Contents


About the Foundation


Stephen L. DeFelice, MD


DeFelice Commentaries


NREA, Nutraceutical Research and Education Act


Television Debates
and Videos


Library


Conferences


Links


Contact Us


Board of Directors


Senator Harkin on FIM




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The Patient Always
Gets Screwed


Promising Ovarian Cancer Therapy Blocked

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 inMedicine 11th Nutraceutical Conference

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

-including-

The NREA (Nutraceutical Research & EducationAct)


EXTENSIVE SUMMARY OF THIS CONFERENCE
Written by Michael Mannion

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

See press release: NewFDA regulations published January 6th will be analyzed at FIM'sNutraceutical Conference

The American public has wholeheartedly embraced the promiseof nutraceuticals - and justifiably so. As a result, the nutraceuticalhealth 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 ofdevelopment. 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 amajor problem. The market is flooded with products for which unsubstantiatedmedical-health claims are being made. The manufacturers' claimsare not substantiated by clinical research. Americans are increasinglyaware of this situation and are beginning to express concernsabout the nutraceutical industry.

The questions that the public is asking, in combination withan awareness of the enormous medical-health potential of nutraceuticals,will inevitably lead to the birth of a clinical research-drivennutraceutical industry in which companies will conduct studiesto reasonably demonstrate the efficacy and safety of their specificproducts. This market will be a highly profitable one, generatingsufficient profits to sponsor further nutraceutical clinical research.

The major obstacle to the emergence of these true nutraceuticalcompanies is the unclear and confusing groundrules for makingmedical-health claims. For this reason, FIM has proposed the NREA(Nutraceutical Research & Education Act). The NREA was introducedin Congress on October 1, 1999 by Representative Frank Pallone(D-NJ). It is based on the successful principles of the OrphanDrug Act. See NREA page.

This conference will explore where we are today in The NutraceuticalRevolution and where we will be shortly. Included is an in-depthdiscussion of the NREA.

 

CONFERENCE PARTICIPANTS

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 Ciocca, President, Wellness Resources

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

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

FDA Representative, Invitation 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. Micati, Former 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 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 forInnovation in Medicine 10th Nutraceutical Conference

NUTRACEUTICALS & PHARMACEUTICALS TAKEN TOGETHER: A NEWHEALTH SECTOR

plus

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

Read the FIM Rationale and ProposedGuidelines 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 dietarysupplements, foods and medical foods) are being consumed togetherwith pharmaceuticals by a large percentage of the U.S. population.We must assume that to a significant degree, nutraceuticals andpharmaceuticals interact with each other, having a significantimpact on disease- either beneficially or detrimentally. Thereis little doubt that this potentially enormous new health sectoralready exists. There is also little doubt that the medical community,health industry, and federal government are not addressing thisnew explosive health sector.

FIM announces a 1 1/2 day conference which will present thecurrent information on the business and regulatory aspects offoods, medical foods and dietary supplements. Also included willbe presentations on actual or virtual clinical trials of nutraceuticalsand pharmaceuticals taken together. A medicine versus law panelregarding claims will follow each presentation. The physicianswill propose claims based on the clinical data itself. The lawyerswill propose claims based on federal law and regulations.

Products to be discussed are Benecol, Ocean Spray CranberryJuice, St. John's Wort, Intelligent Quisine, Zocor, Cispro, Prozacand Antihypertensive Pharmaceuticals.

 

The Nutraceutical Research& Education Act - NREA

In 1991 FIM published its white paper, "The NutraceuticalInitiative: 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 bea timely solution to the current state of confusion which wouldexpedite the establishment of a vigorous research-oriented nutraceuticalindustry.

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

NEWS ADVISORY

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

 

CONFERENCE PARTICIPANTS

Thomas D. Aarts, Executive Editor, Nutrition BusinessJournal

Nilo Cater, M.D., Nutrition Scholar, Center for HumanNutrition, University of Texas, Southwestern Medical Center atDallas

Lyn Ciocca, President, Wellness Resources

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

Grant W. Denison, Jr., Chairman & CEO, BioMarinPharmaceutical, Inc.

Senator Bill Frist, M.D. (R-Tenn), Chairman, SenateLabor 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, Universityof Pittsburgh

Peter Goldman, M.D., Professor of Health Science, Departmentof 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, SenateAppropriations Labor, Health and Human Services Subcommittee

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

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

Franklin C. Lowe, M.D., MPH, Associate Clinical Professorof 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, GeneralManager, Sigma-Tau Pharmaceuticals, Inc.

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

Representative Frank Pallone (D-NJ), Member, House CommerceSubcommittee 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 formerDirector, 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, announcesa one and a half day conference which will address the impactof the Nutraceutical Revolution on corporate research, developmentand commercialization of foods, dietary supplements and medicalfoods. The regulatory and commercial distinctions between thefood and drug industries continue to blur. For this reason allthree major nutraceutical categories have been included in theprogram. 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-MEDICALCLAIMS

Opinions of legal experts vs. opinions of non-legal expertssuch as corporate executives and medical authorities on the rangeof freedom regarding making health-medical claims will be presented.There is little doubt that corporate confusion regarding whatcan and what cannot be claimed has had a significant inhibitingeffect on the research, development and commercialization of nutraceuticals.Case histories will be discussed, including Pharmanex, and a paneldiscussion will be included in this segment of the program. Anticipatedfuture Congressional and FDA activities regarding health-medicalclaims will also be presented.

 

SECTION II

INFORMATION REGARDING MARKET PATTERNS AND RESEARCH DEVELOPMENTS

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

 

SECTION III

COMMERCIALIZATION: STRATEGIES FOR COMPANIES TO ENTER THENUTRACEUTICAL MARKET

This section will be divided into two parts:

A. Presentations on how specific companies are commercializingdietary supplements, medical foods and foods. A special presentationwill be made regarding botanical nutraceuticals.

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

 

CONFERENCE PARTICIPANTS

Thomas D. Aarts, Executive Editor, Nutrition BusinessJournal

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 Foundationfor 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 WorldwideNutrition Science,

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

Loren D. Israelsen, President, LDI Group

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

Louis Lasagna, M.D., Dean, Sackler School of GraduateBiomedical 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 & DrugAdministration)

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

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

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

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 NUTRACEUTICALCONFERENCE

CARDIOVASCULAR NUTRACEUTICALS: THEIR PROPER ROLE IN HEALTH& MEDICINE

 

October 14 & 15, 1997
Capital Hilton Washington, DC

The Foundation for Innovation in Medicine (FIM) announces aone and a half day conference on the proper use of cardiovascularnutraceuticals in health and medicine. A nutraceutical is a foodor parts of foods that offer medical-health benefits includingthe prevention and/or treatment of disease. Medical foods, dietarysupplements (including botanical substances) and other food ornutrient categories such as functional and designer foods areall nutraceuticals.

The positive clinical data on cardiovascular nutraceuticalsfar exceeds those of other nutraceutical categories such as anti-tumorand memory enhancer ones. Though the data on cardiovascular nutraceuticalsare highly promising and exciting, there remains a critical dilemmaconcerning their proper use regarding efficacy and safety. Whoshould receive these substances and at what doses? Should theybe given together with pharmaceuticals to enhance the efficacyand safety of the latter? What are the principles involved inmaking judgments regarding the use of cardiovascular nutraceuticals?All these issues will be addressed by a group of physician expertsin 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 Statesin which the clinical role of cardiovascular nutraceuticals willbe explored in-depth by expert physicians.

 

During the morning of the first day, topics to be coveredare:

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 Innovationin 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 BiomedicalSciences, Tufts University

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

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 AssociateProfessor, 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 & Directorof 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 andProgram Director, Clinical Nutrition Research Unit, G.l. - NutritionService, Memorial Sloan-Kettering Cancer Center

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

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

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

 


 

The Foundation for Innovation in Medicine - 7th NutraceuticalConference

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 aone 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-healthbenefits including the prevention and/or treatment of disease.Medical foods, dietary supplements and other food or nutrientcategories such as functional and designer foods are all nutraceuticals.

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

This will be the first conference in which the medical foodcategory will be explored in depth including specific medicalfood 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 Innovationin Medicine

Mark A. DeFries Chief Executive Officer, SHS North America

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

Anthony Giovinazzo Vice President, MDS Health Ventures CapitalCorporation

Peter Goldman, M.D. Professor of Health Science, Departmentof 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 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. Price President & CEO, Applied Microbiology,Inc.

Richard S. Rivlin, M.D. Professor 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 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

 


 

The Foundation for Innovation in Medicine's Sixth NutraceuticalConference

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-healthbenefits, including prevention and/or treatment of disease.

FACT: It was hoped that the passage of the Dietary SupplementHealth & Education Act (DSHEA) would lead to a research-intensivenutraceutical industry. The unfortunate conclusion, however, ofthe Foundation's last nutraceutical conference was that it wouldnot. When asked, "Who understands DSHEA?", only 1 ofthe 161 participants responded in the affirmative - a dramaticexample of (a) the confusion surrounding DSHEA and its negativeimpact on research, and (b) the urgent need for new laws to encouragesuch research.

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

FACT: A key conclusion of the fifth nutraceutical conferencewas the unanimous recognition of the critical importance of theclaims-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 nutraceuticalindustry, itself, regarding what Congress can do to establisha research-intensive nutraceutical industry that would make amajor positive impact on the lives of both the healthy and thesick. 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 participantsand attendees, along with Senators Frist and Harkin as well asRepresentative DeFazio and their staffs, can meet and mingle tocarry on the dialogue.

 

SPEAKERS

Lyn Ciocca, President and General Manager, IntraCellularNutraceuticals, Inc.

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

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

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

Senator Bill Frist, M.D. (R-TN), Senate Labor and HumanResources Committee; Chairman-Senate Subcommittee on DisabilityPolicy; 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 ResourcesCommittee; Ranking Member-Senate Subcommittee on Disability Policy;Senate Agriculture, Nutrition and Forestry Committee; RankingMember-Subcommittee on Research, Nutrition and General Legislation;Senate Appropriations Committee; Ranking Member-Labor, HHS, EducationSubcommittee; 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, Departmentof Nutrition, Harvard School of Public Health

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

Louis Lasagna, M.D., Dean, Sackler School of GraduateBiomedical 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 NutraceuticalConference

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 & EducationAct (DSHEA) to insure that the public has truthful informationregarding the benefits of nutraceuticals. A nutraceutical is afood or parts of food that offer medical-health benefits, includingprevention and/or treatment of disease. Stephen L. DeFelice, M.D.coined and defined the term "nutraceutical" in orderto create a single category which would cover a broad list ofterms such as dietary supplements, functional foods, designerfoods, hypernutritious foods, pharmafoods, certain categoriesof phytochemicals, etc. It can be a pill, drink, cereal or otherformulation. Ideally, the formulation should be the most appropriatedelivery system for the active ingredient(s) in the product.

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

FACT: There is comparatively little nutraceutical-orientedbasic-clinical research. There is, therefore, relatively littletruthful information available for educational purposes.

FACT: The proven way to generate basic-clinical nutraceuticalresearch is via a vigorous industryacademic research-orientedcomplex such as in the traditional pharmaceutical and biotechnologyindustries.

FACT: Clear regulatory ground-rules for disease-health claimsare necessary to attract corporate investment in nutraceuticalresearch.

QUESTION: Are the DSHEA ground-rules for claiming unclear andcontradictory, powerfully discouraging investment in nutraceuticalresearch?

QUESTION: Should Congress modify the DSHEA claiming ground-rulesto stimulate industrial support of basic-clinical nutraceuticalresearch?

The Foundation for Innovation in Medicine will hold a one-dayconference in Washington, DC, to review the claiming ground-rulesof DSHEA and discuss ways of improving them. Leaders from theCongress, industry, academic medicine, and other interested groupswill participate in what promises to be a stimulating and enlighteningday that includes opportunities for meeting people from all quartersof the nutraceutical world.

The session, "Physicians vs. the Lawyers" will highlightthe divergent views of medical and legal practitioners as to whatconstitutes a truthful claim. After reviewing the clinical dataon four products, the doctors will present what they considertruthful claims about these products. The lawyers will then evaluatewhether such claiming language, i.e., the truth, would be permittedunder the DSHEA. The answer? Come hear the debate!

Senator Tom Harkin (D-IA), the founder of the National Institutesof Health Office of Alternative Medicine, and Representative FrankPallone (D-NJ-6), who has submitted the Food and Dietary SupplementConsumer Information Act (HR.1951), will join representativesof various segments of the nutraceutical health community to commenton the claiming dilemma. A panel will then review and analyzethese comments, and discuss ways of improving the breadth andnature of the claiming groundrules in a way that will stimulatesubstantial increases in investment in nutraceutical research.

Three afternoon presentations will review how the food, traditionaldietary supplement, and herbal remedy industries have interpretedDSHEA, and examine the claims that companies are actually making.These will be followed by a presentation on the nutraceuticalindustry as an investment opportunity.

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

 

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 ResponsibleNutrition

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

Juanita Duggan, Executive Vice President for GovernmentAffairs & Communications,

National Food Processors Association

Senator Bill Frist, M.D. (R-TN), Senate Labor and HumanResources Committee; Chairman-Senate Subcommittee on DisabilityPolicy; Senate Budget Committee; Senate Small Business Committee

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

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

Patricia Hausman, President, NutriProse

Loren D. Israelsen, Esq., Attorney at Law

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

Robert J. Levine, M.D., Professor of Medicine, YaleUniversity 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 Foodand Dietary Supplement Consumer Information Act; Member-HouseCommerce Committee; Subcommittee on Health and Environment

Stuart M. Pape, Esq., Patton Boggs, L.L.P. (former ExecutiveAssistant 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, Centerfor 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 NutraceuticalConference

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 %-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

 

CONFERENCE PARTICIPANTS

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

Lyn Ciocca Director, Trident Group

J. B. Cordaro President, 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. Drennan President & 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 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 BiomedicalSciences, Tufts University

William E. Learnard Managing 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 Martinez Director 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. 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, NabiscoFoods Group



 

NUTRACEUTICAL RESEARCH, DEVELOPMENT & MARKETING: TIMETO MOVE FORWARD?

 

(INCLUDES DISCUSSIONS REGARDING THE NEW DIETARY SUPPLEMENTHEALTH & EDUCATION ACT, AS WEII AS A SPECIAL HYPOTHETICALCORPORA TE BOARD MEETING REGARDING A PROMISING NEW NUTRACEUTICALFOR BREAST CANCER)

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

 

Speakers include:

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

Bernadine P. Healy, M.D., former Director, National Institutesof Health

Louis Lasagna, M.D., Dean, Sacker School of Graduate BiomedicalSciences, 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 DiseasePrevention, George Washington University, Washington, DC

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

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

STEPHEN L. DeFELICE, M.D., Chairman, The Foundation for Innovationin 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 Institutesof Health, Washington, DC

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

ROBERT J. LEVINE, M.D., Professor of Medicine, Yale UniversitySchool 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, PharmaceuticalMarketing 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 DrugAdministration, Rockville, Maryland

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

 


 

Nutraceutical Update: The Impact of the Nutrition Labelingand 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 Attitudesand Activity, Childs

Q&A

The Intent of the Nutrition Labeling and Education Act, Curran

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

Panel Discussion and Audience Q&A

Points of View Regarding Impact on Research. Discovery andSafety

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 LeeProfessor, Legal Medicine, Harvard Medical School Boston, MA

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

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

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

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

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

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

 


 

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

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

Proceedings of this conference were published in RegulatoryAffairs, 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 GlessnerLee Professor of Legal Medicine, Harvard Medical School, Boston,MA

3. Stephen L. DeFelice, M.D., Chairman, The Foundation forInnovation 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, RutgersUniversity, Food Science Department, New Brunswick, NJ

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

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

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

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

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

13. Richard S. Rivlin, M.D., Chief Nutrition Service, MemorialSloan-Kettering Cancer Center; Professor of Medicine and ChiefNutrition 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, Regulatoryand Clinical Development Worldwide, The Procter & Gamble Company,Cincinatti, OH

 

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

Discussions and Recommendations for the U.S.

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

The Foundation coined the term nutraceutical to [a) give anidentiy to a new health sector that offers enormous health andmedical benefits to the consumer, and (b) to encourage the creationof a new regulatory category. This conference will address theU.S., European and Japanese nutraceutical systems and will considerrecommendations by both the panel and the audience regarding waysto encourage the establishment of a much needed vigorous researchand development oriented nutraceutical system in the United States.

The Foundation will present its own recommendations regardinga new nutraceutical regulatory category as an addition to existingones, where a sponsor can, at costs generally substantially lowerthan those associated with pharmaceuticals and food additives,obtain an exclusive health or medical claim. The rationale isbased on the economic principles which led to the highly successfulOrphan 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.