Page last updated 05 July 2013
 

  

Herbal medicine shops

Find out about herbal product categories

This guidance is for England and Wales

Many traditional herbal products (such as Chinese herbal products) are on the borderline between medicines and other product categories such as foods or cosmetics. As different legal requirements apply to these different product types it is important that you are clear about the category into which your products fall. The legal requirements governing these products are enforced mainly by trading standards services and by the Medicines and Healthcare products Regulatory Agency (MHRA).

There are certain requirements for herbal remedies, which are classed as 'medicines' and must be safe. You may also be selling food items, cosmetic products, or animal products, which all have specific legal requirements.

There are further requirements in relation to claims made about the product, quantity markings, pricing, and consumer rights.

In the guide

Medicines

Herbal remedies are medicinal products. They must have a marketing authorisation (or a product licence) unless they meet certain exemptions, which allow them to be sold as unlicensed herbal medicines. To meet the terms of the exemptions, products must be solely plant-based, have no written medicinal indications for use and must not have a trade name. Herbal remedies, even if exempt from licensing, still have to be safe and be labelled in accordance with the Medicines Act 1968.

The primary decision as to whether or not a product is a medicinal product is for the MHRA to make. If you have any doubts about whether the products that you sell are medicines, or whether your products are exempt from licensing, you should contact MHRA either via its website or on 020 3080 6000.

Animal products

Strict import controls exist regarding products of animal origin. Products of animal origin include all types of meat and meat products (including poultry), all types of fish and shellfish and products made from them (like oyster sauce), eggs and egg products, wild game, honey, and dairy products. It is recommended that you only purchase food products of animal origin from reputable suppliers who can prove that the food has been legally imported into the UK via proper commercial channels. If you wish to import animal products, your local authority environmental health team should be able to advise you on the current legal situation.

If officers believe an animal product has been imported illegally into the UK, they may take it away for destruction or may ask you not to use it until you can prove it has been imported legally. A sample may also be taken of the item. You could be prosecuted for importing animal products illegally.

Some traditional remedies have been found to contain both animal and plant parts from endangered species, in contravention of legislation enforced by a number of bodies including the police. Should you have any concerns about ingredients, detailed information on endangered species is available on the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) website. CITES's main aim is to ensure that international trade in specimens of wild animals and plants does not threaten their survival. Alternatively, you could seek advice from the wildlife crime unit of your local police force or customs and excise.

Where a product is anything other than a medicine (for example, a food, food supplement or cosmetic), it is controlled by legislation enforced by the local trading standards service or, in some councils, the environmental health service. A brief outline of this legislation follows.

Food

The definition of food includes any food, drink or food supplement that is part of the diet. Anything eaten or taken as a drink, and is not a medicinal product, is a food. Many of the products you sell are likely to be legally classed as food, particularly packaged items such as herbal teas.

The Food Safety Act 1990, and the associated regulations made thereunder, governs amongst other things, labelling, ingredients and quality. The Act creates specific offences for contaminants in food, false descriptions and misleading claims such as those made for 'health' foods. .

All foods and food supplements must be labelled with certain information in English. Where the food is sold loose, such as Chinese herbs from jars, or is packed by you in the shop for direct sale to your customers, the following details are required:

  • a food name that customers can understand, indicating the true nature of the food
  • a statement, if appropriate, that the product or ingredients have been irradiated or genetically modified (see also 'Labelling of GM foods')

Where the food is 'prepacked', a number of labelling requirements need to be fulfilled - see 'Labelling of prepacked food' and 'Date & lot marking of prepacked food'.

Cosmetic products

EU Regulation (EC) No 1223/2009 on cosmetic products defines a cosmetic product as: 'any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours'. It does not apply to medicinal products, medical devices or biocidal products.

If you import cosmetic products, you are required to notify the Department for Business, Innovation and Skills (BIS) about the importation. The importer also needs to have (readily accessible for inspection) a 'product information package' giving details about the cosmetic product. If you are not importing, but are obtaining cosmetics from an importer, you should obtain reliable assurances from the importer that it has complied with the above requirements.

For further information see 'Cosmetic products'.

Claims

Any claims made about a product must be true and not misleading. This includes oral, written or pictorial claims. Particular requirements include the following:

  • any claim that a food has 'tonic' properties is prohibited
  • claims must not be made for any food or cosmetic product in relation to preventing, treating or curing human disease
  • it is a criminal offence to 'advertise' (by any written or oral statement) offering to treat, to provide a remedy for, or to give any advice in connection with the treatment of cancer
  • medicinal claims must not be made for any food or cosmetic product

Product safety

All consumer products (including food and medicines) must be safe.

Products must be sold to customers with appropriate safety information/warnings being given in English. Such information might include, for example, dosage instructions and possible side effects. They might also include classes of persons for whom the product is unsuitable - for example, pregnant women, children, and persons suffering from a particular disorder such as high blood pressure.

You are strongly advised to obtain products from reputable suppliers, and to retain any documentation that you receive from them, such as invoices.

Weights and measures

Prepacked goods, such as food/food supplements/cosmetics, all legally require an accurate quantity marking. This should typically be the weight, volume, or number of items in the package. Metric quantities must be used.

If you are selling any products loose (from bulk) by reference to weight, you must use approved weighing equipment bearing the appropriate stamp or sticker. Sales must be by reference to metric quantities.

See also 'Packaged goods - average quantity' and 'Weighing equipment in use for trade' and contact your local trading standards service for further advice and assistance with weights and measures issues.

Prices

There is a general requirement to display prices for retail goods on offer. However, if the goods can only be obtained as a result of a service (such as a consultation) there is no need to price the goods. However if your services have a 'fixed price' then it's generally considered best practice to have a price list available.

Prices you display must be accurate. It is an unfair commercial practice to give false or deceptive information about the price of goods, to omit material information about the price (such as compulsory additional charges or taxes) or if the value of any 'saving' displayed on a special offer was exaggerated.

Trading fairly with your customers

The Consumer Protection from Unfair Trading Regulations 2008 (CPRs) complement the powers and obligations in the Food Safety Act 1990. It is known that many 'therapeutic' and 'herbal' teas sold in the Far East are marketed on their ability to aid slimming, prevent medical conditions or to cure chronic illnesses. Many of these claims have no provenance, cannot be proven and are often entirely false. Many other claims, including those for the treatment of AIDS/HIV and hepatitis, could bring products under the scope of the Regulations.

Additionally, as worldwide efforts to control the exploitation of endangered species increase, manufacturers have taken to removing ingredients like tiger and bear parts from listings. They may also have removed overt references from advertisements of these products, relying on their customers' knowledge and experience as to the product's contents. These could also be considered as CPRs offences.

You should think very carefully before supplying products bearing claims as to their effect (such as slimming claims) and question these with your suppliers.

Care also needs to be taken when advertising the effectiveness of your services to avoid breaching the Regulations. For example, it may be misleading to refer to any member of staff as a doctor, unless he/she is medically qualified or holds a doctorate from a recognised university.

See 'Consumer protection from unfair trading' for more information.

Trade associations

You may also wish to seek advice from a trade or practitioner organisation, such as the following:

British Herbal Medicine Association
PO Box 583, Exeter, EX1 9GX
Tel: 0845 680 1134
Email: secretary@bhma.info

Register of Chinese Herbal Medicine
Office 5, Ferndale Business Centre, 1 Exeter Street, Norwich, NR2 4QB
Tel: 01603 623994
Email: herbmed@rchm.co.uk

Association of Traditional Chinese Medicine (UK)
314 Premier House, 112 Station Road, Edgeware Road, London, HA8 7BJ
Tel: 020 8951 3030
Email: info@atcm.co.uk

Key legislation

Please note

This information is intended for guidance; only the courts can give an authoritative interpretation of the law. Any legislation referred to, while still current, may have been amended from the form in which it was originally enacted. Please contact us for further information.

Last reviewed/updated: November 2013

© 2014 itsa Ltd on behalf of the Trading Standards Institute.

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