THE NORTH AMERICAN HERBAL ENTANGLEMENT: OF FOOD, DRUGS AND NUTRITIONAL SUPPLEMENTS

D.V.C. Awang
In the United States, almost all crude plant products are classified as "nutritional supplements" and no specific health claims are allowed for them. In Canada, plant products may be classified as either food or drug, broadly dependent upon established pharmacological effect and intended use. A number of curious and conflicting situations arise from the U.S. - Canada dichotomy, as well as by comparison with European positions. The merits of regulating "Traditional Medicines" as a category separate from conventional pharmaceuticals are advanced.

In the United States, all crude plant products - except for a few present as ingredients in some over-the-counter (OTC) proprietary preparations, such as cascara sagrada and senna - are classified as nutritional or dietary supplements. Food and Drug Administration (FDA) regulations forbid any health claims, whether they be made on a product label, package insert or in promotional and advertising material; strictly speaking even oral representation of supposed benefit at the time of sale is prohibited. As a result, consumers are deprived of useful information regarding proper application and dosage.

In April 1992, Professor Varro Tyler, the Lilly Distinguished Professor of Pharmacognosy at Purdue University spoke to the American Chemical Society national meeting in San Francisco (Tyler, 1992). Prof. Tyler expressed the view that antiquated U.S. government regulations hinder development and use of phytomedicines in the United States, depriving the American public of the benefit of natural medicines available in other countries. As do many others, Prof. Tyler regards the requirement that herbal drugs meet the stringent standards applied to conventional pharmaceuticals as unreasonable. The cost of proving a new drug "safe and effective" to the satisfaction of the FDA is widely estimated to be about $200 million U.S. Since patent protection would likely not be available, pharmaceutical concerns understandably are reluctant to invest in the development of traditional medicines. It seems quite reasonable to many that a history of long use without recognized adverse effects should be regarded as sufficient assurance of the safety of such traditional treatments. And that only "reasonable certainty" of effectiveness should apply to such herbal products, as is the case in western Europe. The question of reasonable certainty should of course be considered against the background of the particular condition for which

Awang, D.V.C. (1993). THE NORTH AMERICAN HERBAL ENTANGLEMENT: OF FOOD, DRUGS AND NUTRITIONAL SUPPLEMENTS. Acta Hortic. 332, 19-24
DOI: 10.17660/ActaHortic.1993.332.4
https://doi.org/10.17660/ActaHortic.1993.332.4

Acta Horticulturae