How to develop, make claims on and market medical foods

The Foundation for Innovation in Medicine - 7th Nutraceutical Conference

November 20 & 21, 1996
Hotel Inter-continental, New York City

The Foundation for Innovation in Medicine (FIM) announces a one and a half day conference that will provide the tools to research, develop and market medical foods – a category of nutraceuticals. A nutraceutical is a food or parts of foods that offer medical-health benefits including the prevention and/or treatment of disease. Medical foods, dietary supplements and other food or nutrient categories such as functional and designer foods are all nutraceuticals.

The Dietary Supplement Health & Education Act (DSHEA) has created confusion regarding the ground rules for health-medical claims. DSHEA permits companies to make claims to both consumers and physicians relating to structure function, mechanism of action, well-being and classic deficiences. It also, however, prohibits claims relating to the prevention and/or treatment of disease. This contradiction has caused companies to pause in their efforts to research and market dietary supplements. Although not yet quantifiable, many companies have turned their interest to the relatively obscure category of medical foods. A Medical Food is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. (Section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). It is important to note that a medical food must be administered under physician supervision.

This will be the first conference in which the medical food category will be explored in depth including specific medical food product presentations. The following categories will be addressed:

How to research and develop medical foods

  • the scientific and clinical evidence needed to justify claims and market a medical food
  • acceptable protocol designs and development costs of clinical trials What claims can be made
  • what types of health-medical claims are permissible, based primarily on data generated by clinical studies
  • how companies can maximize their claiming opportunities How to market medical products
  • how to determine the best marketing approach
  • what is going on in Congress, at the FDA, in the marketplace, and in cutting-edge research labs, that will shape the way companies develop and market medical foods

Case Histories

  • Cardia Salt Alternative: Clinically proven to lower blood pressure for the dietary management of hypertension
  • Neocate: Hypoallergenic infant formula
  • Zbar: Long-acting carbohydrate snack- reduces episodes of hypoglycemia
  • Hypothetical Herbal Remedy: For reduction of benign prostatic hypertrophy


Stephen L. DeFelice, M.D. Chairman, The Foundation for Innovationin Medicine

Mark DeFriestChief Executive Officer, SHS North America

Gary D. DraperSenior Vice President of Sales, Baker NortonPharmaceuticals, Inc.

Anthony GiovinazzoVice President, MDS Health Ventures CapitalCorporation

Peter Goldman, M.D. Professor of Health Science, Departmentof Nutrition, Harvard School of Public Health

Patricia KnightHealth Policy Advisor to Senator Orrin Hatch(R-UT), Chairman, Senate Judiciary Committee

Paul J. LaChance, Ph.D.Professor & Chairman, Rutgers University,Food Science Department

Louis Lasagna, M.D.Dean, Sackler School of Graduate BiomedicalSciences, Tufts University

Donald B. Louria, M.D.Professor & Chairman, UMDNJ - NewJersey Medical School, Department of Preventive Medicine

Franklin C. Lowe, M.D.MPH Associate Director, Department ofUrology, St. Luke's/Roosevelt Hospital Center

Antonio C. Martinez II, Esq.Calello Martinez P.C.

Stephen H. McNamara, Esq.Hyman, Phelps & McNamara, P.C.(former Associate Chief Counsel for Food, Food & Drug Administration)

Gerard Pilley, Ph.D.President Directeur General, Grand PublicS.A., Paris, France

Fredric D. PricePresident & CEO, Applied Microbiology,Inc.

Richard S. Rivlin, M.D.rofessor of Medicine & Chief,Nutrition Division, New York Hospital-Cornell Medical Center andProgram Director, Clinical Nutrition Research Unit, G.l. - NutritionService, Memorial Sloan-Kettering Cancer Center

Jay S. Skyler, M.D.Professor of Medicine, Pediatrics &Psychology, University of Miami School of Medicine

Jur T. Strobos, M.D., Esq.Greenberg, Traurig, P.C. (former Director,Policy Research, Office of the Commissioner, FDA)

Elizabeth Yetley, Ph.D.Director, Office of Special Nutritionals,Center for Food Safety & Applied Nutrition, Food & DrugAdministration