Foreign Trade Zones/Weekly Entry Filing
Overview
This page provides an overview of foreign trade zones (FTZ), the process for weekly entry filing (WEF), and information on the process for submitting a request for a preliminary admissibility assessment of FDA-regulated products that would be included in a WEF.
- What is a foreign trade zone (FTZ)?
- Where are FTZs currently located?
- What is weekly entry filing (WEF)?
- What FDA-regulated products may be amenable to a positive preliminary admissibility assessment?
- Where do I submit my request for a preliminary admissibility assessment?
- What information should be submitted in my request for a preliminary admissibility assessment?
- What happens to my request once it has been submitted to the FDA?
- What is the outcome of the FDA review?
- Can products that received a positive preliminary assessment for a WEF be subsequently reviewed and removed from participation?
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 adjacent to CBP ports of entry.
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 Customs duties 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the admissibility of products brought into the FTZ; rather, FDA will make an admissibility decision when products are withdrawn from the FTZ for consumption.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.
Where are FTZs currently located?
FTZs are located in all 50 states and Puerto Rico. Visit Trade.gov for a list of zones by state.
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.
While CBP is ultimately responsible for accepting or rejecting a WEF, FDA may also review WEF requests to help facilitate CBP’s determination. FDA does this by providing a preliminary admissibility assessment on the FDA-regulated products.
For additional information on requests for a preliminary admissibility assessment of FDA-regulated products that would be included in a weekly entry filing (WEF), please refer to Compliance Policy Guide (CPG) Sec 110.650 Weekly Entry Filing: Guidance for Industry and FDA Staff.
What FDA-regulated products may be amenable to a positive preliminary admissibility assessment?
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 an FTZ.
Where do I submit my request for a preliminary admissibility assessment?
Requests for a preliminary admissibility assessment for FDA-regulated articles in a WEF should be submitted to WEFrequest@fda.hhs.gov.
What information should be submitted in my request for a preliminary admissibility assessment?
Submit the most current FDA WEF Product List Spreadsheet listing all products and data included in the request. Data elements submitted are listed below:
- Type of activity being performed (stored or manufactured) in the FTZ
- FTZ No. and Location (address) of where product(s) are stored or manufactured
- Port of Entry
- Port Code
Below is the general information submitted for all commodities:
General Information for All Commodities |
|
---|---|
Firm Information |
Name, address, and (if known) the Facility Establishment Identifier (FEI) for the following firms related to the product being withdrawn from the FTZ:
Note: The manufacturer's registration number is required, when applicable. |
Product Information |
|
Below is the commodity specific information:
Commodity |
Additional Information * |
---|---|
Human Food |
|
Tobacco Products |
|
Animal Food & Feed |
|
Biologics, including CBER regulated drugs, medical devices and licensed biologics |
|
Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) |
|
Cosmetics |
|
Human Drugs |
|
Animal Drugs |
|
Medical Devices/In-vitro Diagnostic Products |
|
Radiological Health/Electronic Products Subject to a Performance Standard |
|
* Additional information may be requested upon further review.
What happens to my request once it has been submitted to the FDA?
The FDA import division office reviews the request for completeness and contacts the requester if additional documentation or data are needed.
The import division also conducts a compliance review to verify:
- Products are compliant with all applicable FDA requirements;
- Manufacturers of these products are compliant with any applicable registration requirements; and
- Neither the products nor the firms (i.e. manufacturers of the products, shipper, etc.) that will participate in the weekly entry filing process have a history of non-compliance.
A review of the request may also be required by the applicable FDA center to determine if the products are amenable for WEF.
What is the outcome of the FDA review?
Once the FDA has completed the preliminary admissibility assessment, the requester will receive notification from the FDA import division office indicating the outcome of the assessment.
For products that have received a positive FDA preliminary assessment, FDA will adjust its import screening system to allow for automated processing of future FTZ withdrawal entries. This may allow for entries participating in WEF to be given an FDA system “May Proceed.”
If the FDA finds that the products are not amenable for WEF or compliance issues are found, future FTZ withdrawal entries (entry type 06) will be processed in the same manner 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.
If the FDA reviews an entry that is later found to be part of a weekly entry filing approved by CBP that has not undergone an FDA preliminary admissibility assessment, the FDA may request CBP to order redelivery of the articles, particularly if FDA has safety concerns.
Can products that received a positive preliminary admissibility assessment for WEF requests be subsequently reviewed and removed from participation?
Yes, if products appear to be violative or are no longer amenable for WEF after a positive preliminary admissibility assessment, the FDA import division will evaluate if the products should be removed from WEF. Violative products collected or violative conditions observed during an inspection of the FTZ site can also result in a review of the WEF request.
Additional Information:
- For more information regarding FTZs, please refer to the CBP manual.
- FDA WEF Product List Spreadsheet
- Presentation on FDA & FTZs