How to develop, make claims on, and market nutraceuticals

The Foundation for Innovation in Medicine's Fourth NutraceuticalConference

May 16 and 17, 1995
The Waldorf-Astoria, New York City

The Foundation for Innovation in Medicine announces a 1 %-dayconference that will provide companies with the tools to developand market nutraceuticals. A nutraceutical is a food or partsof foods that offer medical-health benefits, including preventionand/or treatment of disease. Stephen L. DeFelice, M.D. coinedand defined the term “nutraceutical” in order to createa single category which would cover a broad list of terms suchas dietary supplements, functional foods, designer foods, hypernutritiousfoods, pharmafoods, certain categories of phytochemicals, etc.It can be a pill, drink, cereal, or other formulation. Ideally,the formulation should be the most appropriate delivery systemfor the active ingredient(s) in the product.

Last October’s passage of the Dietary Supplement Health &Education Act (DSHEA), and the arrival of the new Congress havedramatically expanded the potential market for nutraceuticals.For example, food companies are not aware that the DSHEA offerssubstantial claiming opportunities beyond the limits of the NutritionLabeling & Education Act (NLEA). Leading experts will discusskey trends in the nutraceutical field. Panels of academic andindustry experts will apply the case method to evaluate the developmentand marketing plans for different and specific types of nutraceuticalproducts such as foods, dietary supplements and herbal remedies.For example, clinical data will be presented concerning the effectivenessof magnesium chloride for cardiomyopathy. Are the data sufficientto support the claim? Are more data needed? If so, what type ofdata and what will they cost? If the data are convincing, whatclaims can companies make under present regulations, and how cana company market the product? These same basic questions willbe asked for all the case examples. Nutraceuticals truly representan immediate and exciting opportunity and challenge to the food,OTC, pharmaceutical, and supplement industries.


The panelists will explore, in depth, for each product:

How to develop it

  • the scientific and clinical evidence needed to justify claims and market a nutraceutical
  • the accepted 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 within the elastic gray zone created by the DSHEA

How to market nutraceutical 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 nutraceuticals


Nancy M. Childs, Ph.D.Professor of Food Marketing, St. Joseph'sUniversity

Lyn CioccaDirector, Trident Group

J. B. CordaroPresident, Council for Responsible Nutrition

Michael H. Davidson, M.D.Medical Director, Chicago Centerfor Clinical Research, Inc.

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

Joseph A. DiPalma, M.D.Emeritus Dean and Professor of Pharmacology,Hahnemann University School of Medicine

Kathleen B. DrennanPresident & COO, Chicago Center forClinical Research, Inc.

Juanita Duggan Executive Vice President for Government Affairs& Communications, National Food Processors Association

Victor L. Fulgoni, III, Ph.D.Vice President, Nutrition, KelloggCompany

Abdul Gaffar, Ph.D. Vice President, Advanced Technology-Oral,Research & Technology Division, Colgate-Palmolive Company

Thomas D. Giles, M.D.Professor of Medicine, Director of ardiovascularResearch, Louisiana State University Medical Center

Nicholas HallPresident, Nicholas Hall & Company, Essex,United Kingdom

Ronald K. JenkinsProduct Manager, Low Fat Ingredient Systems,Rhone-Poulenc

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

William E. LearnardManaging Director, Trident Group (formerChairman, NDMA and former President, SmithKline Consumer Products)

Gilbert A. Leveille, Ph.D.Vice President, Research & TechnicalServices, Nabisco Foods Group

Robert J. Levine, M.D. Professor of Medicine, Yale UniversitySchool of Medicine

Tony MartinezDirector of Government Affairs, Nutritional HealthAlliance

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

Gerard Pilley, Ph.D.President Directeur General, LaboratoiresLincoln, Paris, France

Fredric D.Price President, Applied Microbiology, Inc.

Marcel B. RoberfroidFull Professor, Biochemistry and Toxicology,Universite Catholique de Louvain, School of Pharmacy, Louvain,Belgium

Cyrill SiewertManaging Director, Siewert Associates

Jerry E. Silverman, R.Ph.President, BIMARK Inc.

A. Elizabeth Sloan, Ph.D.President, A. E. Sloan & Associates,and contributing editor of Food Technology

Robert E. Smith, Ph.D. Senior Vice President, Research, NabiscoFoods Group