Regulatory issues concerning the safety, efficacy and quality of herbal remedies

Abstract

Herbal remedies and alternative medicines are used throughout the world, and in the past herbs were often the original sources of most drugs. Today we are witnessing an increase in herbal remedy use throughout the Western world raising the question as to how safe are these preparations for the unborn fetus? Many women use herbal products during pregnancy. The dilemma facing most regulatory authorities is that the public considers these products as either traditional medicines or natural food supplements. The user sees no reason for regulation. Most countries have laws concerning foods, drugs, and cosmetics, the details of which seldom clearly define to what section of the law and regulations alternative remedies belong. In most countries alternative remedies are regulated as foods, provided that no medicinal claim is made on the label. The global regulatory sector, however, is changing rapidly. The Therapeutic Goods Administration (TGA) in Australia created a Complimentary Medicines Evaluation Committee in late 1997 to address this issue, and Canada has created a new Natural Health Products Directorate in the realigned Therapeutic Products and Foods Branch in 2000. In parallel, the European Agency for the Evaluation of Medicinal Products has drafted test procedures and acceptance criteria for herbal drug preparations and herbal medicinal products. In the US, the Food and Drug Administration classifies these natural products as dietary supplements. Manufacturers must label a dietary supplement thus: "this statement has not been evaluated by the FDA [, and] this product is not intended to diagnose, treat, cure or prevent any disease." Whether these products are foods or drugs is undecided. To add complexity to this issue, most of the potential deleterious effects of natural products on the unborn may be related to hormonal effects (e.g., phytoestrogens) and nutriceutical drug interactions (e.g., St. John's Wort and antidepressants), rather than direct embryotoxicity per se. We suggest that ensuring quality of herbal products should receive immediate attention by regulatory authorities, before embarking on the more arduous tasks of safety and efficacy.

Acute and sub-chronic oral toxicity studies on the methanol leaf extract of Gnetum africanum Welw in wistar rats.

“…Herbal remedies are therapeutic products and foods made from leaves, seeds, flowers, and roots of plants [1]. Herbs and other botanicals have been used by diverse people for medicinal and dietary purposes for centuries [2], and their use has increased globally in recent years [3].…”

Toxic potentials of ten herbs commonly used for aphrodisiac effect in Turkey

“…To date, there are few scientific studies on the safety and potential toxicity of herbs, despite growing concerns over the lack of both scientific evidence and quality control data regarding the safety and efficacy of herbs (9,10).…”

Pharmaceutical Evaluation and Toxicological Quantification of Heavy Metals and Adulterated Allopathic Contents in Rawand Finished Dosage Form of Antihypertensive Herbal Products

“…The use of herbal remedies of questionable quality exposes human population to multiple risks and creates major concern for various health agencies on national and international level (Barnes, 2003). The quality of herbal products remains poor because their production is often not controlled or regulated (Rousseaux and Schachter, 2003). Therefore screening of traditional remedies for efficacy and safety has been recommended to protect public health (Calixto, 2000).…”