U.S. FDA Issues Updated Import Guidance for Low Value (Section 321) Shipments

The U.S. Food & Drug Administration (FDA) recently updated its guidance around qualifying imports valued at $800 or less (“Section 321” or “de minimis”) containing articles regulated by the agency.

It reiterated that only five categories may be released by U.S. Customs without notification to the FDA for the purpose of determining entry admissibility, if valued at or below $800 USD. Those five categories are:

  • Cosmetics;
  • Dinnerware (including eating and/or cooking utensils);
  • Radiation emitting, non-medical devices (e.g. microwaves, televisions, CD players, etc.);
  • Biological samples for laboratory testing; and,
  • Food, excluding ackees, puffer fish, raw clams, raw oysters, raw mussels, and foods packed in air tight containers intended to be stored at room temperature.

All other articles must meet current FDA import requirements regardless of value. FDA Prior Notice requirements must also be met on applicable food and feed imports regardless of value or quantity.

U.S. importers of FDA regulated products are strongly encouraged to review this information closely to ensure their ongoing compliance with applicable requirements. In general, importers are reminded to ensure they meet applicable ‘other government agency’ import requirements regardless of shipment value or quantity.

Please contact your local Delmar International representative or our Advisory Services Group for additional information.

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