With an education in chemical engineering and a prior career at the U.S. Food and Drug Administration, Seth brings clients rare regulatory insight on food, medical device and drug matters.
As Leader of the firm’s FDA group, Seth handles a broad array of matters involving FDA-regulated products and services including food, medical devices, pharmaceuticals, biotechnology, tobacco, radiation-emitting electronic products and cosmetics. He assists clients in premarket strategies, advises on postmarket compliance, handles enforcement matters – including those before the U.S. Department of Justice – and drafts and negotiates corporate transactions.
Seth began his career as a chemical engineer for more than a decade at the FDA, conducting regulatory research, performing inspections of regulated industry and serving as a compliance officer, followed by nearly 15 years in private practice. Clients appreciate his multidisciplinary experience when faced with highly technical regulatory issues.
Among other clients, Seth counsels food producers, importers, restaurants, trade groups, farms, and manufacturers of food packaging materials and food additives as well as manufacturers of medical devices and pharmaceuticals. FDA compliance issues such as GMP, FSMA, GRAS, LACF; California State matters including Proposition 65, CLRA, FAL and UCL; premarket submission for medical devices [510(k) and PMA] and drugs (NDA and ANDA) are just a few of the matters he assist clients with for optimal solutions. He also explores emerging markets, such as electronic nicotine delivery systems (ENDS) and industrial hemp and cannabidiol, identifying potential regulatory issues in order to guide clients in developing business and marketing strategies.
Food and Drug Law Institute (FDLI)