Imports
Importing Basics
Importing begins with US Customs and Border Patrol (CBP or Customs), where all products entering the US must be declared. Part of CBP’s responsibility is to guide importers to increase compliance with laws and regulations. CBP works alongside other federal agencies like the Food and Drug Administration (FDA), US Department of Agriculture (USDA), Environmental Protection Agency (EPA), US Fish and Wildlife Service (USFWS), Consumer Product Safety Commission (CPSC), Drug Enforcement Administration (DEA), and Alcohol and Tobacco Tax and Trade Bureau (TTB) to regulatory compliance when importing goods into the US.
All imported products must meet the same standards as domestic goods. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe and made from approved ingredients; radiation-emitting devices must meet established standards; and all products must contain informative and truthful labeling in English. In addition, all products must conform to complex laws and regulations relating to their labeling.
Requirements & Registration
There are many requirements for importing product into the US. USDA requires that meat, poultry or egg products must originate from certified countries and establishments eligible to export to the United States. They become eligible following an equivalence determination process by the Food Safety and Inspection Service (FSIS). The Animal and Plant Health Inspection Services (APHIS) restricts some products from entering the United States because of animal disease conditions in the country of origin.
Certain special US import declaration requirements apply to imported foods (including conventional foods, beverages, dietary supplements, and ingredients), drugs, and medical devices. For example, food importers must submit a Prior Notice to FDA, including information about the product, its manufacturer, and its importer. Other specialized FDA import declarations apply to canned foods and beverages, drugs, and medical devices. Failure to submit before the imported food arrives in the US can result in detention.
While CBP does not require licensing before importing, some other agencies do. For example, USDA uses import licensing to administer the tariff-rate quota (TRQ) system for US imports of dairy products. A license from the Foreign Agriculture Service (FAS) is generally required to receive the lowest tariff rate. Companies wishing to import FDA-regulated products may need to file under the Bioterrorism Act, submit an Affirmation of Compliance (AofC) to affirm product compliance, establish a product code with FDA, register facilities and products manufactured in them, and more.
FDA has the authority to examine imported shipments to verify their compliance, with no time restrictions. Based on an examination or any other evidence, FDA can examine a shipment and choose to detain it.
The Customs Entry
The import process begins with the importer or customs broker submitting the necessary Customs entry details electronically. Customs forwards the data to FDA for its review. When FDA requires additional documentation, it makes the request to the customs broker. It is not uncommon for FDA to ask for information or documents from the foreign shipper or foreign manufacturer to verify compliance with FDA requirements.
Entry declarations and information must clearly identify the product by Customs Harmonized Tariff Schedule codes according to the Harmonized Tariff Schedule of the U.S. (HTSUS), and FDA product codes, which are different from the HTSUS codes. Most customs brokers can and will assist with classifying imported products according to the HTSUS; however, many require their importing clients to provide the FDA product codes. Improper classification can result in an improper payment of Customs duties, which can result in penalties. The Customs entry and FDA declarations must include information about the product, the country of origin, the foreign manufacturer and the foreign shipper, the importer of record, the consignee, the quantity and value of the imported goods, and an appropriate description. All these declarations are subject to specific regulations issued by Customs, primarily, as well as FDA. The FDCA also requires that the registration numbers of foreign food establishments and foreign drug and medical device establishments be included in entry-related filings (in the Prior Notice submission for food imports and in a statement provided to FDA for device and drug imports). For canned foods, FDA recommends (but does not require) submission of the foreign manufacturer’s food canning establishment (FCE) number, and the scheduled process identification (SID) number.
Virtually all imported foods are subject to FDA’s Prior Notice requirements under the Bioterrorism Act (BTA). In most cases the FDA Prior Notice is transmitted at the same time the Customs entry is filed by the customs broker using the same filing process and electronic system. However, importers and foreign exporters may separately file the FDA Prior Notice using an FDA electronic system as well.
All FDA-regulated products have their own unique compliance affirmation codes relevant to the import clearance process. FDA may issue detentions for Customs entries based upon the failure to provide such information electronically. In instances where the FDCA or FDA regulation requires submission of the data at Customs entry, such detentions are lawful. However, where no statute or regulation requires submission of data at entry (e.g., submission of an FCE or SID number, submission of drug or medical device listing numbers, and other numerical identifiers not covered by statute or regulation), this kind of detention, based solely upon failure to submit the data at Customs entry and where the only evidence FDA has regarding the shipment is the alleged failure to submit the data, is unlawful.
Customs Conditional Release
Ordinarily, once the Customs entry information and a Customs basic importation (or other) bond is filed covering the imported goods, Customs will release the imported product to the importer’s custody even while FDA is still deciding whether the product may be admitted entry to commerce for distribution. This Customs release prior to issuance of an FDA release is called a Customs conditional release. Read more about US Customs.
Import Manuals
Customs regulations, the Bioterrorism Act (BTA) and FDA regulations impose certain important record keeping requirements on importers, owners and consignees of imported products. These records may apply to the importation, distribution, storage, further processing or transportation of the products. Failure to maintain the required records for the required periods of time established by federal regulations can result in administrative, civil and even criminal enforcement actions (although criminal cases are rare for such violations unless the person intended to defraud the government or third parties and failing to maintain the records was a part of the fraud).
Import Standard Operating Procedures (SOPs) help firms identify what records to maintain. These import SOPs or import manuals also help the importer’s employees and agents (such as customs brokers and freight forwarders) know which company employee is responsible for specific required tasks. Import SOPs also help the importer document that it is in compliance with federal requirements. One of the most important benefits obtained from a complete set of importing procedures; however, is assisting the company in ascertaining what information should be provided to which agency and when and how to provide answers and solutions to likely and foreseeable importation delays, investigations, and inquiries of Customs and FDA inspectors and compliance officers. Read more about SOPs.
Detention, Refusal, and Redelivery
Whenever an importer must respond to an FDA import detention, a Customs hold or a U.S. Department of Agriculture manifest hold or Emergency Action Notification, detailed legal and regulatory knowledge of the respective federal agency’s scope and requirements is necessary to identify and provide — in the proper format and venue — the specific information the agency is seeking.
If FDA finds a problem with a shipment, it will detain it. During detention FDA does not take control of the shipment. CBP typically releases it on a bond, and failure to comply with importer obligations leads to financial penalties of up to three times the value of the product. During this detainment period, the importer can submit testimony to prove the compliance of the shipment. If FDA was not in error, it can then rule whether to refuse the shipment, or allow for reconditioning. Reconditioning can happen if the product has a problem which can be resolved in this shipment, such as the relabeling or irradiating of products, but reconditioning must occur before refusal. If the shipment is refused, it must either leave the country or undergo supervised destruction (which is subject to local and environmental regulations) within 90 days. Read more about detentions.
Need Help?
FDAImports assists foreign manufacturers and U.S. importers with obtaining required permits, certifications, licenses, and approvals as well as ensuring products are properly labeled prior to importing their products. Ensuring compliance with U.S. requirements is critical to obtaining and maintaining market share in the U.S. We make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond.