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.
- What is a foreign trade zone (FTZ)?
- Where are zones currently located?
- What is weekly entry filing (WEF)?
- What FDA-regulated products may be amenable for WEF processing?
- Where do I submit my request to participate in WEF processing?
- What information is submitted in my request to participate in WEF processing?
- What happens to my request for WEF processing once it has been submitted to an FDA Import Division office?
- What is the outcome of the FDA review?
- Can products participating in 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the admissibility of products brought into the FTZ; rather, FDA will make an admissibility decision when products are withdrawn from the FTZ for consumption.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.
There are zones in all 50 states and Puerto Rico. Visit Trade.gov for a list of zones by state.
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.
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.
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.
Submit an FDA WEF Product List Spreadsheet listing all products and data elements included in the request. Data elements submitted are listed below:
- Supply the following information regarding the zone:
- Below is the general information submitted for all commodities:
General Information for All Commodities
- 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
- 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:
Additional Information *
- Food Facility Registration Number for those firms required to register with FDA
- Food Canning Establishment (FCE) Number (for Acidified Food (AF) and Low Acid Canned Food (LACF) products)
- Schedule Identifier (SID) number for the scheduled process filed with FDA (for AF and LACF products)
- Below is a list of food related items and a portion of the product code that may be amenable for WEF processing:
- 52A*** - Foodware, Cookware and Tableware
- 52B*** - Miscellaneous Food Related Items (except product "04 - water related to shellfish growing areas")
- ***Denotes any selection available within designated industry and class combination.
- Additional food related products within industry code 52 that are not on the list above are not amenable for WEF processing.
- All other food products will be evaluated on a case by case basis.
- CTP has determined that tobacco products are not amenable for WEF processing.
Animal Food & Feed
- Food Facility Registration Number for those firms required to register with FDA.
- 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.
- No additional requirements.
- Below is a list of cosmetic related products and a portion of the product code that may be amenable for WEF processing:
- 53B*** - Cosmetics/Bath Prep
- 53Q*** - Cosmetics Packaging/Labeling
- 53P*** - Cosmetics Raw Material
- 53D*** - Cosmetics Fragrance Prep
- 53F*** - Cosmetics Hair Coloring Prep
- 53E*** - Cosmetics Hair Preps (Non-Coloring)
- 53G*** - Cosmetics Makeup Prep (Not For Eyes)
- 53H*** - Cosmetics Manicuring Prep
- 53J*** - Cosmetics Personal Cleanliness
- 53K*** - Cosmetics Shaving Prep
- 53L*** - Cosmetics Skincare Prep
- 53M*** - Cosmetics Suntan Prep
- 53Y*** - Cosmetics and Cosmetic Products NEC [Except Y-04, inks and permanent makeups]
- *** Denotes any selection available within the designated industry and class combination.
- Additional cosmetic products within industry code 53 that are not on the list above are not amenable for WEF processing.
- Additional industry codes used in cosmetic products will be evaluated on a case by case basis.
- CDER has determined that human drug products are not amenable for WEF processing.
- Drug Listing Number
- Application Number
- Registration Number
- Products will be evaluated on a case by case basis.
Medical Devices/In-vitro Diagnostic Products
- Registration Number
- Listing Number
- Below is a list of medical devices and their product codes identified as low risk and which may be amenable for WEF processing:
- Product Code: FML - Blood Donor Chair
- Product Code: FPF - Hot/Cold Water Bottle
- Product Code: FRI - Stand-on Patient Scale
- Product Code: FRJ - Geriatric Chair
- Product Code: FRK - Examination and Treatment Chair
- Product Code: ILI - Arm Sling
- Product Code: IPR - Crutches
- Product Code: ITJ - Mechanical Walker
- Product Code: KMN - Medical Chair and Table
- Product Code: KYR - Ice Bag
- Product Code: MDR - Therapeutic Medical Binder
- CDRH has determined that all other medical devices and in-vitro diagnostic 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.
- Product Code: RFU - Laser Fax Machine
- 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.
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.”
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.
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.
- For more information regarding Foreign-Trade Zones, please refer to the CBP manual.
- FTZ/WEF Spreadsheet to be used with a request for WEF processing
- Presentation on FDA & FTZs