Botanical Medicine: The Need for Better Quality Research
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Herbal or botanical remedies consumption by the public is on the increase in the western world. This demand is often rooted in the belief that herbal products, being natural, are safe to take and can contribute positively to the management of disease states. This tendency of using natural products for managing illnesses is by no means new to health care [2]. While the earlier demand for herbs has been diminished due to the new advances in drug synthesis, a review of current drugs revealed a high percentage of them (about 25%) still had a botanical origin. In response to the public’s demand for a better recognition of the natural products in health care, the United States Congress established in 1994 the Dietary Supplements Health and Education Act, also known as DSHEA. According to DSHEA, dietary supplements (DS) are “intended to supplement the diet” by providing the consumer with specific nutrients including vitamins, minerals, herbs, amino acids, and others . As such, the intention of DSHEA was not to use these products for the management of disease state, but rather to use them as “supplements” to the regular diet. The US Food and Drug Administration (FDA) is the Federal agency that regulates DS products available on the US market, while the Federal Trade Commission monitors the “truth-in-advertising” claims for any misleading information in DS advertisements. Unlike prescription or over-the-counter medications, DS manufacturers do not have to submit to the FDA any safety or efficacy data prior to marketing. In fact, it is the FDA’s responsibility to monitor the safety of DS while they are being consumed by the public. The current Federal regulations require the manufacturer of DS to formulate and package them under cGMP-controlled (current Good Manufacturing Practice) environment