Global Exporters
Business clients
Compliance with foreign export and U.S. import
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.
★★★★★
Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.