The Food and Drug Administration (FDA) keeps some pretty tight rules on various products that come into the country. Following the protocols prescribed by the FDA is imperative to making sure that your imports reach the country without incident. To accomplish this, it’s important to understand what the FDA entry process is and how HTS Codes with FD flags are assigned to products.
The entry process begins when products assigned with HTS codes make entry with the Customs and Border Protection (CBP). Once there, the FDA will give one of four FD flags to the HTS codes if your products are for human or animal use, such as food, veterinary items. Each FD flag indicates what the product is and if the FDA needs more information.
The FDA has numerous guidelines for importing products that they regulate. Our guide below highlights all of the important information you need to know.
The HTS Code helps to ensure that the proper tariff rate for your product is applied to it. HTS codes not only determine the appropriate tariff for your import but also give a statistical category of the product itself.
HTS Codes are derived from the International Harmonized System (HS). The HS serves the same purpose except it works on a global scale to describe almost all of the world’s commodities. Once an import has its HTS Code it will be assigned an FDA flag.
Since the HTS Code can vary depending on the product that is imported, so will the duty rate on every product. Ensuring you have the correct HTS code for your imported product(s) is often one of the most challenging tasks when it comes to importing. This is especially true for new importers that aren’t familiar with the process.
After you or your customs broker identifies the correct HTS Code for your import, the code might be flagged by the FDA. This flagging system used by the FDA helps them conduct reviews to ensure regulated goods are in compliance with their regulations.
FD flags can indicate what product is being imported and if the FDA requires more information regarding the product. The FD flags are as follows:
FD1 flags are products that may or may not be regulated by the FDA. If the product is something that is regulated by the FDA then you should submit the relevant information to them. Some products that are regulated by the FDA might share similar names with products that are not regulated. Products that would fall under FDA regulation and receive an FD1 flag are:
Products not regulated that share similar names to these are:
Even for products that receive an FD1 flag and are not regulated by the FDA, additional work must be done. The importer or their customs broker must provide sufficient evidence at the time of import that proves the products aren’t intended for medical use.
Given its name, the FDA doesn’t regulate only food. The FD2 flag is used to indicate products that are regulated by the FDA but do not fall under the food category. Such products include:
Importers are required to submit appropriate entry information for these goods.
FD3 flags are used to determine if a product is food or not. Similar to the FD1 flag, some regulated food products share names of non - food regulated items. Products that are food include:
A product that is not food would be:
Again, just like FD1 flagged products, importers will need to submit documentation for either type. The documentation will either prove compliance with FDA standards or support that fact the intended use is not for food consumption.
The last type of flag that will be found with an HTS Code is the FD4 flag. HTS codes that have an FD4 flag attached to them are food products that are regulated by the FDA. Some food products that are regulated by the FDA are:
Products that have HTS codes with an FD4 flag must submit required entry information. Additionally, Prior Notice (PN) must be filed with the FDA before the products arrive.
So you might be asking yourself “do all HTS Codes have FD flags?” The answer to that question is no. The FDA does not use FD flags on all imported products.
For example, textile imports would not have FD flags attached to them. That said, just because an imported product doesn't receive an FD flag doesn't mean that the FDA doesn’t regulate that product.
What determines if an import is given an FD flag or not is how that product is intended to be used. The FDA describes intended use as the intent of the persons that have legal responsibility for labeling the product.
Products like food or medical devices are intended to be used by people. Since the FDA’s purpose is to protect the public health of Americans, items meant for human use or consumption would fall under their regulations. Even animal and veterinary items would fall under their jurisdiction as well.
If you’re unsure if your imported products are subject to FDA regulation, a Licensed Customs Broker can help you. A reliable customs broker can identify the intended use of your import based on some key factors. Based on that knowledge, your customs broker will know if they have to submit more information to the FDA even if your products’ HTS Code doesn’t receive an FDA flag.
Countless products are imported into the U.S. and knowing which ones fall under FDA regulations can be difficult to discern. To make it easier below is a broad list of items that the FDA does regulate:
How you register your product with the FDA all depends on the product itself.
To learn more about the import process for FDA-regulated goods, check out our complete guide on FDA Customs Clearance.
If you want to import FDA-Regulated products into the US there are other steps that you should know besides the entry process. The other steps you have to take go like this:
FDA entry numbers are an important piece of information that the FDA uses to track and locate your shipment. The entry number will have a total of 11 characters. The first three characters of the entry number will contain numbers and letters. These three characters are your customs broker filer code. The following seven digits represent the transaction code that was assigned by the entry filer. The last digit is a check digit.
As an importer time is of the essence, especially if you are importing products for commercial use. That is why it's important to make sure that the entry number is submitted as soon as the FDA requests for it. Not only will submitting the entry number help your import get to where it needs to be on time, but it might allow your shipment to be expedited.
The FDA will use the entry number for other reasons besides tracking and locating your shipment. Another use for the tracking number is that it allows the FDA to review or gather further information regarding your shipment. They can then use the information the entry number reveals and compare that to information included in the product invoice.
Information attached to the entry number can also be compared to any other import information about your product. Attaching an entry number allows the FDA to determine that the information regarding the product is accurate.
If you haven't already noticed, a customs broker/entry filer is a vital asset to have if you are importing FDA-regulated products. We have already discussed how customs brokers can determine what products are FDA regulated and how customs brokers are licensed by the CBP.
Another way a customs broker can help you import FDA-regulated products is by making the process easier for you all together. All the responsibilities that come with importing FDA-regulated products like filing entry paperwork and arranging necessary payments for duties can all be taken care of by a customs broker.
If you are importing an FDA-regulated product for personal use you probably don’t have all the knowledge of the rules and regulations the FDA keeps. Or if you are importing products for commercial use you probably have other aspects of your business to worry about. Either way, a customs broker can relieve you of these stresses by taking care of them for you.
When the HTS code of your imported product indicates that it’s regulated by the FDA then you will be required to submit further information on that product. This is another responsibility that a customs broker can take care of. Other forms of information that a customs broker can submit to the FDA on your behalf are:
All of this information can be submitted by your customs broker electronically or manually on documentation provided by the FDA. The documentation must be submitted to a local FDA Import Office.
There are many other ways that a customs broker can help you with the importation of FDA-regulated products. Among them are:
There is a good amount of information that is required by the FDA when you import a product that is regulated by them. Rather than taking the time to know all of that information, compiling the information, and submitting it to the FDA at the appropriate time, let a customs broker take over the responsibility.
At USA Customs Clearance, we have an expert team of Customs Brokers that will make sure your FDA regulated imports meet their specifications.
At USA Customs Clearance, we can keep track of all FDA regulations for you. Whether you import for commercial use or personal use, your time is valuable. With our over 100 years of combined experience in importing, you can count on us to take care of all import needs.
Our experts at USA Customs Clearance know all the regulations outlined by the FDA and any other government agency involved in the importing process. We can ensure that your imports will be imported into the country hassle-free.
If there is anything that you are unclear on you can always find your way to our consulting page where you can schedule a consulting session. One of our Licensed Customs Brokers will be able help you out with whatever you need. We’ll examine your import situation and guide you on the next steps that you should take.
Not sure if you’re ready to consult with our experts? No problem. Contact our team and they’ll determine the best course of action for you.