Chatting during conference are, from left, Dr. John Pinto, assistant professor of nutrition in medicine, Cornell University; Dr. Donald B. Louria, chairman of the department of preventive medicine and community health, University of Medicine and Dentistry of New Jersey, and Dr. Stephen L. DeFelice, chairman of the Foundation for Innovation in Medicine
Sunday Star-Ledger, June 24, 1984
By Angela Jones
The controversy over when a food actually becomes a drug is intensifying in the wake of an expanding health food industry and a developing interest among doctors in the use of natural substances as a medical specialty to prevent and treat diseases like cancer.
Dr. Stephen L. De Felice, chairman of the Cranford-based foundation for Innovation in Medicine, maintained during a day-long conference at the University of Medicine and Dentistry (UMDNJ) in Newark last week that strict government regulations, and limited patent protection for companies and individuals who develop innovative processes and uses for natural substances, is robbing the American public of the time-proven benefits of these largely underutilized materials.
“The promise of natural medicine is so great. There are so many things we have not touched in the plant kingdom, for example,” he said.
“This is what the public wants. There is a lot of junk out there, and by that I mean misleading and false information. We have to get rid of this and do more research.”
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Federal Drug Administration (FDA) regulations prohibit any medical claims from being made on general food items. A product is immediately thrust into the category of being a drug if such a contention is made and is subject to recall if it has not been proven to be safe, effective, and true to its medical claims.
Companies for the most part are hesitant to invest the large sums of money required on research of natural substances due to a lack of economic inventives and fear of FDA retaliation.
Although very few natural substances have been approved by the federal government for medical uses, some experts in the field believe FDA regulations in this area are outdated and overly stringent.
“The present legal system was instituted at a time when food and drugs were a bit more clearly distinguishable,” maintained William J. Curran, professor of legal medicine at Harvard Medical School.
“Today there is a greater overlap in nutritional and drug objectives. The more there is a clarity between the two, the less of a need there is for highly powerful regulation.”
Dr. Donald B. Louria of Summit, professor and chairman of the Department of Preventive Medicine and Community Health at UMDNJ, said what medical professionals are looking for is a way to “approach abnormalities before they hit the disease stage.”
He and several other researchers in the state have been testing on a small scale the use of onion oils and extracts to treat mild hypertension (high blood pressure) and hypercholesterolemia an overproduction of cholesterol by the body.
He warned however, that natural substances should not be used as a substitute for indigenous medicine, and said people should not be led to believe that “any old natural substance can keep them well.”
“We want people to take their health into their own hands but not to do it irresponsibly,’ he said. “We want to move very carefully on this.”
Stephen H. McNamara, a partner in the Washington law firm of Hyman, Phelps & McNamara and a leading authority on food and drug law, said he finds it “surprising” that the FDA prevents any information about disease prevention from being placed on certain food products such as those with lowsodium content.
“In this age of increasing interest in diet and health, people want to know more,” he said. “But there is an iron curtain there that prevents them from doing so.”
Lillian Dortch-Wright, consumer- affairs officer for the FDA, said that while the “nation’s food and safety laws are under review,’ she doubted whether any changes would be made in the area of foods for which medical claims are made.
“There is nothing in the works which will lessen the power of our food and safety laws in that a food, if it’s making a medical claim, would not have to abide by the regulations of a medical product,” she said. “It must be shown to be safe and effective and basically do what it claims to do.”
She said the ultimate “burden of proof” regarding the effectiveness of a product will always lie with the manufacturer.