Nutrition Business Journal interviewed Polsinelli Shughart attorney Jason Sapsin about the regulatory environment facing dietary supplements.
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About Jason Sapsin
Jason Sapsin is a member of Polsinelli Shughart's Life Sciences group, leading its FDA practice based in Denver, Colorado and is an instructor in regulatory affairs at Colorado State University's School of Biomedical Engineering. His clients include international food and medical device companies; clinical laboratories; pharmaceutical companies; biologics companies; dietary supplement companies; national health systems and clinical researchers. Mr. Sapsin assists companies and institutions bringing new medical products to market, including providing advice on the monitoring and regulation of sponsored clinical investigations and the duties of clinical investigators. Formerly Associate Chief Counsel in the Food and Drug Administration's Office of Chief Counsel, Washington, D.C., Mr. Sapsin advised FDA in investigations and in pursuing seizures, injunctions, product recalls and other enforcement action against drugs, dietary supplements and adulterated foods, negotiated with affected industry, provided technical assistance on pending legislation, assisted the agency in responding to civil litigation and GAO audits of FDA's domestic and international programs, and served as counsel to the Deputy Associate Commissioner for Regulatory Affairs in the Office of Regulatory Affairs (the enforcement arm of FDA). Mr. Sapsin has participated in several significant regulatory actions including the agency's promulgation of rules and guidance regarding fresh produce and nutritional labeling and FDA's expansion of cooperation between federal and state regulatory authorities in enforcement and regulatory actions. He has also advised FDA regarding the federal grants process.