Nutraceutical Revolution Continues at Foundation for Innovation in Medicine Conference

by Michael Mannion
American Journal of Natural Medicine, V5, N7, Sept. 98

“There will be no Coca Cola, no Pfizer, no Campbells in 2010,” said Stephen L. DeFelice, M.D., chairman of the Foundation for Innovation in Medicine (FIM). “These companies will either change their nature or disappear.” Dr. DeFelice, dubbed the “Don Quixote of Nutraceuticals” by The New York Times, delights in controversial, provocative statements. He is the man who coined the term “nutraceutical,” over dinner, appropriately enough. He spoke at the FIM conference, The Nutraceutical Revolution (re: Foods, Dietary Supplements, and Medical Foods): Its Impact on the Food and Drug Industries, which was held in New York City, May 20-21, 2002.

The conference was well-attended by representatives of the food, pharmaceutical, dietary supplement, herbal, and health food industries. Attendees were eager to understand the nutraceutical revolution, and their place in it.


Nutraceutical market

How big is the nutraceutical market? Estimates vary widely. Datamonitor, a website that tracks market trends, puts it at almost $17 billion; the health food store chain General Nutrition Corporation (GNC) says it will reach $10 to $12 billion within the next few years; Dr. DeFelice estimates the market to be $250 billion in the United States alone. To back his assertion, Dr. DeFelice provided some startling numbers.

The total United States food market in 1992 was $503 billion. This far exceeded the $70 billion spent on prescription drugs and the $24 billion for over-the-counter products. Dr. DeFelice believes it is reasonable to estimate that DO% of the foods Americans consume, such as enriched foods or virtually fatless meats, are used for nutraceutical reasons (i.e., to enhance health). When these figures are combined with the fact that 100 million Americans take daily dietary supplements, a clear picture of an established nutraceutical market begins to emerge.


Potential of nutraceuticals

In his opening remarks, Dr. DeFelice said that the industry is still waiting for the first true nutraceutical company to enter the scene. The promise of nutraceuticals is enormous, but the food, pharmaceutical, dietary supplement, herbal, and health food industries have not capitalized on their potential. According to Dr. DeFelice, CEOs see only risk when they look at nutraceuticals. No one has vet stepped forward to lead any of these industries into a position to shape and dominate the multi-billion dollar nutraceutical market. However, it is certain that a nutraceutical equivalent to “Bayer” or “Microsoft” will emerge in the near future.

Dr. DeFelice stated that if the nutraceutical industry is to develop and thrive, it must be researchdriven and not advertising-driven. He emphasized the vital need for scientifically established, clinically proven data on all nutraceutical products.


Physicians under pressure

Nancy M. Childs, Ph.D., professor of food marketing at St. Joseph’s University, spoke on HMOs and nutraceutical opportunities. She indicated that profound changes are underway in American health care. According to Dr. Childs, 30 to 40 percent of Americans are disenchanted with the health care they receive. Physicians are under pressure from their patients to provide information on complementary or alternative approaches to health care.

Fortunately, today’s allopathic practitioners are struggling to catch up with this radical change in American health care. Half of American physicians now use and/ or receive complementary care. Approximately 30% of American medical schools now teach complementary medicine. The National Institutes of Health, through its Office of Alternative Medicine, is funding 10 national centers that focus on complementary medicine, including research on nutraceuticals.


Changing rules

Loren D. Israelsen, president of the LDI Group, discussed “Botanical Nutraceuticals: Corporate Examples of Science- Based Marketing.” His talk was illustrated with compelling examples of advertising for botanical products that appeared in trade publications for the health food industry. The ads showed how marketing approaches have evolved over time. At first, the product was emphasized instead of health claims for the product. One ad for a weight-loss product containing ephedra, showing a beautiful blonde woman in a bikini, was the most glaring example in a series of ads that had no scientific data to support the implied health benefits.

In 1994, Israelsen said, the Dietary Supplement Health Education Act ( DSHEA) changed the rules of the game for advertising. From that point on, the manufacturers’ claims changed dramatically. After DSHEA, health claims began to be made for products. One herbal product, HerbalProz, even used part of the billion-dollar drug Prozac in its name. Israelsen showed ads that made health claims about menopause, depression, immune function, and other conditions.

For botanicals, the Food & Drug Administration FDA) generally allows claims on structure and function ¢e.g., “Helps maintain a healthy cholesterol level”), but does not allow disease claims (e.g., “Lowers cholesterol”). This prevents manufacturers from using scientific data that supports a disease claim in their ads, even when obtained from double-blind, controlled clinical trials published in peer-reviewed journals. Studies of echinacea, Ginkgo biloba, and St. John’s wort, published in respected journals, were cited as examples.

Israelsen explained that diseases and health conditions are not identical. A botanical manufacturer cannot make valid claims, unless he or she knows which one it is attempting to treat or prevent. The differences of opinion on the issue of health claims, a key issue in the future of nutraceuticals, remains to be resolved. It is an unfortunate situation: Reliable data cannot be used to support useful products because of regulatory definitions.


Aging Americans

John P. Troup, Ph.D., vice president, Scientific Affairs for GNC, discussed his firm’s approach to nutraceuticals. Like Dr. Felice, Dr. Troup sees nutraceuticals as a consumer-driven industry. He told the audience that by 2010, 50% of the American public will be over age 50. A growing number of Americans are now focused on maintaining their health. They understand that while a long life may be appealing, getting old appeals to no one. Many Americans are trying to preserve their vitality as they age, and nutraceuticals play a large role in self care.

Dr. Troup noted that supplementation was dominant from 1950 through 1980; fortification from 1980 through 1995; and functionality in the past few years. Functionality moves beyond prevention to maintaining and improving health, and even reversing poor health. GNC-sponsored studies show that consumers want accurate information and respect strong scientific research.

Dr. Troup asserted that cardiovascular disease, weight management, cancer, immune disorders, diabetes, osteoporosis, arthritis, age-related problems, and general adolescent health are among the public’s top health concerns. He noted that while scientists and physicians look to professional publications, the public is highly influenced by the mass media, especially by reports in The New York Times and USA Today.


Growth of nutraceuticals

Rhonda Scott Wiwer, business development manager for Monsanto, spoke about the commercialization of nutraceuticals. (She was not attending as a representative of Monsanto. ) According to Wiwer, thousands of existing products can be considered nutraceuticals, such as dietary supplements and enriched foods. In addition, a number of companies produce nutraceuticals that are extensions of existing products (e.g., natural juices, acidophilus milk). New corporate ventures are being developed to deliver new brands of nutraceuticals to the consumer.

Wiwer believes the key to success in the emerging nutraceutical industry lies in research and clinical trials, increased consumer awareness, and wide media coverage.

The ability to patent products made the pharmaceutical industry possible. The lack of Patentability has inhibited the development of nutraceuticals. However, Wiwer asserted that combinations of natural compounds can be patented, allowing the creation of proprietary positions. She said that a number of’ corporations and nonprofit health groups are working together on nutraceutical enterprises; for example, ConAgra and the American Heart Association.


Marketing vs. science

Paul A. Lachance, Ph.D., executive director of The Nutraceutical Institute and professor of nutrition and food sciences at Rutgers l Unuversity, gave a talk titled “A Government-University Nutraceutical Venture.” Professor Lachance noted that the marketing of nutraceuticals was far ahead of the science of nutraceuticals. The Nutraceutical Institute, a joint partnership of the New Jersey state government and private colleges, is an exciting experiment, he noted. They are now growing botanicals and studying the complex, synergistic effects of the nutrients in these plants. His group is conducting sophisticated studies of herbs for safety, efficacy, potency, health, optimum harvest time, and other crucial factors.


Things to come

The conference featured a dozen speakers, as well as a number of panel discussions. The experts agreed that the Nutraceutical Revolution is a cultural movement, and that the Alternative Medicine Revolution is its foundation.

Dr. DeFelice told The American Journal of Natural Medicine ™, “The very tact that there is now evidence that we have a research-driven industry indicates that the big cures that no one expects will happen, will arrive about the year 2010. This is very good news.”


Michael Mannion has been a health and medical writer for over 20 years. He was formerly with the NYC Health Department and the American Cancer Society, where he was director of professional education publications and managing editor of the Society’s clinical journal. He is the author of The Pharmacist’s Guide to OTG | and Natural Remedies, Project Mindshaft, as well | as two forthcoming titles. Alternative America: Healing and the Transformation of American .Medicine and How to Help Your Teenager Stop Smoking.