Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 6.7 - GLOSSARY OF IMPORT TERMS
Refer to the Regulatory Procedures Manual Chapter 11 "Glossary" for a more complete listing of import terms. Below is some common import language:
Goods produced in the U.S. which are exported, and then returned to the U.S. They are considered imports. (See Sec. 801(d)(1)of the FD&C Act [21 U.S.C. 381]).
One of several classes of Customs Warehouses authorized to receive goods that have not been entered into the commerce of the US. Goods are entered into a Customs Bonded Warehouse (CBW) by a "formal entry" or "warehouse entry" requiring complete documentation for the entry, and payment of a fee, but not payment of duty and taxes. Goods in the warehouse can be held for up to 5 years. After 5 years the goods must be entered, exported, or destroyed. Goods in a CBW can be manipulated, but except in certain smelting operations, cannot be manufactured into something else. If the CBW is located in the US, the goods are in interstate commerce and subject to the FD&C Act. See CPG Sec. 110.600 FDA Authority Over Products of Foreign Origin Located in Foreign Trade Zones, Bonded Warehouses or on Bonded Carriers.
Cargo transported in individual units, such as bags or cartons, which are not containerized.
"Entered for Consumption" means an entry summary for consumption has been filed with CBP in proper form, with estimated duties attached. The duty can be submitted electronically at the same time as the entry is transmitted or on a 15 day schedule when approved by CBP.
Another location authorized to receive goods under Customs Bond for the purpose of breaking bulk and redelivery of cargo. Containerized cargo can be moved from the place of unlading to a designated container station, or may be received directly at the container station from a bonded carrier after transportation in-bond, before the filing of an entry of goods.
The date an import sample is collected.
The date a carrier transporting imported cargo arrives in the U.S.
The date imported cargo is available/accessible for sampling by FDA. Goods may not be available for sampling as soon as they arrive in the U.S., due to the way the items were shipped/stored.
A temporary administrative action taken by FDA against articles offered for entry which are not or appears not to be in-compliance with the laws FDA administers. Detained articles can be released if brought into compliance, or are refused entry or seized, if not brought into compliance.
An action directed against specific products manufactured or shipped by specific foreign firms. "Import Alerts" list products which may be detained without physical examination due to their violative history or potential.
A sample of an imported article collected after it has been released from import status. See IOM 188.8.131.52.
Delivery or offer for delivery of merchandise into the Customs Territory of the U.S. from an outside point.
Entry admissibility file refers to the file, hard copy and/or electronic, as appropriate, maintained by the District, which contains relevant documentation to support the District's admissibility decision.
Information submitted to CBP to determine the goods quantity, its contents, and the parties of interest. Actual documentation for an individual entry can vary greatly, but it generally, consists of a CBP Form CF-3461, and an invoice. Entry documents can be submitted by paper, or through an electronic transmission in CBP’s Automated Commercial System (ACS), or a combination of both. Upon request to the importer or filer, the can submit the entry documents electronically to FDA via the Import Trade Auxiliary Communications System (ITACS).
Failure to hold means that the goods have been distributed by the importer/consignee without an FDA release from import status. Such goods are usually subject to CBP's redelivery provisions. See IOM 6.7.31 - REDELIVERY BOND.
A CBP term used to identify the individual or firm responsible for filing an entry. Also known as a Customs House Broker.
The entry type required for shipments valued over $2000 or for shipments containing specific commodities designated by CBP. Formal entry is usually a three-step process, "Entry" - which gains the release of the goods from CBP control, "Entry Summary" - which includes determination of the classification and collection of the duty/taxes owed, and "Liquidation" - which is the finalization of the entry process and the completion of an CBP changes to classification and monies owed.
Foreign Trade Zones (FTZ) are established under the Foreign Trade Zones Act. Goods properly admitted into an FTZ is considered outside the territory of the US for the purposed of duty and taxes. Several classes of goods are present in an FTZ at any one time. Some of these classes provide duty advantages when the goods are eventually entered into the commerce of the US. Other classes of goods are prohibited by law from entering the commerce and must be exported or destroyed. There is no time limit on how long goods can remain in a FTZ without entry or export. If the FTZ is located in the US, the goods are in interstate commerce and subject to the FD&C Act. See CPG Sec. 110.200 Export of FDA Regulated Products from U.S. Foreign Trade Zones
Entry/Immediate Delivery (CF 3461) must be filed within 15 calendar days of arrival of goods in the U.S. Goods may be released for immediate delivery if it is arriving by land from Canada and Mexico. Products may be released for immediate delivery pending entry process completion. Even though CBP has allowed the immediate delivery, FDA regulated products are conditionally released until FDA makes an admissibility decision. The conditional release period ends when FDA May Proceeds the entry or issues a refusal.
Import Alerts are guidance documents concerning significant re-occurring, new, or unusual problems affecting import coverage. They are available on the internet at www.fda.gov/ora/fiars/ora_import_alerts.html.
The party in whose name the entry is made. For example, a Customs House Broker might make an entry and become the "importer of record" by using his importer ID and bond on behalf of his client, the true "importer" of the goods. For FDA purposes, the "importer of record" is the person or company filing the redelivery bond under Sections 802(b) and 536(b) of the FD&C Act [21 U.S.C. 382(b) and 360mm(b)].
Import Status is the standing of an article in the import database system which has not yet been released.
Importer misdeclaration refers to the importer's providing incorrect and/or incomplete information to FDA and CBP, usually via the filer. This may include incorrect product codes and/or product descriptions; incorrect/incomplete manufacturer/shipper name/address; incorrect quantity and value. It may occur as an attempt to avoid FDA and/or CBP actions/regulations such as DWPE, sampling, duties, etc.
A simplified import entry procedure accepted at the option of CBP for any shipment not exceeding a specified value. Informal entries are filed with complete paperwork and any duties and taxes are paid at the time of filing. The entry liquidates at time of filing.
An entry document filed with Customs by the importer. It allows the immediate transport of goods without a determination of admissibility, from the port of unloading under Customs bond. In general, the importer must file a consumption entry within 6 months of the date of importation or export the goods. FDA typically examines these goods at an inland port of entry.
A line is each portion of an entry which is listed as a separate item on an entry document. An importer may identify goods in an entry in as many portions as he chooses, except each item in the entry having a different tariff description and rate must be listed separately.
A lot is an entry, group of entries, or a portion of an entry of goods which can clearly be defined as appropriate for FDA sampling and examination purposes.
Words or symbols, usually including the country of origin, marked on cartons, bags, and other containers of imported goods for identification purposes. Marks are a Customs requirement.
A port is the Customs location where the Consumption Entry is made. This may or may not be at the Port of Unloading (the point of physical entry into the U.S.)
A bond posted by the importer of record with Customs. For FDA regulated products, this is currently in the amount of three times the value of the imported product, to insure redelivery of the product for examination, reconditioning, export, or destruction.
Stripping is the removal of articles from transportation "Container" for examination or sampling.
Substitution is an attempt by the importer/consignee to present goods to the FDA as corresponding to a particular entry when they are in fact not the goods from that entry. May occur as an attempt to hide distribution without an FDA release and avoid CBP bond actions. See IOM 6.7.15, FAILURE TO HOLD.
Supervisory charges are the charges for FDA supervision of the reconditioning and examination of articles after detention. (See 21 CFR 1.99).
An entry document filed with Customs by the importer which allows the goods to go immediately into a bonded warehouse.