herbals: what does the future hold?

© 2001 British Nutrition Foundation Nutrition Bulletin, 26, 251–253

Correspondence: Dr Judy Buttriss, Science Director, BritishNutrition Foundation, 52–54 High Holborn, London WC1V 6RQ,UKE-mail: [email protected]

CONFERENCE REPORT

Herbals: what does the future hold?

Judy ButtrissBritish Nutrition Foundation, London, UK

The Health Food Manufacturing Association (HFMA)recently hosted a very interesting conference at theCommonwealth Conference Centre in London entitledHerbals – building for the future. This report highlightssome of the main themes emerging from the conference.

Herbal products currently fall into three categoriesunder British law, although this is likely to change as adraft EU directive develops and comes into force. Thesecategories are as follows:

(1) Herbal products sold as foods: the largest category.Direct or implied claims that a food product canprevent, treat or cure disease or adverse conditions ofmind or body are prohibited(2) Herbal remedies sold as exempt medicines (undersection 12 of the Medicines Act of 1968). Under law,such products must comply with the definition of aherbal remedy (see below) and are prohibited from dis-playing information other than the name of the con-stituents (i.e. no branding or marketing information) ontheir labels, and are prohibited from including instruc-tions about how they are to be used. These products are ‘medicines’ but as they do not have a licence fall into a void with regard to good manufacturing practiceregulations(3) Herbal products licensed as medicines, mainly viathe conversion of licences of right that came into forcefollowing the thalidomide crisis for products availablefor purchase prior to the 1968 Medicines Act. Theseproducts require marketing authorisation (a productlicence) and their production and sale fall under theMedicines Act.

The Act describes a ‘herbal remedy’ as ‘a medicinalproduct consisting of a substance produced by subject-

ing a plant or plants to drying, crushing or any otherprocess, or a mixture whose sole ingredients are two ormore substances so produced, or of a mixture whosesole ingredients are one or more substance so producedand water or some other inert substance’. The seconddraft of a proposed EU Directive, the Traditional Medicines Directive, is set to change the way exemptmedicines (category 2 above) are regarded. It is anticip-ated that this category will disappear and that a licencewill be required for the products currently covered bysection 12. Herbal remedies combined with food nutri-ents are perceived as vulnerable as they are not coveredby section 12 exemptions; as their ingredients are notentirely herbal, they require a product licence. This draftdirective is one of two recent European developmentsthat recognise that a number of Member States have dif-ficulties with the current European framework of law inthis area. For ‘well-established’ medicines, CommissionDirective 99/83EC gives in principle greater flexibilityin the use of bibliographical data to demonstrate safetyand efficacy of products. The more recent initiativefocusing on ‘traditional use’ medicines (referred toabove), which is still at draft stage, has arisen from aworking party established in September 1999 by theEuropean Pharmaceutical Committee, for which theMedicines Control Agency (representing the UK) actedas rapporteur.

Key issues highlighted repeatedly during the day’s presentations included the impact of the new directiveon the future of products currently covered by section12 of the Medicines Act (and hence currently exemptfrom licensing), the future of innovation in the industry,and the future of the use of traditional ethnic medicinesin the UK.

This new directive on ‘traditional use’ medicines issupported for a number of reasons by the UK govern-ment’s Medicines Control Agency (MCA), representedat the conference by Mr Roy Alder. For example, asindicated above, the products marketed under section12 of the Medicines Act do not carry any information

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about how the product should be used, and this doesnot best meet consumer needs. Furthermore, the qualityand safety of unlicensed products is variable and thereis a lack of consistency. There is also the potential underthe current rules for substitution, contamination andadulteration. It is difficult for the public to distinguishgood value products from bad, and current law does notsupport on-pack information provision. The aim of theMCA is to provide the public with choice and productsafety, e.g. access to a wide range of safe, high-qualityherbal remedies with appropriate information on howthey should be used.

In principle, the ‘traditional use’ directive might helpherbal medicines from other traditions enter the market,as well as European remedies for which it is not possi-ble to demonstrate ‘established’ use. However, views on the interpretation of the existing draft vary fromMember State to Member State. The UK perspective isthat the existing draft directive will not cover all theproducts currently available on the UK market. In par-ticular, there is concern that products derived fromChinese and Ayurvedic medicine traditions will beexcluded as they will not fulfil the criteria of evidenceof 30 years of traditional use within the Community(with the caveat of the potential to take into account15 years of non-EU use). Supporters of such productsare concerned that this approval would mean that accesswould be denied to ethnic minorities and practitionersin Britain who use these products as part of theirculture, which one speaker described as institutionalisedracism. The MCA supports the inclusion within thedraft directive of ‘positive’ lists (both EU and national)that detail accepted products and active ingredients.Currently, it is unclear whether the directive will gobeyond herbals and include products containing fish oilsor minerals, for example; disparate views exist amongMember States. However, the UK (MCA) recognises acase for going beyond herbals.

Safety is a crucial issue for herbal products: does theproduct on sale contain the correct plant, the correctand active form of the phytochemical, the required levelfor effect and is it free of environmental contaminants?Dr Desmond Corrigan, Chair of the Committee onHerbal Medicinal Products of the Irish MedicinesBoard, suggested that many products do not meet allthese criteria and poor quality control of this naturecould potentially affect human health. The importanceof those in the industry ordering plants by their Latinbotanical rather than their common name was stressed.For example, there are six chemo types of thyme, onlyone of which contains the ingredient thymo; there arefour types of calamus, two of which contain carcino-

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gens; and of the two types of catsclaw, only one has documented immune system effects. There is ampleopportunity for enthusiastic amateurs (wild crafters) to misidentify plants. For example, there are severalreports of digitalis being mistaken for comfrey.

Despite the current emphasis of the draft Directive on the exclusion of products derived from traditionalethnic medicines, several speakers, including DesmondCorrigan, stressed that unless they were included, theDirective would be useless, for reasons that includedsafety for the consumer, commercial opportunities formanufacturers, and cultural respect. There have beenhuman tragedies associated with poor quality control ofsuch products. For example The Fang Ji incident, inwhich over 100 women suffered total renal failure andare now facing cancer as a direct result of exposure tothe wrong plant, ordered in Belgium by its commonChinese name, rather than its botanical (Latin) name.Checking botanical identity via a microscope could haveprevented this tragedy.

In spite of recent interest in herbal remedies, themarket was described by several speakers, includingAnthony Bush, as not dynamic, there being a need forcompanies to ‘protect what you have’. He suggested thatthe market is not helped by the inability to make claimsor to provide supporting information on usage onexempt products (sold under section 12 of the Medi-cines Act), and the lack of medical endorsement for suchproducts. There is little brand differentiation, consumerconfusion (and potentially lack of confidence) and pur-ported media hostility. In the US, there has been a crisisin consumer confidence, with a big fall in the market.In Mr Bush’s view, a fundamental change is required ifit is to grow and mature. Part of this approach will, outof necessity, be enhanced interest in research and clini-cal practice that underpins the efficacy of products.

Currently, there is a lack of a research culture in theherbal industry, according to Dr Stephen Fulder. This iscoupled with a defensive position regarding regulation;lack of expertise on active ingredients, relative effec-tiveness and contra-indications; too many ‘me-too’ for-mulations; reduced innovation; and ignorance regardingstability, sourcing and variability of ingredients. Yet,research can help with regulation, exploration, expla-nation and promotion. Simon Mills discussed the con-stituents of an evidence base for herbal remedies. Hesuggested that within Europe there are likely to be threetiers of regulation in the future; (i) the licensing route;(ii) the ‘well established use’ route (99/83/EC); and (iii)the Directive on traditional use route (currently at draftstage). The organisation he represents (ESCOP) pro-vides bibliographic reviews on the available evidence for

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different herbal constituents (http://www.escop.com).Some types of data are regarded as more robust and reli-able than others. In the past, traditional-use data havebeen described as ‘lies and gossip’ by some, but may inthe future be a basis for provision of substantiating evidence of efficacy. It is not as yet clear what form thisevidence will need to take, but it was pointed out thatrecords of traditional use exist within The BritishHerbal Pharmacopaiea, and in records from other partsof the world. At the other end of the spectrum are randomised controlled trials, such as are used to estab-lish the safety and efficacy of conventional drugs.

Michael McIntyre, a herbalist, described a scopingstudy that is underway with a view to establishing stateregistration for qualified herbalists. Another practi-tioner, Dee Atkinson, made a plea for more sound andevidence-based information for the public to enablethem to make informed choices about products. All thestaff in her Edinburgh shop are now studying for a uni-versity degree in herbal medicine to help them to advisetheir customers appropriately.

In summary, the current scope under existing UK lawfor claims for herbal remedies is limited and it remainsto be seen what the future will hold.

herbals: what does the future hold?

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