Elizabeth A. Smith
Drug Topics, June 15, 2002
Fueled by clinical research and consumer demand, the nutraceutical revolution is “unstoppable,” declared Stephen L. DeFelice, M.D., chairman of The Foundation for Innovation in Medicine (FIM).
DeFelice coined the term nutraceutical over a decade ago to describe any food or food part taken for health benefit. Products range from isolated nutrients and dietary supplements to genetically engineered “designer” foods, herbal products, and processed cereals, soups, and beverages. Based on that definition, nutraceutical sales tallied $86 billion in 1996, a 7.5% increase over 1995, according to Nutrition Business Journal. DeFelice estimates the potential market at $250 billion, or half the food market and 2.5 times the pharmaceutical and over-the-counter markets combined.
“The people are driving this phenomenon,” he emphasized at FIM’s 9th annual Nutraceutical Conference, held recently in New York City. Consumers are encouraged by news of clinical research conveyed to physicians and patients by the media, he said. Some 70% of practicing physicians now recommend dietary supplements, and eight of 10 physicians take vitamin E, he said. It is estimated that one third of the U.S. adult population is taking vitamin E.
According to Grant Ferrier, NBJ editor, consumers’ desire to slow aging prevent disease, and optimize health underpin the rapid 15% to 20% growth seen in the $20-billion nutrition industry, prompting mainstream food and pharmaceutical corporations to consider launching nutraceutical products.
“The medical promise is huge and immediate,” DeFelice said. “I could do a study right now on an antidepressant nutraceutical and be on the market in two years at a cost of $5 million to $10 million.” A drug would take six to 10 years and cost $200 million to $300 million to enter the market, he said.
Today, pharmaceutical companies tend to view dietary supplements as competitors, perhaps because “one good nutraceutical can wipe out the drugs,” DeFelice observed. By 2010, he predicted, corporate lines will blur as pharmaceutical-nutraceutical firms are formed to offer various products for the same ailment, such as Prozac and St. John’s wort for depression.
One concern within the industry is dietary supplement labeling. The Food & Drug Administration recently proposed new regulations clarifying what statements manufacturers may and may not make about their products. Rhonda Scott Witwer, business development manager for Monsanto, noted that different words have different meanings to different people, making the issue quite complex.
One possible solution to the current health-claims issue would be to provide two types of labeling-one for patients and another for health-care professionals, DeFelice suggested. Stephen H. McNamara, Esq., of Hyman, Phelps & NcNamara, P.C., and former associate chief counsel for food at the FDA, said occasional efforts have been made to establish special professional labeling for certain products. But those proposals may not be the best solution for consumers, he said.
Another concern in the industry is whether certain dietary supplements cross the line into medicine (see story, page 57). Antonio C. Martinez II, Esq., a government and regulatory affairs counsel, said, “The public wants more scientifically reliable information about alternative and complementary medicine.” But before patients can use natural substances therapeutically, health professionals need research instructing them how to utilize those products effectively, he concluded.