Herbal remedies regulation

As indicated in previous sections of this chapter, there has developed a quite impressive international consensus on the general principles of bioequivalency determination for drug products regulated by agencies such as FDA. However, there are other materials used with therapeutic intent for which bioequivalency may also be a legitimate concern. Herbal remedies have, in recent years, demonstrated impressive increases in sales in many parts of the world. Other substances of natural origin have gained considerable attention for their possible curative potential. For example, shark... 

Medicines Act for relevant medicinal products, including section 7 (and consequently all exemptions relating to section 7). Relevant medicinal products are defined in the 1994 Regulations as those medicinal products for human use to the provisions of Directive 2001/83/EC apply. This broad definition includes most medicinal products. The exceptions are medicinal products for clinical trial use, products prepared in a pharmacy in accordance with a pharmacopoeial formula for direct supply to a patient, intermediate products, registered homoeopathic products, non-industrially produced herbal remedies and some products which are not medicinal products within the meaning of the Directive, but which by order have been made subject to control under the Medicines Act 1968. For products designated under such an order, the old provisions on particular patient supply are still applicable. In practice, there are very few such products. 

Herbal remedies currently are considered dietary supplements and, hence, are regulated under the same provisions as foods. Thus, to be marketed, these products do not have to meet the same stringent manufacturing or testing requirements as do patented drugs. The net result is twofold ... 

Naturally occurring substances include many phytotoxins, mycotoxins, and minerals, all occurring in the environment. The recently expanded and now extensive use of herbal remedies and dietary supplements has become a cause of concern for toxicologists and regulators. Not only is their efficacy frequently dubious, but their potential toxicity is largely unknown. 

Some dieters tried herbal remedies. These are not regulated by the FDA, and patients should check with a medical professional before taking herbal medications. 

Many traditional medicines and herbal remedies are used throughout the world and in many countries there is little, if any, regulation. In the USA alone this industry is worth a billion dollars per year. In the UK some herbal medicines are licensed, others do not require a licence when sold or supphed within particular guidelines, while yet others (such as herbal remedies) are sold as food supplements and are controlled by food regulations. In the case of the latter, no medicinal claims are allowed to be made. 

Concerns about the quality and safety of herbal remedies are justified, and there have been repeated calls for greater control and regulation (28,131,132). 

The FDA regulates both the efficacy and safety of drugs but not of foods, nutritional supplements, and herbal remedies. 

Tanacetum parthenium (Asteraceae), commonly known as feverfew, is a popular herbal remedy used a prophylactic in the treatment of migraine [88]. Studies have revealed that the action of feverfew is probably mediated by the sesquiterpene lactone parthenolide. Indeed, feverfew and parthenolide produce anti-inflammatory and antinociceptive effects in experimental animals [89]. Parthenolide is a potent inhibitor of the transcription factor NF-kB activation, a key regulator of pro-inflammatory protein production, such as cytokines, COX-2 and inducible nitric oxide synthase [90]. However, a clinical study revealed that feverfew did not provide any benefit in the treatment of rheumatoid arthritis [91]. Additional clinical studies must be carried out to explore the feverfew efficacy as an analgesic. 

Several herbal remedies are thought to be helpful in AD. Ginkgo biloba is a common herb tliat appears to increase blood flow to the brain and has antioxidant properties. The herb is available over tlie counter, but there are no standards in the United States to regulate its quality of effectiveness. No one should take tliis or any otlier herb for AD without first consulting with tlie primary care provider. When ginkgo biloba is used with otlier dru, such as with warfarin or high doses of vitamin E, tliere is a risk for increased bleeding. 

Herbal medicines, on the other hand, are regulated by the Medicine and Healthcare Products Regulatory Agency based in London. A herbal remedy is defined as... 

Traditional herbal and homeopathic remedies that are supplied as natural treatments for medical conditions or diseases are subject to regulation as drugs, for example St. John s wort. 

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