Dr. Mitchell Cheeseman

Managing Director, Regulatory & Industry Affairs Department
1330 Connecticut Avenue, NW
Washington DC 20036
TEL: +1 202 429 6473
FAX: +1 202 429 3902

Dr. Mitchell Cheeseman is a managing director at Steptoe, where he is a member of the Environment & Life Sciences Group.  He has 20 years of experience as an official at the US Food and Drug Administration.  Dr. Cheeseman primarily assists manufacturers in achieving and documenting regulatory compliance for products regulated by FDA and EPA.  He also provides the same assistance to clients marketing such products in the European Union (EU), China, South America and Asia.  He has experience assisting such manufacturers with issues regarding both premarket approval and compliance issues as well as postmarket issues including compliance with the Food Safety Modernization Act (FSMA) and implementing regulations.  He provides strategic advice in support of product research and development to optimize return on investment with respect to regulatory requirements and market entry.

Dr. Cheeseman left FDA in November 2011 after serving more than five years as a member of the leadership of the Center for Food Safety and Applied Nutrition.  In this capacity, he led FDA’s food ingredient and packaging programs including primary responsibility for the regulation of direct food additives and food contact substances, color additives, Generally Recognized as Safe (GRAS) food ingredients, and bioengineered food.  Dr. Cheeseman served as the primary contact for advice on regulatory science and policy to all other FDA product centers in areas where FDA’s Office of Food Additive Safety had primary or overlapping regulatory responsibility and where FDA/OFAS had specialized expertise in regulatory science.  As such, he dealt closely with scientists and policymakers in FDA’s medical device and drug programs as well as in the Center for Veterinary Medicine and the Center for Tobacco Products.  During his tenure he provided guidance and negotiated policy on significant issues including the regulation of colors in medical devices, the safety of plastic materials used in the manufacturing and packaging of medical devices and drugs, regulatory policy on nanotechnology and the safety of certain substances (e.g. Bisphenol A and phthalates), which cut across multiple product areas.

Dr. Cheeseman has diverse experience dealing with policy issues regarding chemical risk assessment and regulation including experience navigating cross-jurisdictional issues involving regulation by FDA, USDA, CPSC, TTB, and EPA.  As the acting director and deputy director of FDA’s Office of Food Additive Safety, he led enforcement activities on a wide range of areas.  He has substantial experience working with a wide range of food and food packaging companies as well senior governmental officials in US and foreign regulatory agencies, members of the press, and Congressional staff.  

Dr. Cheeseman has been an invited speaker and participant at many international meetings, workshops, and working groups regarding the use of probabilistic risk assessment in the regulation of chemicals and the Threshold of Toxicological Concern (TTC).  His work regarding structural alerts for carcinogenicity is the primary basis for the cancer thresholds in the existing TTC approach applied to the regulation of food flavors by the FAO/WHO Joint Expert Committee on Food Additives and by FDA to the regulation of food contact materials.  In addition, his work is the basis for the current regulatory standards for genotoxic impurities in pharmaceuticals which have been adopted by the European Medical Products Agency (EMEA) and the US Food and Drug Administration Center for Drug Evaluation and Research.  He has been an invited expert for consultations on regulatory science sponsored by such organizations as the United Nations Food and Agricultural Organization, the European Food Safety Authority, and the International Life Sciences Institute as well as serving as an ad hoc member of the Science Advisory Panel for the Environmental Protection Agency Office of Pesticide Programs and Toxics.

In addition, he has substantial experience working on FDA’s development and implementation of legislation including the Food Quality Protection Act, the FDA Modernization Act, the Public Health Security and Bioterrorism Preparedness and Response Act, the Antimicrobials Technical Corrections Act, and the FDA Amendments Act.

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Professional Affiliations

  • Current IFT representative to the Codex Committee on Food Additives