The current nutraceutical health sector & the next phase of the nutraceutical revolution

The Foundation for Innovation inMedicine 11th Nutraceutical Conference

February 3/4/2000, The Waldorf-Astoria, New York


The NREA (Nutraceutical Research & Education Act)


Written by Michael Mannion
February 3-4, 2000, The Waldorf-Astoria, New York
See press release: New FDA regulations published January 6th will be analyzed at FIM’s Nutraceutical Conference
The American public has wholeheartedly embraced the promise of nutraceuticals – and justifiably so. As a result, the nutraceutical health sector is on the verge of a fundamental change. The industry, now market-driven, will rapidly become clinical research-driven. Clinical studies of nutraceuticals will power the next stage of development. The question is not if, but when.
Although the majority of Americans are now using nutraceuticals (i.e., foods, medical foods, dietary supplements), they face a major problem. The market is flooded with products for which unsubstantiated medical-health claims are being made. The manufacturers’ claims are not substantiated by clinical research. Americans are increasingly aware of this situation and are beginning to express concerns about the nutraceutical industry.
The questions that the public is asking, in combination with an awareness of the enormous medical-health potential of nutraceuticals, will inevitably lead to the birth of a clinical research-driven nutraceutical industry in which companies will conduct studies to reasonably demonstrate the efficacy and safety of their specific products. This market will be a highly profitable one, generating sufficient profits to sponsor further nutraceutical clinical research.
The major obstacle to the emergence of these true nutraceutical companies is the unclear and confusing groundrules for making medical-health claims. For this reason, FIM has proposed the NREA (Nutraceutical Research & Education Act). The NREA was introduced in Congress on October 1, 1999 by Representative Frank Pallone (D-NJ). It is based on the successful principles of the Orphan Drug Act. See NREA page.
This conference will explore where we are today in The Nutraceutical Revolution and where we will be shortly. Included is an in-depth discussion of the NREA.


Antonino Amato, M.D. Medical Director, Sigma-Tau Pharmaceuticals,Inc.

Adrianne Bendich, Ph.D. Associate Director-New ProductResearch, SmithKline Beecham Consumer Healthcare

Mark Blumenthal, Ph.D.Executive Director, AmericanBotanical Council

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

Lyn CioccaPresident, Wellness Resources

Stephen L. DeFelice, M.D.Chairman, FIM (The Foundationfor Innovation in Medicine)

Derrick M. DeSilva, Jr., M.D.President, American NutraceuticalAssociation

FDA RepresentativeInvitation Accepted; Representativeto be Announced

Stephen P. Giannetti,Publisher, Prevention Magazine

Linda C. Gilbert,President, HealthFocus, Inc.

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

Robert A. Hoerr, M.D., Ph.D.President, Research-basedDietary Ingredient Association (RDIA) and President and CEO, GalaGenInc.

Paul A. Lachance, Ph.D.Executive Director, The NutraceuticalsInstitute -and- Professor of Nutrition & Food Science, Rutgers University

Louis Lasagna, M.D.Dean, Sackler School of GraduateBiomedical Sciences, Tufts University

Christine Lewis, Ph.D. Acting Director, The Officeof Nutritional Products, Labeling and Dietary Supplements, Foodand Drug Administration

Antonio C. Martinez, II, Esq.Attorney at Law, Government& Regulatory Affairs Counsel

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

Vic P. MicatiFormer President Pfizer Europe &Executive Vice-President, Pfizer Pharmaceuticals Group & VicePresident, Pfizer, Inc.

Representative Frank Pallone(D-NJ) Member, House CommerceSubcommittee on Health and the Environment

Richard S. Rivlin, M.D.Professor of Medicine &Chief, Nutrition Division, New York Hospital - Cornell MedicalCenter

Ed SlaughterMarket Research Director, Prevention Magazine

William M. Wardell, M.D., Ph.D.Senior Scientific Officer& Executive Director of the Institute for Drug Research, Covance