U.S. Customs and Border Protection enforces trade-related laws and regulations overseen by dozens of federal and state agencies, including those listed below. ST&R’s vast experience helping clients navigate these complex, interlocking requirements allow us to help you identify and understand those applicable to your business, develop and implement compliance plans and processes, and avoid shipment delays, penalties, and other problems.
FDA-Regulated Goods & FSMA Compliance
Foods, beverages, dietary supplements, drugs, cosmetics, and medical devices are regulated by the Food and Drug Administration. The Food Safety Modernization Act and other laws and regulations impose complex requirements for those who import, export, manufacture, and distribute these goods. FDA regulations cover issues such as product development, testing, and approval; classification; good manufacturing practices; labeling and advertising; registration of production facilities and U.S. agents; and supply chain security.
Savvy importers develop and implement plans to ensure compliance with these requirements to minimize the chances of costly enforcement actions that can include detentions, warning letters, inspections, product recalls, refusal of entry, and even liquidated damages claims. ST&R’s insightful attorneys and professionals can help your company understand and meet the applicable requirements and respond to any adverse developments quickly and effectively.
Both federal and state laws impose specific product testing, certification, and recordkeeping requirements on a wide range of imported goods, from clothing to electronics. Children’s products are subject to additional certification and testing prior to importation. Goods that fail to comply with these requirements can be detained, denied entry, seized, or destroyed, and importers, manufacturers, and distributors of such goods can be hit with substantial fines and penalties. In addition, recalls of goods found to be noncompliant can damage a company’s finances and reputation.
The movement of cargo into, out of, and within the U.S. is subject to domestic and international laws, including the Carriage of Goods by Sea Act and the Warsaw Convention, and associated regulatory requirements. Cargo transport may also be affected by laws, regulations, programs, and policies concerning supply chain security, occupational and transportation safety, and spoiled, lost, and damaged goods. Shippers, carriers, customs brokers, warehouses, freight forwarders, non-vessel-operating common carriers, third-party logistics providers, and others all need to be aware of these requirements.
Trade in most agricultural products is regulated by the Department of Agriculture, which oversees a number of laws and regulations that set forth specific requirements and restrictions on issues ranging from country of origin marking to organic certification. Agricultural product sales for domestic and international trade are accomplished via arrangements such as consignment agreements, fresh produce marketing agreements, grower’s agent agreements, and distribution agreements, which are subject to the Uniform Commercial Code and the United Nations Convention on the International Sale of Goods.
ST&R’s regulatory team assists clients in areas such as strategic business planning; product development, testing, and approval; product marketing, advertisement, and promotion; and regulatory compliance and enforcement, including government inspections and product recalls. ST&R is also experienced in handling agreements and disputes involving agricultural and food products, including regulatory issues, carrier claims, and other matters.
Fish & Wildlife
Import and export shipments of wildlife, including products made from wildlife or wildlife parts, require a license from the Fish & Wildlife Service, must be declared on a specific form, and generally have to be shipped through an FWS-designated port. In addition, export permits and re-export certificates are required for wildlife subject to trade restrictions under the Convention on International Trade in Endangered Species of Wild Fauna and Flora.
FWS requirements may apply to shipments that are not typically considered imports or exports by U.S. Customs and Border Protection, such as those placed in a bonded warehouse or a foreign-trade zone. Other agencies also exercise oversight of fish and wildlife shipments, including CBP, the Department of Agriculture, the Food and Drug Administration, and the National Marine Fisheries Service. In addition, individual U.S. states and foreign countries may impose their own specific requirements.
Imports and exports of pesticides, ozone-depleting substances, chemical substances, vehicles and engines, fuels, electronic waste, and other goods that could have a negative impact on the environment are subject to strict requirements enforced by the Environmental Protection Agency, including with respect to production, labeling, certification, notification, and recordkeeping.
U.S. law imposes requirements on ocean carriers, ocean freight forwarders, NVOCCs, and port operators to expedite imports and exports of containerized and breakbulk cargo. The Federal Maritime Commission enforces these laws, including by ensuring fair competition in ocean shipping and overseeing associated rates and charges. Importers, exporters, and shippers that believe violations have occurred can file complaints with the FMC to halt the offenses and possibly obtain reparations.