U.S. Customs and Border Protection has announced that, effective July 9, imports of all products regulated by the Food and Drug Administration must be submitted to the FDA for review regardless of value.
For more than 30 years de minimis shipments of the following FDA-regulated products have been eligible for release by CBP without FDA review for the purposes of determining entry admissibility.
- 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
However, CBP states that because the technological capabilities of both the trade and the FDA have advanced significantly, the FDA can now review all electronically transmitted FDA-regulated products offered for import, regardless of shipment quantity and value, to facilitate legitimate trade and prevent the importation of violative products.
As a result, all prior communications exempting low-value FDA-regulated products from partner government agency filing requirements have been rescinded.
ST&R attorney Lenny Feldman was cited in International Trade Today as saying the FDA “should be able to handle the additional volume” of filings expected to result from this change.
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