FDA Requirements for US Imports

FDA Requirements for US Imports

In line with the latest U.S. FDA customs requirements, please ensure that all shipments containing edibles, cosmetics, or health products are accompanied by the following documents. Missing or incomplete paperwork may result in clearance delays, returns, or seizure of the shipment.

Required FDA Documentation:

  1. Brand name and intended use of the product
  2. Product form (capsules, tablets, liquid, powder, etc.)
  3. Quantity per shipment
  4. Manufacturer’s full legal name and physical address
  5. Product labeling and/or ingredient list
  6. Certificate of Analysis (CoA) and/or MSDS
  7. Manufacturer’s FDA Registration Number
  8. Medical Device Listing Number (if applicable)
  9. Foreign Exporter’s FDA Registration Number
  10. Foreign Supplier Verification Program (FSVP) agreement from the U.S. importer
Submitting these documents in advance will help ensure a smooth FDA review and customs clearance process.