FDA 101

We want to put together the following guide to help manufacturers understand how to get your product distributed in the US. This is a basic checklist that is not meant to be exhaustive. You can visit the FDA site or contact us for further details.

Things to keep in mind if you are looking to break in to the US market

1. FDA is not authorized under the law to approve, certify, license, or otherwise sanction individual food importers, products, labels, or shipments.

2. Any product can be imported into the US if the following criteria are met

  • The foods meet US safety standards
  • All packaging has FDA compliant ingredient and nutrition labels
  • The facility (manufacturer) needs to be registered with the FDA
  • The importer/distributor that warehouse the goods needs to be registered with the FDA
  • Prior notice of all shipments needs to be provided to the FDA
  • Importer/Distributor needs copies of all registration paperwork from manufacturer in case of audit

3. The FDA reserves the right to amend or add new rules aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically.