Mark Mansour has practiced U.S. and international food and drug law since 1991. He works with clients in the food, pharmaceutical, medical device, dietary supplement and cosmetic industries to secure regulatory approvals, maintain compliance and address public policy issues in the United States and in key global markets.
In addition to counseling corporations and organizations on how to negotiate effectively with government agencies, both domestically and internationally, Mr. Mansour assists clients in the development of strategies to manage the growing thicket of international regulatory requirements in the food and drug arena.
Practice & Background
Mr. Mansour is recognized as a pioneer in the development of strategies to open markets and manage nontariff barriers to trade that affect the international regulation of food, food additives and ingredients, dietary supplements, nutritional foods, pharmaceuticals, biotechnology, nanotechnology and a variety of other consumer-oriented products and processes. His approach to client relations is to serve as a business adviser, rather than solely as a legal adviser. He does so by providing counsel in a broad context that encompasses both business and legal considerations and by employing his ample experience in the formation of teams of experts from diverse backgrounds and cultures to manage complex legal and public policy projects. He has worked with regulators in the United States, Canada, Mexico, Brazil, Argentina, Chile, the European Union, the Middle East, North Africa and Gulf Cooperation Council (GCC) countries, South Africa, Turkey, Japan, Korea, Singapore, Malaysia, China and Australia, among other major global markets.
Mr. Mansour is an active participant in governmental, intergovernmental and international industry groups keyed to his interest and work in the consumer product, food, dietary supplement and biotechnology industries. He is also active in a variety of international public policy matters governing the food and drug trade, advising multinational food and drug producers and trade associations, while working closely with congressional offices and U.S. government agencies on trade matters. The Egyptian and Kuwaiti governments each invited his participation in the drafting of their environmental laws, which took unique advantage of his skills in regulatory affairs coupled with his fluency in Arabic and cultural understanding. Mr. Mansour continues to be a leading participant and speaker on a variety of regulatory and trade issues affecting the regulated consumer products industries and other emerging technologies, addressing regulators, public policy leaders and scientists in countries around the world and often participating in programs sponsored by leading U.S. agencies, including the Department of Agriculture and the Department of State.
Prior to entering private practice, Mr. Mansour served as assistant general counsel and director of global regulatory affairs with two of the world’s largest food companies, where he led the development and implementation of the companies’ global regulatory strategies. He chaired a multidisciplinary team that set policies and global strategies in the areas of health and nutrition claims, fortification, packaging, food safety, FDA compliance and removal of international regulatory and trade barriers. Mr. Mansour is active in a variety of international public policy matters, advising multinational food and drug producers and trade associations and working closely with congressional offices and U.S. government agencies on regulatory and trade issues affecting regulated industries. Consequently, Mr. Mansour is able to offer clients the benefit of his international and public policy credentials coupled with his mutually complementary set of experiences at major multinational corporations, in private law firm practice and as a former staff member of the U.S. House of Representatives.
Mr. Mansour’s recent representations include:
- representing a specialty pharmaceutical manufacturer in litigation over FDA approval of a landmark injectable drug; assisting in securing a successful approval, and in subsequent related patent infringement cases; part of a team securing a stay from the U.S. Federal Circuit Court of Appeals of a Preliminary Injunction issued by a District Court
- preparing 510(k) applications that secured FDA clearance of various medical advanced therapeutic medical devices
- advising several pharmacy clients on FDA regulation of compounding practices and advertising under the FDA Modernization Act and relevant case law
- defending several device and drug vendors against FDA enforcement actions, including seizure, product recalls, inspections and civil monetary penalties
- representing the animal health division of a foreign multinational pharmaceutical company in getting legislation passed by Congress requiring the FDA to expedite approval of a new class of animal drugs that improve food safety
- counseling clinical investigators and sponsors regarding permissible labeling, promotion and charging for investigational drugs and devices
- working with companies regarding the development and distribution of drugs, devices, biologics, orphan drugs, food, food additives, animal feeds and cosmetics
- assisting a major multinational producer in securing a health claim from the FDA
- representing several major multinational corporations in civil and criminal investigations relating to foodborne illness outbreaks and pharmaceutical and medical device safety issues
- advising governments regarding revision and drafting of their food and drug laws
- developing labeling for numerous food and dietary supplement products in compliance with FDA’s nutrition labeling and dietary supplement laws
- working with manufacturers in the development and distribution of food, food additives, animal feeds and dietary supplements
- assisting clients in responding to FDA inspections in the U.S. and at overseas facilities
- developing labeling for foods and dietary supplement products in compliance with the FDA’s food nutrition labeling and dietary supplement labeling regulation laws
- advising companies throughout the supply chain regarding global strategies related to biotechnology and nanotechnology regulation and labeling.
Mr. Mansour is involved in numerous community, civic and charitable activities that include being a:
- member of the advisory council of the World Food Law Institute
- member of the ABA Section on International Law.
Awards & Accolades
- recognized by Super Lawyers in the FDA, government relations and international practice areas in 2013
- “Emerging Markets for Dietary Supplements and Cosmetics: Key Compliance, Safety and Regulatory Issues,” Food and Drug Law Institute’s 55th Annual Conference (April 24, 2012)
- “FDA/Park Doctrine – Off Label Marketing,” Thomson-Reuters webinar (September 27, 2011)
- “Auditing & Monitoring Compliance within the Food Manufacturing, Distribution and Supply Chain,” 2nd Annual Advanced Summit on Food Safety Regulatory Compliance (June 16, 2011).