Former associate chief counsel in the U.S. Food & Drug Administration (FDA) Jason Sapsin has joined Faegre Baker Daniels as counsel in the firm’s food regulatory and litigation practice, health care and FDA practice, and national food and agriculture industry team. Sapsin will be resident in FaegreBD’s Denver office.
As counsel, Sapsin brings direct insight into FDA’s regulatory and investigation processes, which benefits clients introducing and defending food and life sciences products in the marketplace.
He helps drug, device and food clients manage risk, achieve product clearances and approvals, and navigate enforcement actions by analyzing and prosecuting IDEs, 510ks, PMAs, ANDAs, NDAs, monograph drugs, NDIs, Food Additive Petitions and GRAS notices during product investigation and development. He also helps clients comply with facility and product registration requirements, safety reports, user fees and safe manufacturing requirements. He develops and reviews advertising and marketing campaigns and labeling for foods, dietary supplements, cosmetics, drugs and medical devices; advises on and manages product recalls, import refusals and detentions; and defends against threatened FDA enforcement action.
“Jason's understanding of the complex federal laws and regulations directly affecting many of our clients will help us provide even greater insight, advocacy and practical legal solutions,” said Sarah Brew, partner and leader of FaegreBD's national food regulatory and litigation practice.
While at FDA, Sapsin advised the agency on investigations, seizures, injunctions, product recalls and other enforcement actions against drugs, dietary supplements and adulterated foods. He participated in significant regulatory actions such as FDA’s promulgation of rules and guidance regarding fresh produce, food safety, and nutritional and menu labeling. Finally, he was also involved with FDA’s initiatives to expand the scope of federal/state enforcement cooperation.
Sapsin’s diverse legal and public health background includes serving as assistant attorney general for the Maryland Attorney General’s office in the Maryland Department of Health and Mental Hygiene, the Maryland Health Care Commission and the Maryland Community Health Resources Commission, and serving as faculty at the John Hopkins Bloomberg School of Public Health.
“Jason’s deep knowledge about FDA regulations and public health issues makes him an excellent resource for the firm’s health care and FDA clients,” said Pat Cross, leader of FaegreBD’s national health and life sciences industry team.
Sapsin said, “I am delighted to have the opportunity to join Faegre Baker Daniels. The firm brings a unique combination of historical experience, incredible subject matter expertise and flexibility to addressing the challenges faced by clients of different sizes, operating in different FDA-regulated industries. Working with FaegreBD’s lawyers will put me in collaboration with incredible colleagues who approach the law with sophistication and practicality, both inside and outside the Washington beltway. It provides a fantastic opportunity to draw and expand upon my experience in food and drug law.”
Sapsin graduated from University of Michigan Law School cum laude and received his master’s in public health from Johns Hopkins University. He received his bachelor’s degree from Williams College, magna cum laude.