For Industry

Foreign Trade Zones/Weekly Entry Filing

Overview

This page provides an overview of foreign trade zones, the process for weekly entry filing, and information on the process for submitting a request for weekly entry filing processing.  

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What is a foreign trade zone (FTZ)?

Foreign-Trade Zones (FTZ) are secure areas under U.S. Customs and Border Protection (CBP) supervision that are generally considered outside CBP territory upon activation. Located in or near CBP ports of entry, they are the United States' version of what are known internationally as free-trade zones.

The FTZ program was designed to promote American competitiveness by encouraging companies to maintain and expand their operations in the United States.  The FTZ program encourages U.S.-based operations by removing certain disincentives associated with manufacturing in the United States.

Because FTZs are considered to be outside the Customs territory for the purpose of tariff laws and Customs entry procedures (even though the FTZ is in the U.S.), the import provisions found in Section 801 of the Federal Food, Drug, and Cosmetic Act (the Act) are not applied to foreign products brought into the FTZ. This means that FDA does not determine the admissibility of products brought into the FTZ; rather, FDA will make an admissibility decision when products are withdrawn from the FTZ for consumption.   

Although FDA does not make an admissibility decision when products are brought into the FTZ, FDA does still have jurisdiction over those products. For purposes of the Act, products located within FTZs are regulated under the domestic provisions of the Act until they are offered for entry. Once offered for entry, they are regulated under the import provisions found in Section 801 of the Act. You can find more information regarding FDA’s authority over products located in foreign trade zones in FDA’s Compliance Policy Guide 110.200 and Compliance Policy Guide 110.600.

You may also visit CBP’s website for more information on Foreign Trade Zones.

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Where are zones currently located?

There are zones in all 50 states and Puerto Rico.  Visit Trade.gov for a list of zones by state.

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What is weekly entry filing (WEF)?

CBP has implemented a weekly entry filing (WEF) program allowing customs brokers (entry filers) to submit a weekly estimate for repetitive, high volume entries of low-risk products.  Under this program, a customs broker (entry filer) can submit a single entry estimating the amount of product that will be withdrawn from the FTZ and offered for consumption into the U.S. during the subsequent week.

Some FDA regulated products may be entered via a WEF process. To do so requires a separate request to FDA for participation in WEF processes, and granting of this request. If the request is granted, entries filed under an FDA granted WEF request would not typically be subject to redelivery for sampling or examination by FDA.

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What FDA-regulated products may be amenable for WEF processing?

Products that are

  • evaluated on a case by case basis and determined by the responsible FDA product center to be “low risk”;
  • in compliance with applicable statutory and regulatory requirements;
  • manufactured, sourced, and/or imported by firms with a history of compliance with FDA regulations; and
  • withdrawn for consumption from a single foreign trade zone.

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Where do I submit my request to participate in WEF processing?

Requests to participate in the weekly entry filing (WEF) process are submitted to the FDA Import Division Office covering the intended port of entry.  Find an FDA Import office near you.

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What information is submitted in my request to participate in WEF processing?

Submit an FDA WEF Product List Spreadsheet listing all products and data elements included in the request. Data elements submitted are listed below:

  1. Supply the following information regarding the zone:
  2. Below is the general information submitted for all commodities:
    General Information for All Commodities 
    Firm Information
    • Name
    • Address
    • Manufacturer Identification Code (MID)
    • Facility Establishment Identifier (FEI) of the Manufacturer, Consignee and Shipper of the product withdrawn from the FTZ
      • For goods manufactured in an FTZ report the site-specific foreign manufacturer of the highest valued, non-U.S., FDA-regulated ingredient or component of the product to be withdrawn from the FTZ
    • Name, address, Importer Number [Box 9 of CBP Form 3461] and FEI of the Importer of Record
    • Firm Registration Number. Some exceptions are:
      • Cosmetics - voluntary
      • Tobacco - currently not required
    Product Information
    • Commercial product name;
    • Product description;
    • FDA product code;
    • Harmonized Tariff Schedule (HTS) code;
    • Country of Origin of the product(s) withdrawn from the FTZ
      • For goods manufactured in a FTZ, report the country of origin of the highest valued, foreign component/ingredient manufacturer

Below is the commodity specific information:

CommodityAdditional Information *
Human Food

 Products will be evaluated on a case by case basis.

Tobacco Products
  • No additional requirements. Products will be evaluated on a case by case basis.
Animal Food & Feed
  • No additional requirements.  Products will be evaluated on a case by case basis.
Biologics, including CBER regulated drugs, medical devices and licensed biologics
  • CBER has determined that licensed biological products, CBER-regulated drugs, and CBER-regulated medical devices are not amenable for WEF processing.
Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
  • CBER has determined that HCT/Ps are not amenable for WEF processing.
Cosmetics
  • No additional requirements.  Products will be evaluated on a case by case basis.
Human Drugs
  • CDER is not approving human drug products for WEF processing at this time.
Animal Drugs
  • Drug Listing Number
  • Application Number
  • Registration Number

 Products will be evaluated on a case by case basis. 

Medical Devices/In-vitro Diagnostic Products
  • CDRH has determined that medical devices and in-vitro diagnostics products are not amenable for WEF processing.
Radiological Health/Electronic Products Subject to a Performance Standard
  • Accession Number. 
  • Below is a list of products and their product codes identified as low risk and which may be amenable for WEF processing:
    •  Product Code: RFU - Laser Fax Machine

      A printing machine that incorporates a laser utilized in printing facsimiles of images on paper.
    • Product Code:  RFV - CD, CD-ROM Player

      A CD or CD-ROM player that utilizes a laser to read data on the compact disc.
    • Product Code:  RFW - DVD, DVD-ROM, BluRay, HD Player

      A DVD, DVD-ROM, Blu-ray, or high definition (HD) player that utilizes a laser to read data on the digitally recorded video disc.
    • Product Code:  RFX – CD-R, CD-RW Recorder

      A CD-R or CD-RW recorder machine that utilizes a laser to read and/or write data on the compact disc.
    • Product Code:  RFY - DVD, BluRay, Or HD Recorder

      A DVD, Blu-ray, or HD recorder machine that utilizes a laser to read and write or read, write, and erase data on a digitally recorded video disc in any of the data formats: DVD- R, DVD+R, DVD-RAM, DVD-RW, or DVD+RW, or Blu-ray or HD recorders or read/writers.
    • Product Code:  RGA - Product Incorporating Certified Class 1 Data Utility/Peripheral Laser Product

      A utility/peripheral laser product that incorporates a certified class 1 laser.

Additional low-risk electronic products subject to a performance standard may be considered on a case by case basis.

 

 

* Additional information may be requested upon further review.

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What happens to my request for WEF processing once it has been submitted to the FDA Import Division office?

The FDA import division office reviews the request to participate in WEF processing for completeness and contacts the WEF requestor if additional documentation or data elements are needed.

The import division also conducts a compliance review to verify:

  • Products are compliant with all applicable FDA requirements;
  • The manufacturers of these products are compliant with any applicable registration requirements; and
  • Neither the products nor the firms that will participate in the weekly entry filing process (i.e manufacturers of the products, shipper, etc.) have a history of non-compliance.

A review of the request for WEF processing may also be required by the applicable FDA center to determine if the products are amenable for WEF procedures because they are “low risk.”  

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What is the outcome of the FDA review?

Once a decision to grant or deny the request for WEF processing is made, you will receive notification from the FDA import division office indicating the request has been granted or denied.

If the request for WEF processing is granted, FDA will adjust FDA OASIS system screening, to allow for automated processing of future Foreign Trade Zone withdrawal entries (entry type 06). That will allow entries participating in WEF to be given a system “may proceed”.

If the request for WEF processing is not granted, future Foreign Trade Zone withdrawal entries (entry type 06) will be processed the same as other entries. This means that those entries will require submission of entry data at the time of actual withdrawal, and may be subject to document review, field examination and/or sample collection.

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Can products participating in WEF be subsequently reviewed and removed from participation?

Yes, if after a request for WEF processing is granted a product later appears to be violative, or if the product appears violative at the time of entry, the FDA import division will evaluate whether continued WEF processing is appropriate. Any violative products collected, or conditions observed during an inspection of the FTZ site, will also cause a review of the WEF request.

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Additional Information:

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Page Last Updated: 09/10/2018
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