FDA Review Now Required for all US Imports

Please be advised that as of July 9, 2025, all U.S. imports of Food and Drug Administration (FDA)-regulated products—regardless of value or quantity—must be submitted for FDA review.
The previous exemption for low-value (de minimis) shipments has been revoked. Affected product categories include:
  1. Food
  2. Cosmetics
  3. Dinnerware and cooking utensils
  4. Radiation-emitting electronics
  5. Biological samples
These items can no longer be released by U.S. Customs without FDA notification and clearance. Importers must now ensure that all required FDA data elements—such as product codes, intended use, and manufacturer information—are correctly submitted. For more detailed information on this regulatory update, you can refer to:
  1. The official U.S. Customs and Border Protection (CBP) and FDA guidance here
  2. Our FDA regulated shipment requirements guide here
If you have questions or need support, contact us.
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