The Pharmaceutical Journal
Vol 269 No 7216 p403
21 September 2002

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World Congress of Pharmacy and Pharmaceutical Sciences summary

Aspects of herbal medicines regulation in Europe and the United States

A session on 4 September, organised by the Medicinal and Aromatic Plants Section of FIP, focused on regulatory and legislative aspects of herbal medicines in Europe and the United States.

Classification problems

Opening the meeting, Professor Robert Anton, Louis Pasteur University, Strasbourg, France, discussed some of the problems in deciding whether to classify certain traditional medicinal plants, fortified foods (foods with added with minerals, vitamins and botanical extracts) and dietary supplements as "food supplements" or "phytomedicines". Many of the former are packed in elegant dose forms leading people to believe they are the latter, he said. The regulations could not always be applied. He cited the example of kava which was recently linked with hepatic toxicity. In Pacific island communities, kava drug is considered to be a food, and is used recreationally as a drink. A total ban is unlikely to be observed. There is also the problem of dealing with interactions between foods and drugs (for example, grapefruit interacts with cholesterol-lowering drugs, antihistamines, psychiatric medications, and others). "There could be a case for classifying the fruit as a medicine under these circumstances," said Professor Anton.

Professor Anton added that there were difficulties in classifying products being sold cross border through the internet.

UK regulation

Linda Anderson, Medicines Control Agency, UK, outlined the regulation of herbal products in the UK. She reviewed the origins of marketing authorisations and of exemptions from licensing of medicinal herbal products under the Medicines Act, 1968. The term "herbal product" is restricted to plant material, entire or in part, and excludes derived chemical constituents. Most of the licensed herbal products have licences of right and relate mainly to minor, self-limiting conditions. Recent concerns about the use of toxic Aristolochia species in traditional Chinese medicine and drug/herbal interactions with St John's wort illustrate weaknesses within the current system. Quality and safety issues arising from the use of the wrong plant, the right plant but toxic species, the presence of contaminants such as fungicides, insecticides or micro-organisms and deliberate adulteration with medicaments such as warfarin or steroids, exist throughout the EU.

Harmonisation of requirements for safety, quality and efficacy will result from the European Commission's adoption of proposals for a new directive on traditional herbal medicinal products which are intended for use in minor conditions. Evidence of efficacy will be bibliographic and based on 30 years use within the EU and "Good Manufacturing Practice" will be necessary. Products will be licensed for oral, external or inhalation use.

The UK Department of Health is currently considering registration of herbal practitioners and the UK Medicines Control Agency has set up the Ethnic Medicines Forum to review the herbal ingredients of traditional Chinese and Ayurvedic medicines in order to strengthen controls on potentially toxic ingredients in unlicensed medicines. These initiatives link with the Government's intention to ensure public access to both a wide range of safe, high-quality products and to accurate information, like that provided in Herbal Safety News on the MCA website.

Dietary supplements in the US

The regulatory aspects of dietary supplements and phytopharmaceuticals were described from an American perspective by Dr Lana Dvorkin, Massachusetts College of Pharmacy and Health Sciences, Boston. She told the audience that this expanding product group is currently regulated under the US Dietary Supplement Health and Education Act 1999. Regulation falls to the Food and Drug Administration with the monitoring of advertising being the remit of the Food Trade Commission. Dr Dvorkin defined dietary supplements as "preparations that contain vitamins, minerals, herbs etc, in addition to a normal diet". These products are for oral administration and are labelled as dietary supplements. Before marketing such a product a manufacturer must submit a Health Claim Statement to a federal public health officer, giving 30 days notice of intent. The statement must incorporate the intent to diagnose or treat a specific disease and state relationship with the disease or condition. The effect on the disease may be implied within the product name. References must be cited relating the product and the condition. Nutrition Support Claim Statements must specify effects on structures of the body and labelling must include substantiation. In all cases the active ingredients must be stated on the product label. Product quality rests with each producer. Food Industry GMP is a requirement and covers packaging and storage as well as product integrity and quarantine arrangements. If any product is adulterated or presents a risk to the public it can be withdrawn by the order of the Secretary of Health and Human Services. Dr Dvorkin suggested that a consideration for the future would be to treat all herbals as if they were new drugs on the market.

European legislation

In a presentation entitled "European regulation of herbal products in Europe", Barbara Steinhoff, Bundesverband der Arzneimittel-Hesteller, Bonn, Germany, referred to the setting up of the Herbal Medicinal Plants Working Party by the European Agency for the Evaluation of Medicinal Products Medicines Evaluation Agency in 1997. This group has prepared new regulatory guidelines on quality, safety and efficacy and adapted existing ones as well. "This work was much appreciated," said Ms Steinhoff, adding that a number of other initiatives have been made by European bodies with the aim of harmonising regulations in the EU.

Importance of controls

Professor Jenö Bernáth, Department of Medicinal and Aromatic Plants, SZI University, Budapest, outlined the importance of applying strict controls on the way in which medicinal plants are harvested and processed because such activities have direct effects on the quality of the active ingredients extracted. The features of "Good Agricultural Collection Policy" for starting materials of herbal origin were explained. Professor Bernáth acknowledged that there might be difficulties in enforcing this policy for species collected in the wild, but he thought that much could be gained by applying it to cultured medicinal plants.
— Contributed by Dr Steven Kayne and Ian Caldwell.