FDA-REGULATED GOODS AND 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.
CPSC / PRODUCT SAFETY
Both federal and state laws impose specific product testing, certification, and recordkeeping requirements on a wide range of imported goods, from clothing to electronics. Goods that fail to comply with these standards can be seized, denied entry, 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 hazardous can damage a company’s finances and reputation.
DEPARTMENT OF TRANSPORTATION
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, program, and policies concerning supply chain security, occupational and transportation safety, and spoiled, lost, and damaged goods. Sandler, Travis & Rosenberg has substantial experience helping shippers, carriers, customs brokers, warehouses, freight forwarders, non-vessel-operating common carriers, third-party logistics providers, and others understand and comply with these provisions to avoid shipment delays and penalties.
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 by 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 of foreign-trade zone. Failure to comply with these requirements can result in seizure, forfeiture, or exclusion of the goods and revocation of an FWS-issued license.
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.
ST&R’s knowledgeable staff can help you identify and comply with all applicable state, federal, and foreign requirements to avoid shipment delays, penalties, and other problems.