New importers often ask, “what exactly are the steps needed to start importing FDA-regulated products”? Of course, the “steps” vary depending on the types of products you are importing, the country of origin, how the products are intended to be used, and many other factors. However, the basic steps for importing most products include:

Know what government agencies regulate your product.

More than one federal agency may have jurisdiction over your products. For example, FDA and USDA regulate different food products and their jurisdictions overlap in some areas as well. Your Customs broker can assist you in determining what federal agencies regulate your products. Also, foods must comply with state government regulations as well. You should know all of these requirements well in advance of importing the goods, so you have sufficient time to take any necessary actions to avoid any holds, detentions, refusals, seizures, of other problems with the clearance of your merchandise.

Find a freight forwarder.

The products’ shippers often hire the freight forwarders, but sometimes the importer does this. While some companies offer both freight forwarding and Customs broker services, these are separate operations. The freight forwarder arranges the shipment of the goods from the shipper to destination. They provide the broker the required entry documentation such as the bill of lading, commercial invoice, packing list, etc. The freight forwarder may also be the carrier (the vessel that carries the goods) or may work with a separate carrier company to deliver the goods. The freight forwarder also may arrange the storage of the goods when they make entry.

Hire a broker licensed by US Customs to file your entries.

Although you can file your own shipments (“entries”) the filing process can be very complex so for commercial shipments, most companies hire a US Customs-licensed broker to file their entries. The broker files the appropriate entry documentation with Customs and all other pertinent US federal agencies such as FDA, USDA etc. The broker determines the correct duty rates, taxes, and fees for importing the goods and pays Customs any fees required for clearance. We highly recommend hiring a broker with a lot of experience dealing with FDA-regulated products because these products are subject to a lot of unique rules and procedures. The freight forwarders sometimes provide their own Customs filing services or work with specific brokers.  Sometimes importers hire their own Customs brokers. If you need assistance in finding a broker, FDA Specialist can refer the right broker for you based on the type of product you are importing and other factors.

Determine which mode of transportation is best suited for your shipments.

Considerations for the type of transportation you use to move your goods should be based on the nature of the goods, the size of the shipments, commercial value of the shipments, perishability/expiration dates, and other factors. For example, if you are shipping a product with a very short shelf-life in small quantities, you may consider shipping by air rather than by ocean freight. However, for larger shipments that do not have a short shelf life e.g. are not perishable, it may be significantly less expensive to transport by ocean vessel. When comparing costs of the different modes of transportation, be sure to factor in costs of insurance, Customs filing, freight forwarding, and inland transport in the country of origin and transport costs of moving the freight from the port of arrival to destination.

Decide where your goods will be stored when they arrive at the port of entry.

You can store the goods at your own warehouse or use a commercial third-party storage facility. Some importers rent or borrow space from other importers’ warehouses which may save on storage costs. The storages facility must meet requirements of the FDA and all other applicable government agencies such as the state and county governments agencies. The facility may be subject to FDA’s registration requirements as well.  

Obtain an Import Bond

The Importer of Record is the entity responsible for ensuring that goods are imported in accordance with all federal laws and regulations. The Importer or Record is required to obtain an import bond for most shipments with a commercial value of $2500.00 USD or more. The bond helps ensure that Customs will be paid the appropriate duties, any penalty fees, and any other required fees. The Importer of Record is often the company that is importing the merchandise but may be a third party such as a Customs broker. The Customs brokers typically arrange the bond.

Of course, the above list is not exhaustive. In addition, each type of commodity is subject to different regulatory requirements. For specific information related to each type of commodity, please click on the corresponding link below:

• Foods (Including Dietary Supplements)
• Cosmetics
• Drugs
• Medical Devices

FDA also regulates foods for animal use, veterinary drugs, food contact surfaces, biologics, and radiation-emitting devices. FDA Specialist will provide more information on this website for these commodities soon!