Update on FDA Reporting for Low Value Products

News for low value ($800 or less) importers of:

1. Cosmetics;
2. Dinnerware (including eating and/or cooking utensils);
3. Radiation emitting, non-medical devices (e.g. microwaves, televisions, CD players, etc.);
4. Biological samples for laboratory testing;
5. 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.

Pursuant to CSMS #17-000388, “a release may be issued without notification to FDA for the purposes of determining entry admissibility under section 801(a) of the Federal Food, Drug & Cosmetic Act (the Act), if the shipment is valued at or below the current de minimis level (currently $800).”  Sec. 801(a) submission (21 U.S.C. § 381(a)), previously made via FDA Form 701 (CSMS #94-001260), and currently made via CBP Forms 3461/3461ALT/7501 where information is forwarded to FDA through CBP’s Automated Commercial Environment (ACE), provides for examination or sampling of an article offered for import.

This does not mean, however, that $800 or less food shipments are exempt from prior notice (21 U.S.C. § 381(m)) requirements by virtue of its low value.  Low value is not a factor.  But! Prior notice exemption factors – 21 C.F.R. § 1.277 – are:

1. Food for an individual’s personal use when it is carried by or otherwise accompanies the individual when arriving in the United States;
2. Food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for nonbusiness reasons) to an individual in the United States;
3. Food that is imported then exported without leaving the port of arrival until export;
4. Meat food products that at the time of importation are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
5. Poultry products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Poultry Products Inspection Act (21 U.S.C. 451 et seq.);
6. Egg products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.); and
7. Articles of food subject to Article 27(3) of The Vienna Convention on Diplomatic Relations (1961), i.e., shipped as baggage or cargo constituting the diplomatic bag.

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