Many traditional Chinese herbal products are on the borderline between medicines and other product categories such as foods or cosmetics. As different legal requirements apply to medicines, foods or cosmetics, 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, and by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Medicines: Herbal remedies are medicinal products. They must have a marketing authorisation (or product licence) unless they meet certain exemptions and can, therefore, 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.
Food: 'Food' includes any food, drink or food supplement that is part of the diet. Anything eaten or taken as a drink, that 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.
Cosmetic products: A cosmetic product is any substance, or preparation, that is intended to come into direct contact with the skin, hair, nails, lips or teeth, or external genital organs, and whose purpose is to clean, perfume, protect, change their appearance, keep them in good condition or correct body odour (unless done to treat or prevent disease).
The primary decision as to whether or not a product is a medicinal product is for the Medicines and Healthcare Products Regulatory Agency 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 at:
Medicines and Healthcare products Regulatory Agency (MHRA)
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Phone 020 7084 2000
Medicines and Helthcare products Regulatory Agency
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 the food 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 here. 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 (e.g. a food, food supplement or cosmetic), it is controlled by legislation enforced by the local Trading Standards Service. A brief outline of this legislation follows:
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
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. The Act is the enforcement province of Environmental Health staff and Trading Standards Food Standards Officers.
All foods and food supplements must be labelled with certain information in English. Where the food is sold loose, e.g. 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 which 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
Where the food is 'prepacked', it must also be labelled with the following:
- A list of ingredients
- An expiry date, e.g. "Best-before", followed by the date
- Storage conditions/instructions
- Instructions for use
- The name and address of a manufacturer, or a packer or seller in the European Community
- An origin indication, e.g. 'Product of China', if customers might otherwise be misled as to origin
- Where special emphasis is placed on any particular ingredient, by whatever means, or if the ingredient is a distinguishing feature of the product, the percentage quantity of that ingredient in relation to the whole product, must be indicated in the labelling
If you import cosmetic products, you are required to notify the Department of Trade and Industry (DTI) 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 they have complied with the above requirements. Cosmetic products must be clearly labelled with the following information:
- List of ingredients in descending order of weight
- Name and address of manufacturer or supplier in the European Economic Area
- Date of minimum durability or best-before date (in English)
- Warning statements and precautionary information (in English)
- Batch number or lot code
- Product function, if this is not obvious (in English)
- Quantity
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, possible side effects and classes of persons for whom the product is unsuitable, e.g. pregnant women, children or 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, e.g. invoices.
Prepacked goods, e.g. 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.
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.
Prices you display must be accurate. It is an offence to give a price indication, by any means (e.g. written or oral), that is wrong or misleading to the consumer. 'Misleading' could be, for example, if a shop omitted to include a compulsory consultation charge in the price of any goods, or if the value of any 'saving' displayed on a special offer was exaggerated.
If you trade using any name other than the name of the legal owner of the business, you must disclose the following details on your premises and on business stationery:
- The name(s) of the legal owner(s)
- An address in Great Britain where legal documents may be served on the legal owner of the business
The Trade Descriptions Act 1968 complements 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, in many cases, are false.
Many other claims, including those for the treatment of AIDS/HIV and hepatitis, could bring products under the scope of the Trade Descriptions Act.
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 Trade Descriptions Act offences.
You should think very carefully before supplying products bearing claims as to their effect (e.g. 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 Act. 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.
Whenever a trader sells goods to the public, the trader enters into a legal contract that gives the consumer certain rights.
It is illegal for traders to put up any general notice in their shop which restricts consumers' rights, for example, "no refunds", or "goods will not be refunded if the package has been opened". This is because, in law, a consumer may still be entitled to a refund in such circumstances when, for example, the goods were faulty or misdescribed.
Contravention of Trading Standards laws
Contravention of Trading Standards laws is normally a criminal offence, for which the business itself, persons controlling and directing the business and, in certain circumstances, ordinary employees can be held responsible.
You may also wish to seek advice from a trade or practitioner organisation, such as the Association of Traditional Chinese Medicine UK, the Chinese Medicine Association of Suppliers, or the Register of Chinese Herbal Medicine.
The Register of Chinese Herbal Medicine
Office 5, Ferndale Business Centre 1
Exeter Street
Norwich
NR2 4QB
Phone 01603 623 994 or 667 557
E-mail herbmed@rchm.co.uk
The Association of Traditional Chinese Medicine (UK)
PO Box 1136
Headington D.O.
Oxford
OX3 8XP
Also, please view Chinese Medical Academy UK
The Chinese Medicine Association of Suppliers
Dr Henry Lee
8th Floor
87- 90 Albert Embankment
London
SE1 7UD
This information is not an authoritative interpretation of the law and is intended only for guidance. For further information, please contact your local Trading Standards Service.