Nutraceuticals & pharmaceuticals taken together: a new health sector

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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.

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

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

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

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

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

Peter Goldman, M.DProfessor 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., MPHAssociate 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 MehrlingExecutive Vice President, General Manager, Sigma-Tau Pharmaceuticals, Inc.

Abbey S. MeyersPresident, 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