior notice filing, and failure to comply with import alerts that flag certain products, manufacturers, or countries for increased scrutiny.
How to prevent FDA issues
Work with suppliers who understand US FDA requirements. Have labels reviewed for compliance before production. File prior notice early and accurately. Maintain current facility registrations. Monitor FDA import alerts for your product categories. Consider a third-party testing program to verify product safety before shipment.
ASR handles FDA-regulated imports
Our customs clearance team has extensive experience clearing FDA-regulated products including food, supplements, cosmetics, and medical devices. We coordinate prior notice filing, document review, and FDA communication to minimize delays. Contact us at shipping@asrwe.com or +1 786 373 3003.
