FDA Updates Policy on Release Without Notification to Reflect Current De Minimis Level


Sandler, Travis & Rosenberg 2017-07-06

The Food and Drug Administration has updated previously issued guidance to clarify that FDA-regulated goods in five categories may be released without notification to the FDA for the purpose of determining admissibility if the shipment is valued at or below the de minimis amount of $800. That amount – the value of goods that may be imported by one person on one day free of duty and tax – was increased from $200 to $800 by a provision in the Trade Enforcement and Trade Facilitation Act of 2015.

The product categories that qualify for this policy are cosmetics, dinnerware (including eating and/or cooking utensils), radiation-emitting non-medical devices (e.g., microwaves, televisions, CD players), biological samples for laboratory testing, and food (excluding ackees, puffer fish, raw clams, raw oysters, raw mussels, and foods packed in airtight containers intended to be stored at room temperature).

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