Mark Mansour is a Shareholder practicing in Butzel's Washington D.C. office. Mark is a member of the firm's Intellectual Property Practice Department and has practiced food and drug law for more than two decades.
He is highly experienced in securing FDA approvals for medical devices, managing medical device safety issues, managing recalls, market access issues, food and nutrition issues, dietary supplement regulation, agribusiness, and the regulation of cannabis products at the state and federal level. He is known among his clients for his innovative approach to issues, his responsiveness and his practical business advice.
Mark has long experience working with clients to resolve advertising issues involving the National Advertising Division (NAD) and the Federal Trade Commission. He has experience addressing social media regulation and has revised numerous corporate websites to ensure compliance with FTC requirements.
He has significant in house experience as counsel with two major multinational companies. He is well known for his innovative, business focused approach to problem solving as well as strong client relations skills.
Mark takes a holistic business oriented approach to client issues. He works with both attorneys and business units to ensure that objectives are clearly identified and met. He also assists clients and colleagues with FDA issues involving litigation and due diligence for corporate mergers and acquisitions, as well as with internal, civil and criminal investigations.
- Managing recalls and corporate crises
- Developing pathways for device approvals
- Applications for 510k and de novo approvals
- Compliance and enforcement advice
- Marketing advice
- Negotiating with FDA, including managing pre-submission meetings and follow-up
Food and Dietary Supplements
- Applications for health claims
- New dietary ingredient approvals
- Marketing, advertising and social media advice
- Negotiating enforcement actions with federal and state authorities
- Labeling advice
- Assistance with National Advertising Division (NAD) complaints and negotiating resolutions
- Working with FTC on consent decrees, negotiating resolutions and follow-up work with clients to revise websites and social media strategies
- Working with state consumer protection authorities to resolve consumer complaints lodged against clients
- Comments regarding proposed legislation and rulemaking
- Citizen Petitions
- Working with FDA to advance the business objectives of clients by making suggestions for future rulemaking
Primary Practice Areas
Georgetown University, JD
Harvard University, MA
Georgetown University, BS, cum laude, Phi Beta Kappa
- United States District Court for the District of Columbia
- United States District Court for the Eastern District of Michigan
- Washington, D.C.
- Food and Drug Law Institute
- ABA Regulatory Section
- DC Bar Regulatory Section
Awards & Recognitions
Awards & Recognitions
Washington, DC Super Lawyer
LMG Life Sciences Star
Alerts & Publications
- Client Alert, 2.23.2023
Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., United States District Court, Dist Massachusetts, 834 F. Supp. 2d 29 (D. Mass 2011)