NUTRACEUTICALS Developing, Claiming, and Marketing Medical Foods


Developing, Claiming, and Marketing Medical Foods

Edited by Stephen L. DeFelice, M.D.
Marcel Decker, Inc. New York – Basel – Hong Kong

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Based on a recent international conference, this breakthrough resource examines the present status of research on nutraceuticals — foods or food parts that offer medical-health benefits, including the prevention or treatment of disease.

Discussing medical, functional, and designer foods; dietary supplements; and other food categories, Nutraceuticals shows how current U.S. regulations make it economically feasible to conduct preclinical and clinical studies to substantiate medical claims for nutraceuticals…furnishes concise background information on the history of nutraceuticals…demonstrates the requirements for making claims regarding health benefits…elucidates European perspectives on medical foods…delineates the position of the U.S. Food and Drug Administration on nutraceuticals…explains the Dietary Supplements, Health and Education Act, and the Nutrition Labeling and Education Act…presents case histories of nutraceuticals in the medical treatment of hypertension, diabetes, and benign prostatic hyperplasia…and more.

Written by leading experts in medicine, pharmacology, law, and business, Nutraceuticals is a useful reference for food scientists; composition and nutrition engineers; biochemists; nutritionists; pharmacologists; internists; cardiologists; gerontologists; dietitians; research and development personnel, marketers, and executives in the food industry; and graduate students in these disciplines.



Foreword (L. Lasagna)



The Nutraceutical Revolution: What Is It?
S. L. DeFelice

Medical Foods
J. Strobos

FDA Regulation of “Medical Foods” — An Industry Perspective
S. H. McNamara

What Is Sufficient Evidence to Support a Health-Medical Claim?
S. L. DeFelice

Medical Foods: What Is Sufficient Evidence to Support a Health-Medical Claim?
L. Lasagna

Medical Foods: The European Approach
G. Pilley

Medical Foods, the United States Congress, and the Food and Drug Administration: A Lobbying Primer and Commentary
A. C. Martinez

Saw Palmetto Berry in the Treatment of Benign Prostatic Hyperplasia
F. C. Lowe

Cardia Salt Alternative
F. Price

Zbar as a Part of the Diabetes Regimen
F. R. Kaufman

Hypoallergenic Formulations and Medical Foods, the Neocate Product Range
M. A. De Fries

Appendix 1. Advance Notice of Proposed Rulemaking

Appendix 11. Advance Notice of Proposed Rulemaking: Extension of Comment Period



Dr. Stephen L. DeFelice coined the term nutraceuticals to describe a promising new revolution in medicine and health in which foods, dietary supplements, and botanical remedies are beginning to play a major role in the prevention and treatment of disease.

There is little doubt that the foundation for the nutraceutical revolution has been firmly established. Dietary modification has been shown to lower both blood pressure and cholesterol; vitamin E supplementation shows promise in the prevention of cardiovascular and Alzheimer’s disease and in improving immune responses; and Ginkgo biloba is reported to improve cognition and ginseng to increase feelings of well-being in diabetics. The list is impressive and continues to grow.

The category of medical foods created by Congress is extremely important since it has already begun to encourage substantial nutraceutical research. For this reason, Dr. DeFelice convened a group of experts from diverse specialties to come together to educate all of us regarding its importance. Their outstanding contributions have been compiled in this volume.

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