These goods now require FDA data submission.

Effective IMMEDIATELY, FDA has rescinded the five product categories that could be released without FDA notification and were previously permitted to be entered as Section 321 (Manifest only clearance).

The five product categories where a release could 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) were:

• 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.

These goods now require FDA data submission and must be filed as an ET86 (other than China origin) or other consumption entry regardless of value.

For more information, click here to continue reading about the products regulated by the FDA.