Mark Mansour

RELEVANT EXPERIENCE

Prior to joining Practus, Mark spent time as a Partner at major law firms including Mayer Brown, Jones Day and Akin Gump. Mark has extensive experience working with clients to resolve advertising issues involving the National Advertising Division (NAD) and the Federal Trade Commission (FTC). He is knowledgeable about social media regulation and has revised numerous corporate websites to ensure compliance with FTC requirements. He also assists clients and colleagues with FDA issues involving litigation and due diligence for corporate mergers and acquisitions and internal civil and criminal investigations. Mark has significant in-house experience as counsel with two major multinational companies. He is highly experienced in securing Food and Drug Administration (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.

REPRESENTATIVE MATTERS

Medical Devices

• 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

FTC regulation

• 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

Public Policy

• Comments regarding proposed legislation and rulemaking
• Citizen petitions
• Working with FDA to advance the business objectives of clients by making suggestions for future rulemaking

Government Relations and Public Policy

• Successfully secured Congressional intercession with FDA that led to a client’s application receiving approval after several years of delay
• Represented several companies in securing provisions in several farm bills
• Represented several companies in securing provisions in several authorizations of the Prescription Drugs User Fee Act
• Represented several companies in securing provisions in several authorizations of the Medical Devices User Fee Act
• Represents a foreign government involved in a dispute with FDA; successfully interceded with Congress to help secure a positive result
• Represented numerous companies in successfully securing assistance in disputes with government agencies, including FDA, FTC and the Department of Energy
• Represented medical device, pharmaceutical and food companies before the White House Office of Science and Technology, FDA, National Institutes of Health and both houses of Congress
• Represented food manufacturers before the governments of the United Kingdom, the European Commission and member states and international standard setting bodies; successfully secured favorable standards and regulations and assisted in defeating adverse regulations