The U.S. market remains the world’s leading economy and the largest importer of goods. Foreign exporters (foreign food exporters, cosmetic exporters, exporters of housewares and food related products, medical device exporters, and exporters of drugs and biologics) look to the U.S. market for opportunities to significantly expand their business. In Fiscal Year 2022, total lines of products imported was about 51.24 million and imports continue to steadily increase. With our legal expertise and regulatory compliance services, U.S. importers have support in ensuring regulatory compliance, responding to enforcement issues, and finding new buyers and partners.
Foreign exporters seeking to export and sell FDA-regulated products to the U.S. market must ensure that products are compliant with U.S. laws and regulations. Exporters of foods, dietary supplements, cosmetics and personal care products, medical devices, Over-the-Counter (OTC) drugs, animal and veterinary products, beverage alcohol, and the product itself, are subject to inspection when offered for import into the U.S. FDA and/or CBP may refuse product entry if the products appear, from examination or otherwise, to violate FDA or other U.S. requirements. Foreign exporters are advised to identify product compliance requirements and ensure that all requirements are met prior to export to the U.S. This may include U.S. facility registration and product listing, certification and/or testing requirements due to prior history of violations. These requirements can be provided by regulation, or via enforcement tools, such as Import Alerts, or other international arrangements.
Compliance with foreign export and U.S. import requirements helps reduce import delays, including U.S. FDA, USDA, or CBP holds, examination or sampling. It also helps mitigate costs associated with testing, storage, shipment delays, frustration to U.S. importers (including Importers of Record) caused by unpredictable trade flow, and reputational damage. By complying with foreign export and U.S. import requirements, foreign exporters have a greater likelihood of fostering positive trade flow, a healthy relationship with regulatory agencies such as CBP and FDA, boosting consumer confidence and adding to their bottom line.