The Neutraceutical Revolution

An interview with Stephen L. DeFelice, M.D. on The Neutraceutical Revolution and the hidden medical miracles in everyday food.

| December 2000/January 2001

The Neutraceutical Revolution: the hidden medical miracles in everyday food.

From the pages of the newspaper to your grocer's aisles, neutraceuticals are everywhere you turn: eggs enriched with omega-3, margarine that claims to lower cholesterol, and breakfast cereals packaged as multivitamins. In addition, there are supplements — a dizzying bevy of pills, tinctures, oils and teas that claim to eradicate pain, boost energy, make us smarter and ward off cancer.

The Neutraceutical Revolution: A panacea or Pandora's Box? The promises are alluring, but the claims are unsubstantiated, the industry is underregulated, and the consequences of unchecked use can be alarming. Ephedra, or ma huang, a stimulant found in nonprescription herbal weight-loss supplements, has been associated with heart failure, stroke and psychosis. A popular and well-documented remedy for depression, St. John's wort inhibits the effectiveness of antiviral drugs such as protease inhibitors, which are prescribed in the treatment of HIV and AIDS. For even the most savvy consumers, the neutraceutical kingdom is a jungle, rife with contradictory evidence.

Stephen L. DeFelice, M.D., founder and chairman of the Foundation for Innovation in Medicine (FIM), is both a long-time advocate of neutraceuticals and a critic of the industry. His interest in medical research and discovery stems from his study of carnitine, a substance that occurs naturally in the human body and can be found in meat and dairy, as well as on the shelves of any health food store. As DeFelice attempted to acquire corporate sponsorship for the study, he found that corporations were loath to back natural substances, preferring instead to finance the development of synthetic drugs that could be patented.

In 1991, DeFelice drafted the Neutraceutical Research and Development Act (NREA) to promote the research of neutraceuticals. The NREA would allow companies that invest in clinical research to make health claims and obtain exclusivity on those products. At present, under the Dietary Supplement Health and Education Act of 1994, supplements may bear claims that the products affect the structure or function of the body. They may not, without Federal Drug Administration (FDA) review, claim to prevent, mitigate, cure, treat or diagnose disease. DeFelice's hopes for the Neutraceutical Research and Development Act (NREA) are based on the success of the Orphan Drug Act, which provides incentives to the manufacturers of drugs for rare diseases. Rep. Frank Pallone (D-N.J.) introduced the NREA into Congress October 1, 1999.

Monica J. Smith for MOTHER: First of all, could you define neutraceutical?

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