Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Import Basics

Import Basics

                        FDA’s Administrative Destruction Authority
          Overview of the SUPPORT Act Provisions Related to Imports
          Common Entry Types
          Foreign Trade Zones/Weekly Entry Filing
          International Mail Facilities
          Personal Importation
          Import for Export
          Harmonized Tariff Schedule and FD Flags


                        Import Systems Home
          For Industry
          Import Program – Food and Drug Administration (FDA)
          Import Basics
          Foreign Trade Zones/Weekly Entry FilingImport Basics Foreign Trade Zones/Weekly Entry Filing
  
  	
    Share
    Post
    Linkedin

    Email
    Print**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?Back to top



**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.

Back to top

**Where are FTZs currently located?**

FTZs are located in all 50 states and Puerto Rico.  Visit Trade.govfor a list of zones by state.

Back to top

**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.

Back to top

**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.Back to top

**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 the FDA Import Division Office covering the intended port of entry. Find an FDA Import office near you.

Back to top

**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:

			Manufacturer
				For products manufactured in an FTZ, report the manufacturer in the FTZ;
					For products manufactured in a foreign country and only stored in the FTZ, report the foreign manufacturer.
				Foreign Shipper:
				For products manufactured in an FTZ, the foreign shipper is not needed for the submission of the WEF request;
					For products manufactured in a foreign country and only stored in the FTZ, report the foreign shipper that shipped the product to the FTZ.
				Importer of RecordNote:  The manufacturer's registration number is required, when applicable.**Product Information**
			Commercial product name;
				Product description;
				FDA product codeof the articles being withdrawn from the FTZ**Below is the commodity specific information:**

**Commodity**
			**Additional Information** ***Human Food**
			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:
				**29B*** - Carbonated Soft Drink**
					**29S*** - Carbonated Water**
					**32A*** - Malt Beverage**
					**32B*** - Wine**
					**32C*** - Liquor**
					**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.**Tobacco Products**
			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.**Cosmetics**
			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.**Human Drugs**
			CDER has determined that human drug products are not amenable for WEF processing.**Animal Drugs**
			CVM has determined that animal drug products are not amenable for WEF processing.**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.
				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.**

Back to top

**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.

Back to top

**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.

Back to top

**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.

Back to top

**Additional Information:**

For more information regarding FTZs, please refer to the CBP manual.
	FDA WEF Product List Spreadsheet
	Presentation on FDA & FTZsBack to top

                                                                                  Content current as of:
      03/03/2022Import Basics

          
                        FDA’s Administrative Destruction Authority
          Overview of the SUPPORT Act Provisions Related to Imports
          Common Entry Types
          Foreign Trade Zones/Weekly Entry Filing
          International Mail Facilities
          Personal Importation
          Import for Export
          Harmonized Tariff Schedule and FD Flags


                        Import Systems
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop