Jason W. Sapsin, JD, MPH
Faegre Baker Daniels LLP (Boulder, CO)
Jason Sapsin is an attorney in Faegre Baker Daniels’ food regulatory and litigation practice, health care and FDA practice, and national food and agriculture industry team. As a former associate chief counsel to the U.S. Food & Drug Administration, he brings direct insight into FDA’s regulatory and investigation processes, which benefits clients introducing and defending food and life sciences products in the marketplace. Jason helps drug, device and food clients manage risk, achieve product clearances and approvals, and navigate enforcement actions. His work includes: analyzing and prosecuting IDEs, 510ks, PMAs, ANDAs, NDAs, monograph drugs, NDIs, Food Additive Petitions and GRAS notices during product investigation and development, helping clients comply with facility and product registration requirements, safety reports, user fees and safe manufacturing requirements, developing and reviewing advertising and marketing campaigns and labeling for foods, dietary supplements, cosmetics, drugs and medical devices, advising on and managing product recalls, import refusals and detentions, defending against threatened FDA enforcement action. Jason has counseled clients ranging from multibillion-dollar corporations to small startups on products such as food, medical devices, pharmaceuticals, biologics, dietary supplement and veterinary products. He also advises health systems, clinical researchers, research organizations and laboratories.