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  1. Entry Process

Entry Submission Process

Products regulated by the FDA are subject to review by the FDA when they are offered for entry into the U.S. The FDA electronically reviews all FDA-regulated entries submitted through the U.S. Customs and Border Protection (CBP). FDA-regulated products imported into the U.S. must comply with all of the FDA's laws and regulations. The importer is responsible for making sure these products comply with all U.S. requirements. Products which do not comply with U.S. requirements at the time of importation are subject to refusal of admission.  Below you will find additional information about the submission process for FDA-regulated products.

How do I submit entries of FDA-regulated products?

The first step in any importation process begins with CBP. You must comply with CBP rules, requirements, and processes. Information about the importation process with CBP can be found at CBP’s website.

To import products into the U.S., you can contract the services of a customs broker (entry filer).  Customs brokers are the only persons authorized by the tariff laws of the U.S. to act as agents for importers in the transaction of their customs business. Customs brokers are private individuals or firms licensed by CBP to prepare and file the necessary customs entries, arrange for the payment of duties, take steps to effect the release of the goods in CBP custody, and otherwise represent their principals in customs matters.

CBP’s website has a clickable U.S. map that will provide a list of specific ports, and under each port, you will find a list of customs brokers. Customs brokers are trained and licensed to facilitate the importation of goods into the U.S. under applicable U.S. laws for importers. 

When entry is made with CBP, importers or their customs brokers (entry filer) will include the Harmonized Tariff Schedule (HTS) code among the other declarations in the entry. The HTS codes are flagged with indicators to help guide whether the FDA data is or is not required. The following table displays a list of the FD flags and some examples:

FD Flag

Is it regulated?

Example

FD1

May or may not be regulated by the FDA:  If regulated by the FDA, submit entry information; if not regulated by the FDA, disclaim

Certain chemicals used in manufacturing drug products vs. industrial use; safety goggles for medical use vs. non-medical use

FD2

Regulated by the FDA, but is not food:  Submit entry information 

Medical Devices, Drugs, Tobacco, and Cosmetics

FD3

May or may not be a food product:  If yes, submit Prior Notice (PN) and entry information; if no, disclaim 

Salt used for flavoring food vs salt used for treating road surfaces

FD4

Food product: Submit PN and entry information 

Fish and seafood, live food animals, dairy products, shell eggs, fruits, vegetables, food and feed ingredients, food and feed additives, infant formula, beverages (including alcoholic beverages and bottled water), bakery goods, snack foods, candy, canned foods, and dietary supplements and dietary ingredients.

When the HTS code indicates that the product is FDA-regulated, submission of information to the FDA is required:

  • Electronic submissions: 
    Customs brokers (entry filers) using the electronic system will be prompted to provide the following information for the FDA (in addition to the electronic information provided to CBP):
    • Commodity and subtype
    • Product code
    • Product description
    • Country code identifying where the product was produced, sourced, grown, or harvested
    • Names and addresses of manufacturer, shipper, importer, delivered to party. You can use the FEI portal to look up a FDA Establishment Identifier (FEI) based on a firm name and address or to validate an address of an FEI.
    • Contact information
    • Estimated arrival date and time (the entry will not be transmitted to the FDA for review until 5 days before the arrival date)
    • FDA Affirmation of Compliance (mandatory in some instances)
    • Quantity and value (voluntary submission)
    • Additional data elements may apply for certain products.  Refer to FDA's Supplemental Guide for further instruction.
  • Manual (paper) submissions:
    Importers/customs brokers (entry filers) who do not use the electronic system will be directed to provide their entry documentation to the local FDA Import office for review.

Regardless of whether the entry information is submitted to the FDA via the electronic system or via a manual process, the FDA will use the information available to determine the admissibility of the articles offered for import.

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What if there is no FD flag associated with my HTS code, but I believe the imported product is FDA-regulated?

Not all HTS codes have FD flags. This does not mean that the product is not FDA-regulated. Based on the intended use of the product, customer brokers (entry filers) are expected to transmit FDA data for HTS codes that do not have an FD flag.

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What can a customs broker (entry filer) assist you with during the entry submission process?

For information regarding the FDA's entry review process after your entry is submitted, please visit the entry review page.

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How can I expedite the FDA’s review of my entry?

The best way for the FDA to receive notification is through its electronic import entry review system.  Entries processed through this system will be electronically screened against criteria developed by the FDA.

Submitting accurate and complete information at the time of entry, and responding in a timely manner to requests for additional documents/information, helps expedite the entry review process.  Note: Submitting inaccurate or incomplete information may delay the review of your entry.

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