Importing food into the United States can be a complex process, particularly when it comes to complying with regulations. One key regulatory agency that importers need to be aware of is the Food and Drug Administration (FDA). The FDA is responsible for regulating the safety of most imported foods that are sold in the United States, and it has several programs in place to ensure that imported foods meet the same safety standards as domestically produced foods. In this blog, we'll provide an overview of the FDA's role in regulating imported food and some key considerations for importers.
Food Import Regulations: Importers of food products are responsible for ensuring that their goods meet all required import regulations, including those set by the FDA, USDA, CBP, and FWS. Additional regulations may apply for specific food products such as milk, meat, honey, and more. Import documentation required for all food products is discussed below.
Prior Notice: One of the most critical aspects of importing food is filing Prior Notice with the FDA. This is an electronic submission made through either CBP or FDA’s electronic interface system, which allows FDA and CBP officials to prioritize inspections for upcoming food imports scheduled to arrive in the U.S. Information required when submitting Prior Notice includes but is not limited to: the country of production, anticipated arrival details, shipper's information, carrier and method of transportation, and FDA Product Code. The timeframe for submitting Prior Notice will vary depending on the mode of transportation and whether you use CBP or FDA’s electronic interface system. Failure to submit Prior Notice or submitting incorrect information can result in penalties, seizure, and destruction of goods, or a ban on future imports.
ISF Filing: If your food products are arriving to the United States by vessel, an ISF Filing is required. Failure to comply with the rule could ultimately result in monetary penalties, increased inspections, and delay of cargo.
FDA Facility Registration: Ensuring that your foreign partners are registered with the FDA is a crucial step in successfully clearing imported food. As per regulations outlined in the FDA’s Foreign Supplier Verification Program (FSVP), nearly all foreign manufacturers, suppliers, and distributors of food intended for import to the U.S. must register their facility with the FDA.
The FSVP requires importers to keep records that demonstrate that foreign suppliers are adhering to all FDA requirements, allowing the FDA to verify that proper handling, processing, and storage procedures are being followed. To streamline the food import process, it is recommended to include facility registration information at the time of import, along with all other required documents, to avoid delays caused by import agents having to verify the information themselves. Importers are also required to have plans in place to ensure that the food they import continues to meet these standards during transportation and storage.
It's important to note that the FDA has the authority to detain or refuse entry to imported foods that do not meet U.S. food safety standards. If an imported food is found to be unsafe, the FDA can issue a recall to remove it from the market. This is why it's so important for importers to be diligent in ensuring that their imported food meets all applicable regulations.
Bill of Lading: A Bill of Lading (BOL) is a crucial document in the import and shipping process. It serves several purposes, including acting as a title for the goods being transferred from the shipper to the receiver, providing a contract of carriage between the carrier and the shipper, acting as a receipt for the delivery of the goods upon completion, and giving tracking information so that involved parties can follow the status of the shipment. For customs, the BOL allows CBP agents to verify shipping details against other included documents and investigate any inconsistencies or concerns to determine if any importing rules have been violated. The BOL is typically created by the shipper or a freight forwarder on their behalf.
Commercial Invoice: A commercial invoice is a document that provides detailed information about the sale of the goods being shipped. It must include information such as the country of origin of the goods, the date of the sale, the purchase price of each item, the currency and payment method used, the total value of the transaction, HTS Code, and more. This information is used by CBP agents to calculate and verify import duties, and incorrect information can lead to higher import duties or increased inspection times.
Packing List: A packing list is a document that provides a detailed inventory of the dimensions and quantities of products included in a shipment. Despite containing similar information to a commercial invoice, it is important to include a packing list when importing food. The packing list includes the number of packages in the shipment, the specific dimensions of each package, the quantity and description of goods within each package, the total weight of all packages, and invoice numbers that match those on the commercial invoice. This document, along with others, can be submitted electronically to CBP to clear and release your goods.
Customs Bond: A customs bond is a financial guarantee that is required for all commercial shipments arriving in the U.S. It is necessary to have a bond in place to ensure that all import duties and fees are paid to CBP. There are two primary types of import bonds that are commonly used for standard import situations, continuous bonds and single-entry bonds. If you require a customs bond, please reach out to MRB International Customs Brokerage for pricing options.
Entry Summary: The final document required for the clearance of your imported food is the entry summary, also known as CBP Form 7501. This form serves as a comprehensive summary of all crucial information pertaining to your import, including but not limited to the entry type, estimated duties and taxes to be paid, and bond type. It is important to note that while this form may seem repetitive as it includes information previously listed in other documents, it is necessary for CBP to cross-reference these details to ensure the safety and legality of imported goods. If you are new to importing, it may be beneficial to work with a Licensed Customs Broker who can assist with the submission of this form and simplify the process for you.
Food Labeling Requirements: If you plan to import food products into the U.S. for resale, it is important to be aware of and comply with FDA, USDA, and CBP food labeling requirements. These requirements vary depending on the type of food product, but some guidelines apply to all food products. Here are a few key labeling requirements for imported food products:
Country of Origin: The country of origin must be clearly indicated on the label for all imported food products. This can be done by including "Product of [country]" on the label.
Foreign Language: If any foreign language is present on the label, there must also be an English translation provided.
Name and Address: The full name and address of the company distributing the food product must be listed on the label. If the company listed is not the manufacturer of the food, accompanying text stating "manufactured for..." or "distributed by..." must be included.
Brand Logo: Labels that contain the logo and/or name of a U.S. company must be used with permission in terms of copyright laws. Importers must be able to provide proof of copyright permission if requested by CBP.
It is important to note that these are just a few of the many food labeling requirements for packaged foods. In some cases, certain labeling requirements may be exempt for small businesses, certain foods with little to no nutritional value, and medical foods. Before ordering pre-packaged food from a foreign supplier, be sure to verify that the labels are compliant with FDA requirements. Additionally, some food products such as organic foods, may require specific labels.
Understand the Incoterms for Your Imported Food: Understanding the Incoterms for your imported food is crucial for managing the logistics and financial aspects of your shipment. Incoterms, or International Commercial Terms, are a set of 11 standardized terms that outline the responsibilities of both the buyer and seller in an international commercial shipment. Each Incoterm is represented by a unique 3-letter abbreviation. It is important to note that Incoterms also determine the responsibilities for customs clearance. For example, an Incoterm such as DDP (Delivered Duty Paid) places most of the responsibility and risk on the seller, including paying for import duties and filing import paperwork, while an Incoterm such as EXW (Ex Works) places most of the responsibility and logistics costs on the buyer, including export customs clearance. Before agreeing to an international shipment, it is important to fully understand the Incoterms that will be used to avoid any unexpected expenses or surprises in the import process. Working with a Licensed Customs Broker can help you understand the specific responsibilities and costs associated with each Incoterm and ensure a smooth import process. Please see our blog on Incoterms below.
In conclusion, navigating FDA regulations for importing food into the United States can be a challenging process, but it is critical for ensuring the safety of the food that we consume. By working with a customs broker and being diligent in complying with all applicable regulations, importers can help ensure that the food they bring into the country meets the necessary standards.
Contact MRB International Customs Brokerage today if you need assistance with FDA importations. info@mrbint.com 704-285-2925
*Disclaimer
This information has been provided as a resource to familiarize U.S. Importers and Exporters with FDA regulations. This post is not legal advice, and the information provided is not the official legal or full definition of each other government agency regulations. When pursuing a specific import/export transaction, you are encouraged to conduct your own due diligence and to consult legal counsel as appropriate.
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