Outlining the regulatory environment in the UK, Ms Penny Viner (director, UK Health Food Manufacturers' Association) said that there were four different legal categories of herbs: herbal remedies with a product licence, which could be prescription only, pharmacy only or general sale list medicines; herbal remedies exempt from licensing; herbal products marketed as food supplements; and herbal products marketed as cosmetics.
Depending on issues such as claims, presentation and dosage, a single substance could be a food or a medicine. Echinacea, for example, could be marketed as a fully licensed product or as a medicine exempt from licensing, garlic as a food or medicine, and saw palmetto as a food, a medicine exempt from licensing, or potentially as a fully licensed product.
For industry, there were problems with the current situation in that there were stringent requirements and high costs involved in obtaining a product licence. And, although the other three categories of herbals allowed a way round this, there were problems with each one, Ms Viner said.
Herbal remedies exempt from licensing were those compounded and supplied by herbalists, which consisted only of dried, comminuted or crushed plants sold under their botanical name with no instructions as to their use. Intended to give herbalists the flexibility to prepare their own herbs for individual patients, exempt preparations could not be produced in quantity or sold under a brand name. In practice, however, this situation was open to misuse, and the UK market was full of these products, although they would not exist forever. Marketing a herb as a food or a cosmetic represented other possibilities, but the claims that could be made in both cases were limited.
A huge number of products occupied a borderline area, Ms Viner said, and as a result of a complaint that the UK was not entirely abiding by the law, the Medicines Control Agency (MCA) was looking into the classification of these borderline products. In addition, the MCA could use its new statutory powers, introduced under the Medicines for Human Use Amendment Regulations 2000, to re-classify herbal products as it saw fit. If those products marketed as foods had little or no nutritional value - and some herbal products did not - the MCA would be likely to consider them to be medicines, and manufacturers would have to obtain a full product licence or remove them from the market.
The industry was therefore proposing a new category for herbals, which would allow a product to be marketed with appropriate information on its indications and with the necessary regulatory control to assure quality and safety. Supported by all the major industry associations, this proposal involved a simplified registration procedure within medicines law - a third legal category was not envisaged - which offered sufficient flexibility to cover the spectrum of products on the market, while leaving legitimate nutritional products unaffected. The UK regulatory authorities were currently considering this proposal in conjunction with the possibilities offered by an enabling European directive for traditional use of medicines, which could also provide a framework allowing member states to develop national rules where appropriate, Ms Viner concluded.
According to Mr Michel Horn (president, Belgian Trade Association, NAREDI), the situation in Belgium had been resolved by the passing of the Belgian Herbal Law in 1997. This regulated herbs under food law. The law had been strongly challenged by pharmacists, he said, because products sold under food law could be sold in any retail outlet. Pharmacists had a monopoly on medicines and it would have been to their advantage had herbal products come under medicines law.
The law included a list of 365 herbs that could be sold as foods and there was a further list of toxic herbs which could not be sold. Of the 365, 100 were under scrutiny for possible toxic effects. Notification to the ministry of health was necessary before marketing any herbal product. The composition of the product had to be justified, proof had to be provided that it was manufactured according to good manufacturing practice (GMP) standards and the manufacturer had to include a label and any proposed advertising material. In the future, sellers of herbal products would have to be qualified according to an accredited programme.
In Germany, almost all herbals were medicines, Mr Norbert Pahne (managing director, German trade association, VRH) said, although many were registered according to a "simplified registration procedure." This procedure had arisen as a result of the German medicines law of 1978 in which all medicines on the market at that time had to be assessed and re-registered.
However, the system for doing this was so slow - and for herbs the required efficacy data did not always exist - that in 1994 the scope of the law was widened, such that preparations with a long history of use could be registered according to a simplified procedure. These "traditional use" products included many herbs, and about 1,700 of these had now been registered.
The other routes to registration of herbals in Germany were as prescription medicines, in which case robust clinical trial data were needed, or as over-the-counter medicines using what was known as a standard authorisation procedure, which cited official monographs as "evidence". However, only products on the market before 1978 and containing prophylactic or mildly effective herbs were regarded as "traditional use" products. These could also be registered as medicines. Few herbals were foods. Foods had to be presented as foods - not pharmaceutical products - and could not make medical claims.
An important issue to the industry in Spain was the channel of distribution for herbals, Mr Albert Sala (board member, Spanish Trade Association, AFEPADI) said. There were two categories of herbs in Spain: medicinal herbs, which legally could be sold only in pharmacies, and phytotraditional products, which could be sold in other outlets.
However, there was a problem in distinguishing between medicinal herbs and traditional products. There were also products containing mixtures of herbs with other ingredients, which did not fall into either category. Moreover, in practice, herbalists and health food shops actually sold all kinds of herbs - both medicinal and traditional.
What the industry wanted, Mr Sala said, was the freedom to sell herbals outside of pharmacies and to be able to make claims for their use. The industry did not want herbals to be categorised as medicines because that meant that they would be restricted to pharmacy only sale, and it was hoped that they would be classified either as foods or as a special category.
Special legislation for herbal products had existed in Sweden since 1978, according to Mr Ake Farnlof (president, Swedish trade association, Halsobranschens leverantorforening), and in 1993 they were classified by the regulatory authorities as medicines.
Earlier legislation had not allowed claims for herbals, but current regulations allowed for 64 claims to be applied to particular products. Thus, both garlic and echinacea could make a claim for "traditional use for soothing symptoms of coughs and colds" and Ginkgo biloba for "treatment of prolonged symptoms in elderly persons such as failing memory, dizziness and tinnitus."
More than 100 herbal remedies had now been registered as medicines by the Swedish medical agency, and all these products could make claims. However, huge "grey areas" still existed, including the 200 or so natural products that had been regulated according to older legislation, and a number of products marketed as foods, for which no claims could be made.
In Italy, a proposal for a new legal category for herbals was currently being considered by the government, said Mr Josef Hasslberger (board member, Italian trade association, Fedur Salas). If this law was passed, herbals would be neither foods nor medicines.
There was a long tradition of herbal use in Italy and herbs were available in both pharmacies and non-pharmacy outlets. Those herbs with pharmacological activity were licensed as medicines and available in pharmacies only, while non-medicinal herbs, for which there was a large market, were channelled through outlets known as herborists.
The new proposals also stated that all retailers of the "new category" must either be pharmacists or have a diploma (which involved three years of study at university) in herbal techniques. Pharmacists would not have exclusive rights to selling these "new category" products and the law, if passed, would enable the continued supply of herbal products through herborists, although they would have to be qualified.
Mr Peter van Doorn (vice president, Dutch trade association, NPN) described the situation in Holland as simple in that herbals could be either foods or medicines. Most were foods, which were sold mainly through drug stores, with only a small amount being sold in pharmacies.
However, the situation was more complex than it seemed in that there were new regulations for foods, which covered issues of safety and claims. In terms of safety, there was now a negative list of herbs which were considered to be too toxic to be sold as foods. A list of allowable health claims had also been developed. Although "splitting hairs," the statement "promotes blood flow" was considered to be a health claim, while "promotes the production of white blood cells" was a medicinal claim. "Breathe more freely" was judged to be a health claim, while "breathe freely" was a medicinal claim. "Used for inner anxiety" was a health claim and "for difficulty in concentrating" a medicinal claim.
The current situation did not please everyone, Mr van Doorn said, and preparatory work had been done on the possibility of registering herbs as medicines. The attitude of the Dutch regulatory authorities was to wait for European legislation, but there was need in the meantime to protect public health, he said. "The world is changing. Foods are increasingly taken for health as well as nutritional purposes and the separation between foods and medicines is eroding."
Summing up the day's discussions, Mr Anthony Bush (chairman, European Federation of Associations of Health Product Manufacturers) asked whether it was possible to develop an EU solution in the short term. Could all herbs be categorised as medicines or could they all be classed as foods, or was a different category required? Legal classification had implications for channels of distribution in that in some EU countries, medicines - whether over-the-counter or prescription - could only be sold in pharmacies, and the industry wanted herbals to be sold in a wider range of outlets.
It was difficult enough to have a countrywide solution. However, harmonisation was not necessarily about proposing new legislation, but about bringing the legislation of different countries closer together. The first step was for each country to develop its own solutions and this was happening already. Some aspects of some countries' solutions would emerge as better than others, but there were underlying strands common to all countries' approaches. What was needed was a framework to build on. Without existing legislation it was not possible to have harmonisation, Mr Bush concluded.