FDA Clarifies Expectations for Section 321 Entries
The Food and Drug Administration updated a 1994 notice that identified categories of products that can be released by CBP without FDA notification when under the de minimis value (Section 321) to reflect some recent changes, the agency said in a CSMS message (here). While the FDA already updated a regulatory procedural manual after the CBP de minimis threshold was increased from $200 to $800 (here), that 1994 notice was due for an update, it said. "Based on conversations with stakeholders, FDA reporting requirements for de minimis shipments were unclear given FDA’s legacy CSMS messages on such low value shipments," it said.
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The same previously identified product categories can be released without notification to the FDA when the value is under $800, it said. Those 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." The agency also rescinded the previous message because it includes some outdated instructions, it said. "FDA will continue to work on an updated low value strategy outlining which FDA-regulated products require notification to the Agency for determination of admissibility, regardless of the value of the shipment upon entry," it said. A CBP official recently said similar messages from other agencies would be helpful (see 1706210071).