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Stephen L. DeFelice, MD


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NREA, Nutraceutical Research and Education Act


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The Patient Always
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Carnitine-Ovarian Cancer Promise and a Failed Attempt at a Clinical Study


When Was The Last Cure?


Translational Science - How Doctornauts Can Help


Senator Tom Harkin (D-IA) has been one of the leaders in Congress on Translational Science.


Doctornauts Barry Marshall and Lukas Wartman: Living Proof of the Urgent Need for the Doctornaut Act



View the Discussion Draft of the Doctornaut Act Prepared by Former Senator Bill Frist.




The Foundation for Innovation in Medicine 11th Nutraceutical Conference

THE CURRENT NUTRACEUTICAL HEALTH SECTOR & THE NEXT PHASE OF THE NUTRACEUTICAL REVOLUTION

-including-

The NREA (Nutraceutical Research & Education Act)


EXTENSIVE SUMMARY OF THIS CONFERENCE
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.

 

CONFERENCE PARTICIPANTS

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

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

Mark Blumenthal, Ph.D., Executive Director, American Botanical Council

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

Lyn Ciocca, President, Wellness Resources

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

Derrick M. DeSilva, Jr., M.D., President, American Nutraceutical Association

FDA Representative, Invitation Accepted; Representative to be Announced

Stephen P. Giannetti, Publisher, Prevention Magazine

Linda C. Gilbert, President, HealthFocus, Inc.

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

Robert A. Hoerr, M.D., Ph.D., President, Research-based Dietary Ingredient Association (RDIA) and President and CEO, GalaGen Inc.

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

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

Christine Lewis, Ph.D. , Acting Director, The Office of Nutritional Products, Labeling and Dietary Supplements, Food and 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. Micati, Former President Pfizer Europe & Executive Vice-President, Pfizer Pharmaceuticals Group & Vice President, Pfizer, Inc.

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

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

Ed Slaughter, Market Research Director, Prevention Magazine

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

 


The Foundation for Innovation in Medicine 10th Nutraceutical Conference

NUTRACEUTICALS & PHARMACEUTICALS TAKEN TOGETHER: A NEW HEALTH SECTOR

plus

A New FIM Congressional Proposal: The Nutraceutical Research & Education Act - NREA

Read the FIM Rationale and Proposed Guidelines for the Nutraceutical Research & Education Act - NREA that was proposed at this conference. Click on this text.

November 10-11, 2002, The Waldorf-Astoria, New York

 

Nutraceuticals (include the legal-regulatory entities dietary supplements, foods and medical foods) are being consumed together with pharmaceuticals by a large percentage of the U.S. population. We must assume that to a significant degree, nutraceuticals and pharmaceuticals interact with each other, having a significant impact on disease- either beneficially or detrimentally. There is little doubt that this potentially enormous new health sector already exists. There is also little doubt that the medical community, health industry, and federal government are not addressing this new explosive health sector.

FIM announces a 1 1/2 day conference which will present the current information on the business and regulatory aspects of foods, medical foods and dietary supplements. Also included will be presentations on actual or virtual clinical trials of nutraceuticals and pharmaceuticals taken together. A medicine versus law panel regarding claims will follow each presentation. The physicians will propose claims based on the clinical data itself. The lawyers will propose claims based on federal law and regulations.

Products to be discussed are Benecol, Ocean Spray Cranberry Juice, St. John's Wort, Intelligent Quisine, Zocor, Cispro, Prozac and Antihypertensive Pharmaceuticals.

 

The Nutraceutical Research & Education Act - NREA

In 1991 FIM published its white paper, "The Nutraceutical Initiative: A Proposal for Economic and Regulatory Reform". In it FIM called for Congress to enact The Nutraceutical Research & Education Act NREA. We believe that this proposal may be a timely solution to the current state of confusion which would expedite the establishment of a vigorous research-oriented nutraceutical industry.

Authorities from various health sectors will participate and make comments and recommendations on the FIM proposal, including members of Congress, both the House and the Senate corporate medical and legal thought leaders, who play key roles in formulating U.S. health policy. There is little doubt that the time has come for new nutraceutical laws and regulations.

NEWS ADVISORY

FDA announced it intends to seize cholesterol lowering Benecol margarine and ban it as a dietary supplement.

 

CONFERENCE PARTICIPANTS

Thomas D. Aarts, Executive Editor, Nutrition Business Journal

Nilo Cater, M.D., Nutrition Scholar, Center for Human Nutrition, University of Texas, Southwestern Medical Center at Dallas

Lyn Ciocca, President, Wellness Resources

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

Grant W. Denison, Jr., Chairman & CEO, BioMarin Pharmaceutical, Inc.

Senator Bill Frist, M.D. (R-Tenn), Chairman, Senate Labor and Human Resources Public Health and Safety Subcommittee

Carl Germano, RD, CNS, LDN, Vice President Product Development, Solgar Vitamin & Herbs

Samuel Gershon, M.D., Professor of Psyehiatry, University of Pittsburgh

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

Enrique J. Guardia, Ph.D., Former Vice President Technology, General Foods USA

Senator Tom Harkin (D-lowa), Ranking Member, Senate Appropriations Labor, Health and Human Services Subcommittee

Robert A. Hoerr, M.D., Ph.D., President, Research-based Dietary Ingredient Association (RDIA) and President and CEO, GalaGen Inc.

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

Franklin C. Lowe, M.D., MPH, Associate Clinical Professor of Urology, Columbia University & Associate Director, Dept. Urology, St. Luke's/Roosevelt Hospital

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

C. Kenneth Mehrling, Executive Vice President, General Manager, Sigma-Tau Pharmaceuticals, Inc.

Abbey S. Meyers, President, NORD (National Organization for Rare Disorders, Inc.)

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

Lawrence M. Resnick, M.D., Professor of Medicine & Director of Hypertension, Wayne State University, School of Medicine

Jur Strobos, M.D., J.D., Greenberg Traurig and former Director, Policy Research, Office of the Commissioner, FDA

John P. Troup, Ph.D., Vice President, Scientific Affairs, General Nutrition Corporation

Joseph M. Valenzano, Jr., President, CEO & Publisher, Exceptional Parent Magazine

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

Rhonda Witwer, Manager, Business Development, Monsanto

 


9th Nutraceutical Conference

THE NUTRACEUTICAL REVOLUTION:

(Re: Foods, Dietary Supplements & Medical Foods)

ITS IMPACT ON THE FOOD & DRUG INDUSTRIES

May 20, 21, 2002, The Waldorf-Astoria, New York

 

FIM, as a continuation of the Nutraceutical Initiative, announces a one and a half day conference which will address the impact of the Nutraceutical Revolution on corporate research, development and commercialization of foods, dietary supplements and medical foods. The regulatory and commercial distinctions between the food and drug industries continue to blur. For this reason all three major nutraceutical categories have been included in the program. The conference moderator will be Stephen L. DeFelice, M.D. and the program will be divided into three sections as follows:

 

SECTION I

THE BOUNDARIES & CORPORATE FLEXIBILITY REGARDING HEALTH-MEDICAL CLAIMS

Opinions of legal experts vs. opinions of non-legal experts such as corporate executives and medical authorities on the range of freedom regarding making health-medical claims will be presented. There is little doubt that corporate confusion regarding what can and what cannot be claimed has had a significant inhibiting effect on the research, development and commercialization of nutraceuticals. Case histories will be discussed, including Pharmanex, and a panel discussion will be included in this segment of the program. Anticipated future Congressional and FDA activities regarding health-medical claims will also be presented.

 

SECTION II

INFORMATION REGARDING MARKET PATTERNS AND RESEARCH DEVELOPMENTS

Presentations on market research information and new developments in proprietary technology will be presented. Consumer trends and market size information will also be included.

 

SECTION III

COMMERCIALIZATION: STRATEGIES FOR COMPANIES TO ENTER THE NUTRACEUTICAL MARKET

This section will be divided into two parts:

A. Presentations on how specific companies are commercializing dietary supplements, medical foods and foods. A special presentation will be made regarding botanical nutraceuticals.

B. A panel that will discuss (given the nature of the health-medical claim boundaries) ways in which nutraceutical companies can research, develop and commercialize nutraceutical products.

 

CONFERENCE PARTICIPANTS

Thomas D. Aarts, Executive Editor, Nutrition Business Journal

Daniel Best, President, Best Vantage, Inc.

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

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

Grant W. Denison, Jr., Chairman and CEO, BioMarin Pharmaceutical, Inc.

Robert G. Donovan, Consultant (former Chairman of NDMA (Nonprescription Drug Manufacturers Association))

Victor L. Fulgoni, III, Ph.D., Vice President Worldwide Nutrition Science,

W.K. Kellogg, Institute for Food and Nutrition Research

Loren D. Israelsen, President, LDI Group

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

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

Charles H. Manley, Ph.D., Vice President, Science & Technology, Takasago International Corporation

Antonio C. Martinez, 11, Esq., Attorney at Law, Government & Regulatory Affairs Counsel

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

W. Patrick Noonan, Esq., Consultant for Regulatory Affairs, Pharmanex, Inc. --and- Law Offices, W. Patrick Noonan, A Professional Corporation

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

Charles J. Raubicheck, Esq., Partner, Sidley & Austin (former Associate Chief Counsel for Enforcement, Food & Drug Administration)

John P. Troup, Ph.D., Vice President, Scientific Affairs, General Nutrition Corporation (GNC)

Rhonda Witwer, Business Development Manager, Monsanto

 


 

THE FOUNDATION FOR INNOVATION IN MEDICINE - 8TH NUTRACEUTICAL CONFERENCE

CARDIOVASCULAR NUTRACEUTICALS: THEIR PROPER ROLE IN HEALTH & MEDICINE

 

October 14 & 15, 1997
Capital Hilton Washington, DC

The Foundation for Innovation in Medicine (FIM) announces a one and a half day conference on the proper use of cardiovascular nutraceuticals in health and medicine. 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 (including botanical substances) and other food or nutrient categories such as functional and designer foods are all nutraceuticals.

The positive clinical data on cardiovascular nutraceuticals far exceeds those of other nutraceutical categories such as anti-tumor and memory enhancer ones. Though the data on cardiovascular nutraceuticals are highly promising and exciting, there remains a critical dilemma concerning their proper use regarding efficacy and safety. Who should receive these substances and at what doses? Should they be given together with pharmaceuticals to enhance the efficacy and safety of the latter? What are the principles involved in making judgments regarding the use of cardiovascular nutraceuticals? All these issues will be addressed by a group of physician experts in this field who will both present the data and offer opinions. These opinions will be discussed by the participants and the attendees.

This will be the first major conference in the United States in which the clinical role of cardiovascular nutraceuticals will be explored in-depth by expert physicians.

 

During the morning of the first day, topics to be covered are:

Nutraceutical Revolution Update: The Cardiovascular Promise

NIH Office of Dietary Supplements: Update on Activities

Medical Foods & Dietary Supplements: Regulatory Update

Nutraceuticals: Industry Point of View

US. Cardiovascular Nutraceuticals: Market Overview

 

The Cardiovascular Nutraceuticals to be discussed are:

Vitamin E

Folic Acid

Carnitine

Magnesium (in Diabetes)

CoQ-10

Alcohol

Garlic

Special Diets (Intelligent Quisine)

Salt Alternative (Cardia)

 

CONFERENCE PARTICIPANTS

Thomas D. Aarts Executive Editor, Nutrition Business Journal

Andrew G. Bostom, M.D., M.S. Assistant Professor of Medicine, Brown University; also Director of Cardiovascular Disease Risk

Factor Management Clinic, Rhode Island Hospital

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

Joseph R. DiPalma, M.D. Emeritus Dean & Professor of Pharmacology, MCP/Hahnemann University School of Medicine

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

Bernadette M. Marriott, Ph.D. Director, Office of Dietary Supplements, National Institutes of Health, Department of Health & Human Services

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

Jerry L. Nadler, M.D. Director, Department of Diabetes, Endocrinology & Metabolism, City of Hope Medical Center; also Adjunct Associate Professor, University of Southern California

Carl J. Pepine, M.D. Professor of Medicine, University of Florida, College of Medicine, Division of Cardiology

Lawrence M. Resnick, M.D. Professor of Medicine & Director of Hypertension, Wayne State University, School of Medicine

Eric B. Rimm, ScD Assistant Professor of Nutrition & Epidemiology, Department of Nutrition, Harvard Medical School

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

George F. Schreiner, M.D., Ph.D. Vice President, Cardiorenal Research, Scios Inc.

David H. G. Smith, M.D. Director, Orange County Heart Institute & Research Center; also Director of Research Operations, Department of Clinical Pharmacology and Hypertension, Veterans Affairs Medical Center

John P. Troup, Ph.D. Vice President, Scientific Affairs, General Nutrition Corporation

 


 

The Foundation for Innovation in Medicine - 7th Nutraceutical Conference

HOW TO DEVELOP, MAKE CLAIMS ON AND MARKET MEDICAL FOODS

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

 

CONFERENCE PARTICIPANTS

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

Mark A. DeFries Chief Executive Officer, SHS North America

Gary D. Draper Senior Vice President of Sales, Baker Norton Pharmaceuticals, Inc.

Anthony Giovinazzo Vice President, MDS Health Ventures Capital Corporation

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

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

Paul A. Lachance, Ph.D. Professor & Chairman, Rutgers University, Food Science Department

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

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

Franklin C. Lowe, M.D, MPH Associate Director, Department of Urology, 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 Public S.A., Paris, France

Fredric D. Price President & CEO, Applied Microbiology, Inc.

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

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

Jur 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 & Drug Administration

 


 

The Foundation for Innovation in Medicine's Sixth Nutraceutical Conference

THE NEED FOR A RESEARCH-INTENSIVE NUTRACEUTICAL INDUSTRY: WHAT CAN CONGRESS DO?

(The Claims-Research Connection)

 

May 9, 1996
The Hyatt Regency Washington On Capitol Hill, Washington, DC

A nutraceutical is a food or parts of food that offer medical-health benefits, including prevention and/or treatment of disease.

FACT: It was hoped that the passage of the Dietary Supplement Health & Education Act (DSHEA) would lead to a research-intensive nutraceutical industry. The unfortunate conclusion, however, of the Foundation's last nutraceutical conference was that it would not. When asked, "Who understands DSHEA?", only 1 of the 161 participants responded in the affirmative - a dramatic example of (a) the confusion surrounding DSHEA and its negative impact on research, and (b) the urgent need for new laws to encourage such research.

FACT: There is, however, very good news. At the same conference, representatives from all walks of the health care community, ranging from industry and government to consumer groups, unanimously stressed the appreciation of the urgent need for research which has to date -- except for efforts of our Foundation - been absent in the national dialogue.

FACT: A key conclusion of the fifth nutraceutical conference was the unanimous recognition of the critical importance of the claims-research connection: The more reasonable the claiming system, the more research would be funded by industry.

It is time that we hear from potential players from the nutraceutical industry, itself, regarding what Congress can do to establish a research-intensive nutraceutical industry that would make a major positive impact on the lives of both the healthy and the sick. This conference will focus on this single, critical issue.

 

The general format of the conference is as follows:

  • Representatives of the food, OTC and herbal remedy industries will present opinions of industry leaders, obtained by informal interviews.
  • A panel of experts along with the audience will discuss the results of these interviews.
  • The conclusions and recommendations of such discussions will be written at the meeting itself utilizing computer projection where all can participate.
  • Senators Bill Frist, M.D. (R-TN) and Tom Harkin (D-IA) along with Representative Peter DeFazio (D-OR) will, after the recommendations are written, join us to hear and discuss them.
  • Senator Bill Frist, M.D. (R-TN), the Senate's only physician, is a national leader in health matters.
  • Senator Tom Harkin (D-IA) is the founder of the National Institutes of Health Office of Alternative Medicine and prime co-sponsor of DSHEA.
  • Representative Peter DeFazio (D-OR) is the prime sponsor of the Access to Medical Treatment Act and co-sponsor of DSHEA.

 

The day concludes with a reception where conference participants and attendees, along with Senators Frist and Harkin as well as Representative DeFazio and their staffs, can meet and mingle to carry on the dialogue.

 

SPEAKERS

Lyn Ciocca, President and General Manager, IntraCellular Nutraceuticals, Inc.

Representative Peter DeFazio (D-OR), Member of the Resource Committee and Transportation Infrastructure Committee

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

Robert G. Donovan, Consultant, and former Chairman of NDMA (Nonprescription Drug Manufacturers Association)

Senator Bill Frist, M.D. (R-TN), Senate Labor and Human Resources Committee; Chairman-Senate Subcommittee on Disability Policy; Senate Budget Committee; Senate Small Business Committee

Victor L. Fulgoni, 111, Ph.D., Vice President, Nutrition, Science & Technology Center, Kellogg Company

Senator Tom Harkin (D-IA), Senate Labor and Human Resources Committee; Ranking Member-Senate Subcommittee on Disability Policy; Senate Agriculture, Nutrition and Forestry Committee; Ranking Member-Subcommittee on Research, Nutrition and General Legislation; Senate Appropriations Committee; Ranking Member-Labor, HHS, Education Subcommittee; Senate Small Business Committee

 

PANELISTS

David Collins, Consultant and former Chairman of NDMA

Stephen L. DeFelice, M.D.

Robert G. Donovan

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

Enrique J. Guardia, Ph.D., Consultant and former Group Vice President, Technology, Kraft General Foods

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

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

Robert E. Smith, Ph.D., Senior Vice President, Research, Nabisco, Inc. and President-Elect of the Institute of Food Technologists

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

 


 

The Foundation for Innovation in Medicine's Fifth Nutraceutical Conference

NUTRACEUTICAL UPDATE FROM WASHINGTON: DSHEA AND CLAIMS

November 15, 1995
The Hyatt Regency Washington On Capitol Hill, Washington, DC

FACT: The U.S. Congress passed the Nutrition Labeling & Education Act (NLEA) and Dietary Supplement Health & Education Act (DSHEA) to insure that the public has truthful information regarding the benefits of nutraceuticals. A nutraceutical is a food or parts of food that offer medical-health benefits, including prevention and/or treatment of disease. Stephen L. DeFelice, M.D. coined and defined the term "nutraceutical" in order to create a single category which would cover a broad list of terms such as dietary supplements, functional foods, designer foods, hypernutritious foods, 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 system for the active ingredient(s) in the product.

FACT: In the fields of medicine and health, truthful information is generated by data and information obtained through basic and clinical research.

FACT: There is comparatively little nutraceutical-oriented basic-clinical research. There is, therefore, relatively little truthful information available for educational purposes.

FACT: The proven way to generate basic-clinical nutraceutical research is via a vigorous industryacademic research-oriented complex such as in the traditional pharmaceutical and biotechnology industries.

FACT: Clear regulatory ground-rules for disease-health claims are necessary to attract corporate investment in nutraceutical research.

QUESTION: Are the DSHEA ground-rules for claiming unclear and contradictory, powerfully discouraging investment in nutraceutical research?

QUESTION: Should Congress modify the DSHEA claiming ground-rules to stimulate industrial support of basic-clinical nutraceutical research?

The Foundation for Innovation in Medicine will hold a one-day conference in Washington, DC, to review the claiming ground-rules of DSHEA and discuss ways of improving them. Leaders from the Congress, industry, academic medicine, and other interested groups will participate in what promises to be a stimulating and enlightening day that includes opportunities for meeting people from all quarters of the nutraceutical world.

The session, "Physicians vs. the Lawyers" will highlight the divergent views of medical and legal practitioners as to what constitutes a truthful claim. After reviewing the clinical data on four products, the doctors will present what they consider truthful claims about these products. The lawyers will then evaluate whether such claiming language, i.e., the truth, would be permitted under the DSHEA. The answer? Come hear the debate!

Senator Tom Harkin (D-IA), the founder of the National Institutes of Health Office of Alternative Medicine, and Representative Frank Pallone (D-NJ-6), who has submitted the Food and Dietary Supplement Consumer Information Act (HR.1951), will join representatives of various segments of the nutraceutical health community to comment on the claiming dilemma. A panel will then review and analyze these comments, and discuss ways of improving the breadth and nature of the claiming groundrules in a way that will stimulate substantial increases in investment in nutraceutical research.

Three afternoon presentations will review how the food, traditional dietary supplement, and herbal remedy industries have interpreted DSHEA, and examine the claims that companies are actually making. These will be followed by a presentation on the nutraceutical industry as an investment opportunity.

The day concludes with a reception where conference participants and attendees and Congressional staff can meet and mingle and speak with Senator Bill Frist, M.D. (R-TN), the Senate's only physician.

 

CONFERENCE PARTICIPANTS

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

Lyn Ciocca, Director, Trident Group

John B. Cordaro, President, Council for Responsible Nutrition

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

Juanita Duggan, Executive Vice President for Government Affairs & Communications,

National Food Processors Association

Senator Bill Frist, M.D. (R-TN), Senate Labor and Human Resources Committee; Chairman-Senate Subcommittee on Disability Policy; Senate Budget Committee; Senate Small Business Committee

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

Senator Tom Harkin (D-IA), Senate Labor and Human Resources Committee; Ranking Member-Senate Subcommittee on Disability Policy; Senate Agriculture, Nutrition and Forestry Committee; Ranking Member-Subcommittee on Research, Nutrition and General Legislation; Senate Appropriations Committee; Ranking Member-Labor, HHS, Education Subcommittee; Senate Small Business Committee

Patricia Hausman, President, NutriProse

Loren D. Israelsen, Esq., Attorney at Law

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

Robert J. Levine, M.D., Professor of Medicine, Yale University School of Medicine

Tony Martinez, J.D., Director of Government Affairs, Nutritional Health Alliance

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

Rep. Frank Pallone, Jr. (D-NJ-6), Author HR.1951 Food and Dietary Supplement Consumer Information Act; Member-House Commerce Committee; Subcommittee on Health and Environment

Stuart M. Pape, Esq., Patton Boggs, L.L.P. (former Executive Assistant to the Commissioner, FDA)

Fredric D. Price, President and Chief Executive Officer, Applied Microbiology, Inc.

Fred R. Shank, Ph.D., Director, Center for Food Safety & Applied Nutrition, FDA

Bruce A. Silverglade, Director of Legal Affairs, Center for Science in the Public Interest

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

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

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

 


 

The Foundation for Innovation in Medicine's Fourth Nutraceutical Conference

HOW TO DEVELOP, MAKE CLAIMS ON, AND MARKET NUTRACEUTICALS

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

The Foundation for Innovation in Medicine announces a 1 %-day conference that will provide companies with the tools to develop and market nutraceuticals. A nutraceutical is a food or parts of foods that offer medical-health benefits, including prevention and/or treatment of disease. Stephen L. DeFelice, M.D. coined and defined the term "nutraceutical" in order to create a single category which would cover a broad list of terms such as dietary supplements, functional foods, designer foods, hypernutritious foods, 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 system for 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 have dramatically expanded the potential market for nutraceuticals. For example, food companies are not aware that the DSHEA offers substantial claiming opportunities beyond the limits of the Nutrition Labeling & Education Act (NLEA). Leading experts will discuss key trends in the nutraceutical field. Panels of academic and industry experts will apply the case method to evaluate the development and marketing plans for different and specific types of nutraceutical products such as foods, dietary supplements and herbal remedies. For example, clinical data will be presented concerning the effectiveness of magnesium chloride for cardiomyopathy. Are the data sufficient to support the claim? Are more data needed? If so, what type of data and what will they cost? If the data are convincing, what claims can companies make under present regulations, and how can a company market the product? These same basic questions will be asked for all the case examples. Nutraceuticals truly represent an 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

 

CONFERENCE PARTICIPANTS

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

Lyn Ciocca Director, Trident Group

J. B. Cordaro President, Council for Responsible Nutrition

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

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

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

Kathleen B. Drennan President & COO, Chicago Center for Clinical Research, Inc.

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

Victor L. Fulgoni, III, Ph.D. Vice President, Nutrition, Kellogg Company

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 ardiovascular Research, Louisiana State University Medical Center

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

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

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

William E. Learnard Managing Director, Trident Group (former Chairman, NDMA and former President, SmithKline Consumer Products)

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

Robert J. Levine, M.D. Professor of Medicine, Yale University School of Medicine

Tony Martinez Director of Government Affairs, Nutritional Health Alliance

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

Gerard Pilley, Ph.D. President Directeur General, Laboratoires Lincoln, Paris, France

Fredric D. Price President, Applied Microbiology, Inc.

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

Cyrill Siewert Managing 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, Nabisco Foods Group



 

NUTRACEUTICAL RESEARCH, DEVELOPMENT & MARKETING: TIME TO MOVE FORWARD?

 

(INCLUDES DISCUSSIONS REGARDING THE NEW DIETARY SUPPLEMENT HEALTH & EDUCATION ACT, AS WEII AS A SPECIAL HYPOTHETICAL CORPORA TE BOARD MEETING REGARDING A PROMISING NEW NUTRACEUTICAL FOR BREAST CANCER)

November 15, 1994
The Waldorf-Astoria, New York City

 

Speakers include:

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

Bernadine P. Healy, M.D., former Director, National Institutes of Health

Louis Lasagna, M.D., Dean, Sacker School of Graduate Biomedical Sciences, Tufts University

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

 

BOARD MEMBERS: THE FIRST NUTRACEUTICAL CORPORA TION

OLIVER ALABASTER, M.D., Vice President & Scientific Director, The Cancer Foundation of America, Director, Institute for Disease Prevention, George Washington University, Washington, DC

NANCY M. CHILDS, Ph.D., Professor, Food Marketing, St. Joseph's University, Philadelphia, Pennsylvania

WILLIAM J. CURRAN, J.D., LL.M., S.M.HYG., Frances Glessner Lee Professor, Legal/ Medicine, Harvard Medical School, Boston, Massachusetts

STEPHEN L. DeFELICE, M.D., Chairman, The Foundation for Innovation in Medicine, Cranford, New Jersey

GRANT W. DENISON, JR., President, Consumer Products, G. D. Searle & Co., Skokie, Illinois

ENRIQUE J. GUARDIA, PH.D., Group Vice President, Technology, General Foods, USA, White Plains, New York

BERNADINE P. MEALY, M.D., former Director, National Institutes of Health, Washington, DC

LOUIS LASAGNA, M.D., Dean, Sackler School of Graduate Biomedical Sciences, Tufts University, Boston, Massachusetts

ROBERT J. LEVINE, M.D., Professor of Medicine, Yale University School of Medicine, New Haven, Connecticut

STEPHEN H. McNamara, ESQ., Hyman, Phelps & McNamara, P.C., Washington, DC, and former Associate Chief Counsel for Food, FDA

LAURENCE G. POLI, MBA, Director of Executive Education, Pharmaceutical Marketing Program, St. Joseph's University, Philadelphia, Pennsylvania

JERRY E. SILVERMAN, R.Ph., President, BIMARK Inc., Englewood, New Jersey

JUR STROBOS, M.D., Director of Policy Research, Food and Drug Administration, Rockville, Maryland

JAMES S. TURNER, ESQ., Swankin & Turner, Washington, DC

 


 

Nutraceutical Update: The Impact of the Nutrition Labeling and Education Act's Approach to Health and Medical Claims

September 28, 1993
The Waldorf-Astoria, New York City

 

Program

 

Nutraceutical Overview

Moderator, DeFelice

The Emerging Role of Nutraceuticals in Medicine, Goldman

Food and Pharmaceutical Industry Survey Regarding Attitudes and Activity, Childs

Q&A

The Intent of the Nutrition Labeling and Education Act, Curran

Recent Actions by Congress and the FDA Regarding Dietary Supplements and Herbal Remedies Claims, McNamara

Panel Discussion and Audience Q&A

Points of View Regarding Impact on Research. Discovery and Safety

Food Industry, Guardia

Academic Food Scientist, Lachance

Academic Medicine, Lasagna

Consumer, Carper

Q&A Break

Patient and Potential Patients, DeFelice

Panel Discussion & Audience Q&A

 

Conference Participants

Jean Carper, Author, "The Food Pharmacy" and "Food - Your Miracle Medicine", Washington, DC

Nancy M. Childs, Professor, Food Marketing Saint Joseph's University, Philadelphia, PA

William J Curran, J.D., LL.M., S.M.HYG., Frances Glessner Lee Professor, Legal Medicine, Harvard Medical School Boston, MA

Stephen L. DeFelice, M.D., Chairman, The Foundation For Innovation In Medicine Cranford, NJ

Peter Goldman, M.D., Professor, Health Science, Department of Nutrition Harvard School of Public Health, Boston, MA

Enrique J. Guardia, Ph.D., Vice President, Scientific Relations Kraft General Foods, Inc., White Plains, NY

Paul A. Lachance, Ph.D., Professor & Chairman, Food Science Department Rutgers University, New Brunswick, NJ

Louis Lasagna, M.D. Dean, Sackler School of Graduate Biomedical Science, Tufts University, Boston, MA

Stephen McNarnara, Esq., Hyman, Phelps & McNamara, P.C., Washington, DC

 


 

A COMPARISON OF THE U.S., EUROPEAN & JAPANESE NUTRACEUTICAL HEALTH AND MEDICAL CLAIM RULES

January 13 -14, 1993
The Waldorf-Astoria, New York City

Proceedings of this conference were published in Regulatory Affairs, Vol. 5, Summer 1993

 

PARTICIPANTS

1. Lyn Ciocca, The Foundation for Innovation in Medicine, Cranford, NJ

2. William J. Curran, J.D., LL.M., S.M.HYG., Frances Glessner Lee Professor of Legal Medicine, Harvard Medical School, Boston, MA

3. Stephen L. DeFelice, M.D., Chairman, The Foundation for Innovation in Medicine, Cranford, NJ

4. Victor L. Fulgoni, III, Ph.D., Vice President, Nutrition, Kellogg Company, Battle Creek, Ml

5. Tadayasu Furukawa, Ph.D., President, Nutri-Quest, Inc., St. Louis, MO

6. Nicholas Hall, President, Nicholas Hall & Co., Essex, United Kingdom

7. Paul A. Lachance, Ph.D., Professor & Chairman, Rutgers University, Food Science Department, New Brunswick, NJ

8. Louis Lasagna, M.D., Dean, Sackler School of Graduate Biomedical Science, Tufts University, Boston, MA

9. Stephen H. McNamara, Esq., partner, Hyman, Phelps & McNamara, P. C., Washington, DC

10. Abbey S. Meyers, Executive Director, National Organization for Rare Disorders, New Fairfield, CT

11. Herbert F. Pierson, Jr., M.S. Ph.D., Pharmacognocist/Chief Consultant, Preventive Nutrition Consultants, Inc., Woodinville, WA

12. Gerard Pilley, Ph.D., Member of the French National Council for Pharmay, Paris, France

13. Richard S. Rivlin, M.D., Chief Nutrition Service, Memorial Sloan-Kettering Cancer Center; Professor of Medicine and Chief Nutrition Division, Cornell Medical Center, New York, NY

14. Hercules A. Segalas, Managing Director, Paine Webber Inc., New York, NY

15. Michael D. Young, M.D., Ph.D., Corporate Director, Regulatory and Clinical Development Worldwide, The Procter & Gamble Company, Cincinatti, OH

 

A COMPARISON OF THE U.S., EUROPEAN AND JAPANESE NUTRACEUTICAL HEALTH AND MEDICAL CLAIM RULES

Discussions and Recommendations for the U.S.

A nutraceutical is any substance that can be considered a food or part of a food and provides medical or health benefits, including the prevention and treatment of disease. Such products range from traditional foods, isolated nutrients, dietary supplements and diets to genetically engineered "designer" foods, herbal products and processed foods such as cereals, soups and beverages.

The Foundation coined the term nutraceutical to [a) give an identiy to a new health sector that offers enormous health and medical benefits to the consumer, and (b) to encourage the creation of a new regulatory category. This conference will address the U.S., European and Japanese nutraceutical systems and will consider recommendations by both the panel and the audience regarding ways to encourage the establishment of a much needed vigorous research and development oriented nutraceutical system in the United States.

The Foundation will present its own recommendations regarding a new nutraceutical regulatory category as an addition to existing ones, where a sponsor can, at costs generally substantially lower than those associated with pharmaceuticals and food additives, obtain an exclusive health or medical claim. The rationale is based on the economic principles which led to the highly successful Orphan Drug Act.

As part of the program, the case method will be used regarding designer foods, plant and animal dietary supplements, processed foods - cereal and a food additive. Audience input will be emphasized. A summary of the conference, including the recommendations for a new regulatory approach, will be sent to appropriate parties including attendees.