All products regulated by the FDA have to be submitted to a review FDA before being allowed into the United States. The FDA employs an electronic review process of all submissions for entry via the Customs and Border Protection Agency (CBP).

All products that are regulated by the FDA need to be compliant with the regulations and laws of the FDA on importation. It is up to the importer to ensure compliance with requirements to avoid refusal of admission.

How to Submit Entries of FDA Regulated Products

To begin any importation process, an importer needs to comply with the processes, requirements, and rules of the CBP.

It is always advisable for importers to work with a customs broker who can act as agents and entry filers. They can do this as they are authorized by US tariff laws to work as agents for importers seeking to transact with customs authorities.

Customs brokers are usually private firms or individuals that have been licensed by the CBP to prepare and submit the required customs documents, arrange for payments of fees and taxes and work to get the cargo in the custody of the CBP released on behalf of their clients.

The CBP website has a list of all the licensed and trained customs brokers in the US including the ports where they operate in.

Whenever an entry is submitted to the CBP, customs brokers or importers will usually have to include a Harmonized Tariff Schedule code in addition to other documents. Various HTS codes make it possible to determine if a given product requires FDA data before importation.

If there is any product with an HTS code that indicates that it is subject to FDA regulations, the importer or broker will need to submit information to the FDA. Information that will be required for electronic submissions include:

  1. Commodity and subtype
  2. Product description
  3. Product code
  4. Names and addresses of the importer, shipper manufacturer, and deliver-to-party. Importers can look up the FDA Establishment Identifier (FEI) based on names and addresses to validate the addresses of an FEI.
  5. Country code that identifies where a product is grown, sourced, produced, and harvested. 
  6. Contact information
  7. Value and quantity
  8. Estimated arrival time and date (this will usually not be transmitted to the CBP until about five days before the goods are to arrive at port).
  9. FDA Affirmation of Compliance (this could be mandatory in some cases)
  10. Certain products may be subjected to additional data submission elements (These products may be found in the FDA Supplemental Guide).

Some customs brokers/importers prefer not to use the electronic system and will usually have to submit their entry documents to the local FDA Import office, where they will be manually reviewed.

It is important to note that regardless of whether the submission is made through the manual or electronic processes, the FDA will still go through the information submitted with a fine-tooth comb to determine the admissibility of goods to be imported.

How the Harmonized Tariff Schedule Works

When a filing is made for products regulated by the FDA, importers or their entry filer/customs broker will have to include Harmonized Tariff Schedule codes in their filing. The HTS codes are usually tagged with an FD flag to help importers or brokers determine if they will require FDA data.

The following is a list of the FD flags and their meanings:

Flag

Meaning

Examples

FD1

Mayor may not be regulated by FDA: If regulated by FDA, submit entry information; if not regulated by FDA, disclaim

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

FD2

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

Medical Devices, Drugs, Tobacco, and Cosmetics

FD3

Mayor 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

The HTS otherwise referred to as HTS Code is one type of classification code that offers information and guidance on applicable statistical categories and tariff rates for all products imported into the US.

The Harmonized Tariff Schedule is based on the global classification system known as the International Harmonized System. The system classified and describes most commodities produced in the world. For importers looking for HTS codes, these can usually be found on the International Trade Commission HTS website.

How FDA Flags Work

The HTS code for most imported products is usually tagged with a specific FD flag. The flag usually indicates if an importer or customs broker needs to submit data and documentation to the FDA for review.

It is important to note that not all HTS codes are tagged with an FDA flag. Some products have HTS codes but are not subject to FDA regulation. Examples of these are textiles that are not required to have FDA flags. Nonetheless, this does not automatically mean that a given product is not FDA regulated as this may vary from product to product.

Given the variation, it is important to work with an entry filer/customs broker. Customs brokers usually know the intended use of a product which may determine if they may need to transmit data to the FDA even if the HTS code indicates that it does not have an FDA flag.

For FD1 or FD3 flags, the entry filer/customs broker needs to either disclaim the HTS code (using FDA disclaim code A) or submit a prior notice depending on the intended use of the imported product. FDA disclaim code F can be used in the case of entry type 21.

Why You Need to Contract a Customs Broker for Entry Submission

Customs brokers are important when an importer needs to process FDA-regulated goods. Some of the important services that they can provide include:

  1. Determination of the FDA regulatory status of imported products
  2. Electronic filing of Prior Notices
  3. Determination of appropriate Harmonized Tariff Schedule codes that have to be submitted to the CBP for all FDA regulated products
  4. Provision of the required or initial documentation to the FDA via the ITACS system or other electronic or manual means
  5. Provision of information to the importer regarding FDA-required information and related affirmations of compliance
  6. Submission of a product’s affirmation of compliance to the FDA. It is important to note that it is up to the importer to provide information such as registration numbers among other affirmation of compliance data to the customs broker for filing. 
  7. Obtaining a bond that will cover entry
  8. Transmission of mandatory FDA entry information using the electronic Automated Broker Interface at the CBP, which will then forward the information to the FDA. 
  9. Submission of required importation documents such as certifications, invoices, and government forms to the FDA. The importer will typically have to furnish the customs broker with the documents which they will then file with the FDA.
How to Expedite the FDA’s Review of an Entry

The most efficient way that the FDA can get a notification is via the ACE system. If submitting eCommerce products valued at less than $800, the entry will be submitted using Type 86. Most entries that are submitted to the electronic system are automatically screened against set criteria set by the FDA.

To ensure a fast review of an eCommerce entry, an importer or customs broker needs to submit complete and accurate information at the time of entry Type 86 creation. They also need to respond to requests for additional information and documentation promptly which helps move the process along faster.

Note that the submission of incomplete or inaccurate information and documentation may delay the review of the submission.

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