Notifying FDA on De Minimis Shipments

July 24, 2017
By Danielle Leonard

FDA stamp over container yard

The U.S. Food and Drug Administration (FDA) announced, in a recent CSMS message, that they are in the process of updating the requirements for submitting notification of shipments that qualify under Section 321 of the Tariff Act of 1930. Since the increase in the de minimis value from $200 to $800, the FDA’s reporting requirements for these types of shipments have been unclear.

The update allows for Customs clearance without notifying FDA for products under the previously identified five categories, up to $800. This should reduce costs and processing times for importers bringing in low value items.

The five categories include:

  • 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
  • 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.)

In the same CSMS, the FDA revoked its previous message from 1995, regarding the instructions on how to notify the FDA of low value shipments. The agency took back this statement because the instructions are now outdated since the implementation of ACE.

The FDA will continue to work on updating guidelines for which FDA-regulated products require notification to the agency. In the meantime, if you have any questions contact your Mohawk customer service representative.