About Robert Durkin
Bob Durkin is a preeminent thought leader and subject matter authority in FDA regulation, helping health and wellness companies navigate their most intricate regulatory challenges.
With a rich background as a former Acting Director and Deputy Director of the Office of Dietary Supplement Programs (ODSP) in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), Bob brings a wealth of experience and unique insights to a diverse range of clients, particularly those operating within the dynamic and highly regulated dietary supplement and functional food industry sectors.
A strategic advisor for startups and Fortune 100 companies, Bob honed his approach through his 12-year career at FDA. His role involved policy analysis and evaluations across all aspects of the agency’s dietary supplement programs and spearheading innovative programs on compliance and enforcement issues, such as Warning Letters, seizures, injunctions, and import detention/refusal. He participated in various agency working groups, including the Agency-wide Marijuana Working Group, the Agency-wide CBD Policy Working Group, and the Agency-wide Investigational New Drug (IND) Policy Working Group. While at ODSP, Bob also successfully guided the Office through multiple GAO investigations.
Before his tenure at ODSP, Bob served as the Acting Director of CFSAN’s Food Defense Staff. In this role, he led a dedicated group of professionals responsible for determining the best regulatory strategies to protect our nation’s food supply from intentional contamination. The Food Defense staff’s work included the implantation of the Food Safety and Modernization Act’s Rule for Mitigation Strategies to Protect Food against Intentional Adulteration and determining the best ways to educate and regulate the industry relative to the Rule.
Bob’s diverse experience also includes serving in the Commissioner’s office and the Center for Drug Evaluation and Research (CDER). In the Commissioner’s Office, Bob managed a staff of Emergency Response Coordinators whose focus was coordinating an overall Agency approach to mitigate and respond to urgent health concerns related to FDA-regulated commodities. At CDER, Bob worked in the areas of health fraud, over-the-counter drugs, and pharmacy compounding.
