M. Mark Mansour Member

Areas of Practice

Industries

Bar Admissions

  • District of Columbia
  • Michigan

Education

Georgetown University Law Center, J.D.

Harvard University, M.A.

  • International Relations and Affairs

Georgetown University Walsh School of Foreign Service, B.S.

  • International Relations and Affairs

Mark Mansour is a Member in Dykema's Washington, D.C. office. Mr. Mansour has practiced food and drug law for more than two decades, securing FDA approvals for drugs and devices, reviewing drug and device advertising materials, responding to drug, device and food safety issues, and managing recalls. He counsels U.S. and multinational clients on market access, food and nutrition policy, biotechnology, nanotechnology, dietary supplement regulation, agribusiness, and the regulation of cannabis products at the state and federal levels. 

Mr. Mansour has long experience working with clients to resolve advertising matters involving the National Advertising Division of the Council of Better Business Bureaus and the Federal Trade Commission (FTC). He advises clients on social media regulation and has revised numerous corporate websites to ensure compliance with FTC requirements.

He is a member of the ABA Life Sciences Committee and the D.C. Bar regulatory committee, where he has participated in numerous events, discussing issues involving medical devices, pharmaceuticals and biotech. In addition, Mr. Mansour has given numerous speeches, webinars and written materials for the Food and Drug Law Institute (FDLI), which is the pre-eminent organization representing the food, drug and device bar. 

Mr. Mansour previously served as in-house counsel with two major multinational food companies. He is known for his innovative, practical approaches to problem solving, as well as his strong client relations skills. He received his BS from Georgetown University, an MA from Harvard University, and his law degree from Georgetown University. He is admitted to practice law in the District of Columbia and Michigan. 

Select FDA Representative Experience

General

  • Premarket applications: assisted in preparing and reviewing ANDAs for review at the FDA

Food and Dietary Supplements

  • Regularly advise on regulatory issues related to M&A deals in the food industry
  • Drafted and filed citizen petition requesting that the FDA allow food companies to label potassium chloride by its alternative common and usual name potassium salt
  • Advised ingredient manufacturer and global foodservice operator concerning regulatory requirements for providing certain ingredient/dietary warnings to patrons
  • Provided regulatory counseling concerning labeling and claims, such as those related to proper ingredient labeling and use of terms, including natural, organic, non-GMO, •Made in• (a particular location) and the like
  • Worked with the FDA, USDA, U.S. Pharmacopeia (USP) concerning ingredient labeling and other compliance issues
  • Drafted/submitted petitions and comment letters to the FDA/USDA concerning Interim final rules, draft guidance and petitions submitted by other food Industry members
  • Provide counseling concerning all manner of Issues related to product defects, including working with government and business partners to determine whether and how to conduct market withdrawals or recalls or how to safely repurpose product, if possible
  • Advise on FDA regulations for pesticides for imported produce
  • Advise on responses to cGMP violations for vitamins and nutraceuticals
  • Advise on cGMP compliance for food manufacturing and processing plants for com and wheat products
  • Managed many of the major national food recalls for one or more affected clients for the past two decades, including melamine in human and pet food, peanut butter, food allergens, lettuce, peppers, tomatoes, meat, poultry and numerous other pathogens, adulterants and other major contamination events
  • Developed and implemented crisis management, client and media strategies for numerous clients facing food and supplement safety concerns and other crises
  • Successfully removed over 40 companies from Import Alert and successfully released goods detained by the FDA on more than 60 occasions
  • Developed global regulatory programs for eight different food and dietary supplement companies
  • Drafted/redrafted portions of food and dietary supplement regulations for numerous international governments
  • Managed numerous inspections of food facilities in the United States and internationally
  • Assisted clients in preparing responses to nearly 500 inspection reports, Warning Letters and Import Holds
  • Regularly advise financial institutions on developments in the food industry
  • Managed the preparation of Citizen Petitions, Generally Regarded as Safe (GRAS) affirmations and Food Additive Petitions
  • Participated in the development and implementation of a strategy that led to securing a health claim from the FDA
  • Counseled on numerous key international food and food ingredient standards, Including those for chocolate, juice, pesticide residues, nutrition labeling, and labeling of transgenically produced foods and dietary supplements, among many others
  • Negotiated with the FDA and Congress regarding major food legislation and rulemaking (e.g., strategy development, negotiation and drafting of comments), such as biotech derived food labeling, partially hydrogenated vegetable oils, bioterrorism legislation and the Food Safety Modernization Act (FSMA)
  • Developed label and advertising review strategies and led teams for approval
  • Negotiated resolutions to FDA and FTC challenges, as well as consent decrees and other enforcement actions Involving the FDA, FTC and the Department of Justice
  • Provided strategies and guidance for compliance with regulatory issues concerning cannabis

Medical Devices and Diagnostics

  • Assisted a major medical device manufacturer with a comprehensive review and overhaul of its SOPs related to recalls and risk management. Reviewed for legal sufficiency all interrelated SOPs, including those that deal with pre-approval, design, post-approval, field monitoring, health hazard events and reporting. and corrective action plans. Also provided product liability risk training to staff on proper documentation practices related to adverse event reporting and complaint handling
  • Assisted medical device companies in navigating FDA regulatory requirements and policies for medical mobile applications and Health IT Software for clinical support
  • Device reforms, reprocessed devices and combination products: aided medical device clients in working with the Office of Combination Products and provide guidance on implementation of policies on reprocessed devices and qualification for and use of the CDRH third-party device review and inspection programs
  • Secured the approval of several medical devices each year for more than 20 years
  • Cleared numerous medical aesthetic devices for pioneers in the medical aesthetic industry

Cosmetic and Personal Care Companies

  • Provided strategies concerning regulatory compliance, including cannabis-containing products

Compliance and Enforcement

  • Managed numerous recalls/market withdrawals and matters that involved significant reputational issues, including one instituted in the wake of a death
  • Assisted a client in managing FDA inspections of facilities in China
  • Regularly assist clients in responding to 483s and Warning Letters
  • Regularly assist clients on FDA importation detentions and obtaining product release

Government Relations and Public Policy

  • Involved in policy discussions surrounding several major pieces of legislation and rulemakings involving the FDA
  • Filed multiple Citizen Petitions involving medical devices and foods

Advertising and Social Media

  • Assisted client in revising website and other social media after FTC consent decree
  • Regularly advise clients on advertising substantiation and on social media issues
  • Represented clients in dual agency Investigations both by the FDA and FTC
  • Provided in-depth guidance to the advertising of cannabis-related products
  • Retained by some of the United States' biggest and best known public and private companies in their TCPA litigation, including a chain of American mid-range department stores and a global chain of fast-food restaurants