This section provides advice on using herbal medicines.
General advice to consumers
Remember that herbal remedies are medicines. As with any other medicine, you should use them with care while first ensuring they are the correct products for you. Also remember that the phrases ‘natural’, ‘herbal’ and ‘derived from plants’ do not necessarily mean ‘safe’. Many plants can be poisonous to humans, and many pharmaceutical medicines have been developed from plants using the powerful compounds they contain.
- Any medicine - herbal or otherwise - has the potential to have adverse effects (or side effects).
- Herbal medicines can also interact with other medicines you are taking. This could result in reduced or enhanced effects of the other medicines, including side effects. If you are consulting your doctor or pharmacist about your health or are about to have surgery or an operation, always tell them about any herbal medicines you are taking.
- As with all medicines, keep herbal medicines out of the sight and reach of children.
What you need to know as a consumer
Herbal medicines are medicines in their own right. As with any other medicine they are likely to have an effect on the body and should be used with care. The current weak regulation of herbal remedies in the UK has led to specific safety concerns which are also highlighted in this section.
There are three possible regulatory routes by which a herbal medicine can reach you as a consumer. These are as:
- Unlicensed herbal remedies. These products don’t have to meet specific standards of safety and quality and so standards can vary widely. In addition they are not required to be accompanied by the necessary information for you to use them safely such safety warnings and contraindications. Because this does not help the public to make informed choice or offer effective protection against low grade and dangerous products, by April 2011 all manufactured herbal medicines will be required to have either a traditional herbal registration or a product licence.
- Registered traditional herbal medicines. A simplified registration scheme, the Traditional Herbal Medicines Registration Scheme, began on 30 October 2005. Products are required to meet specific standards of safety and quality and be accompanied by agreed indications, based on traditional usage, and information for the patients on the safe use of the product. Consumers can find general advice on the operation of the Traditional Herbal Medicines registration scheme within the herbal medicines pages of this website.
- Licensed herbal medicines. Some herbal medicines in the UK hold a product licence or marketing authorisation just like any other medicine. These are required to demonstrate safety, quality and be accompanied by the necessary information for safe usage. These products can be identified by a distinctive nine number Product Licence (PL) number on the product container or packaging which is pre-fixed by the letters PL.
Are any particular groups at risk?
The safety of many herbal medicines has not been established in certain key groups, including:
- pregnant women
- breastfeeding mothers
- the elderly
Caution should therefore be taken when using herbal medicines, or giving them to someone else - particularly individuals in these groups.
- As a rule, anyone with a history of liver or kidney complaints, or any other serious health condition is advised not to take any herbal medicine without speaking to their doctor first.
Which herbal medicines have been assessed by government regulators (MHRA)?
In the Ipsos MORI report published in November 2008, 77% of adults agreed it is important that herbal medicines are regulated. Features of regulation that British adults feel are particularly important include: a check that ingredients are safe before the product is allowed to be sold (83% of all adults saying this is either ‘essential’ or ‘very important’) (Press release: Ipsos MORI report). Some herbal medicines are indeed regulated by the MHRA, and meet assured safety standards. These are licensed and have a PL (or Ppoduct licence) number on their labels. In 2005, the MHRA also launched a new registration scheme for herbal medicines - the Traditional Herbal Registration Scheme (THR) - under which herbal medicines have to be made to specific standards of safety and quality. These products have a THR number on their labels.
- A herbal remedy without a PL or THR number on its label is unlicensed and has not been assessed by the MHRA, therefore nothing is known about its safety, quality, or any potential side effects
Companies with existing unlicensed herbal medicines on the market have to register them with the MHRA under the THR scheme by 2011. To find out more about herbal products that have been licensed or registered since 30 October 2005, check the following public assessment reports:
Public Assessment Reports for herbal medicines
In addition, key safety information on the main herbal ingredient(s) used in these products can also be found under the Herbal safety advice section. Furthermore, herbal safety alerts are regularly published on the MHRA’s website under Herbal Safety News.
It is not generally possible for consumers to identify which unlicensed medicines are made to acceptable standards. However, there are a number of pointers, in particular from the product information, which may be indicative of poor or unreliable standards.
How can I find out about the safety of individual herbs?
Once a herbal product has had its safety and the safety of its ingredients assessed by the MHRA, it will be given a licence with a PL or THR number. As unlicensed medicines have not had their safety checked, and information for the consumer may be patchy and incomplete, the MHRA has started a new service:
- We are preparing information sheets on the safe use of individual herbs, which can be found under the Herbal information sheets section. The information will be based on herbal products that have been assessed since October 2005; this number will grow as more registrations are granted under the new THR scheme.
These information sheets aim to provide consumers with advice on specific herbal ingredients. This may help consumers identify, and avoid, any unlicensed herbal products which may come with unreliable or incomplete consumer information.
Remember that the quality, strength and usage of individual unlicensed herbal products may vary widely. This means that the MHRA information sheets can only be a broad guide to consumer information that should ideally be provided by the manufacturer of the product.
What to do if you think you have had an adverse reaction to your herbal medicine?
All medicines, including herbal medicines, may cause side effects or unwanted reactions. If you think you have had a reaction to your herbal medicine, you should discontinue using it and tell your doctor or pharmacist.
If you think you or someone else has had an unwanted or harmful reaction after taking a herbal medicine (commonly referred to as a suspected adverse drug reaction), we would like to know. This will help us give advice to other patients and healthcare professionals - and will help us make sure herbal medicines in the UK are safe.
- You can report a reaction yourself directly to us using a system called the Yellow Card Scheme.
- This can be done online http://yellowcard.mhra.gov.uk/ or by filling out a paper yellow form which is available upon request by calling 020 7084 2000.
- Alternatively, you can ask your doctor or pharmacist to report the reaction to us on your behalf.
Any information received by us will be held in complete confidence and your personal details will not be given to anyone else without your permission.
Advice for consumers when buying unlicensed herbal medicines
Consumers should be alert and cautious when buying or using unlicensed herbal medicines. Any claims that a product is safe should be backed by credible evidence.
- You should be wary of, and avoid, products making claims such as:
- The herbal remedy is "100% safe"
- Herbal remedies are "safe because they are natural"
- This herbal medicine "has no side effects"
- "Chinese medicines will not interfere with the effects of any other medicine"
- "You can avoid Chinese medicines interfering with other medicines if you take them an hour apart"
The MHRA strongly advises you not to follow any instructions for unlicensed medicines which state that you should stop taking, or change the dosage of, a prescribed medicine.
- Always consult your doctor about making changes to your prescribed medication
- Treat with caution any unlicensed herbal medicine making claims that the product can prevent, treat or cure illnesses. These claims will not have been assessed by the MHRA and could be misleading
- Be wary of any product if it is not labelled in English, or if it does not have information about safe usage or a list of ingredients.
Unlicensed herbal medicines which are similar to each other may be accompanied by different patient information. Do not assume that the medicine with fewer warnings is necessarily safer to use.
Buying herbal medicines over the internet
Again, the best advice for consumers when it comes to buying herbal medicines over the internet is to be alert and cautious. There is an international trade in poor-quality, unregulated and unlicensed herbal products. Some of these have been found to contain banned pharmaceutical ingredients or heavy metals which are poisonous. Products may also contain harmful herbs that are not permitted in the UK, and you should be aware that unlicensed herbal medicines manufactured outside the UK may not be subject to any form of effective regulation.
- Even if a product has been granted a licence in another country, there may be no guarantee that it complies with the requirements and standards of UK-regulated products.