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

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 US$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 US$200 to US$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).

The FDA notes that the prior notice requirements under section 801(m) of the Federal Food, Drug, and Cosmetic Act must continue to be met on all food and feed shipments and that (except in certain cases) there are no exemptions based on a de minimis value or quantity of food. The FDA will continue to work on an updated low-value strategy outlining which FDA-regulated products require notification for determination of admissibility regardless of the value of the shipment upon entry.

The FDA is also rescinding a January 1995 message (CSMS #95-000090) because the instructions therein for electronic declarations are no longer applicable due to the implementation of the Automated Commercial Environment.

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