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.
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 as a consumer need to know about how herbal medicines are regulated
Herbal medicines that meet assured standards
Registered traditional herbal medicines
A simplified registration scheme, the Traditional Herbal Medicines Registration Scheme (THR), 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. These products can be identified by a THR number on their label.
A certification mark has also been introduced for product labels making it easier for consumers to identify THR products.
Licensed and registered products are provided with approved patient information, which should be read before considering using the product.
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.
Herbal remedies and minor ailments
THR products are for use in minor self-limiting conditions that do not require the supervision of a medical practitioner. The permitted indications for the THR products are based on traditional usage and not on evidence of effectiveness of the product. The effectiveness of the product has not been assessed by the MHRA and therefore use in more serious conditions could put users at risk, especially if they delay seeking advice.
Unlicensed herbal medicines bought via shops, mail order, internet etc
From 30 April 2011 all herbal medicines placed on the UK market will need a THR or product licence. Consumers will still find unlicensed herbal medicines on the shelves, without written claims, after this date. The Directive included a seven year transitional period whereby products legally on the market prior to 2004 could continue to be placed on the market until 2011. These products will not be taken off the shelves, instead they can continue to be sold legally but stock can not be replenished after this date.
Consumers should be aware that standards of unlicensed medicines can vary widely and these products have not been assessed by the MHRA for quality and safety purposes. Unlicensed herbal medicines supplied by practitioners are supplied under Regulation 3 of the Human Medicines Regulations 2012 (formally Section 12(1) of the Medicines Act 1968). This is commonly referred to as the herbalist exemption and permits unlicensed remedies to be made up and supplied by a practitioner to meet the needs of an individual patient following a one-to-one consultation. The existence of this regime is greatly valued by herbal practitioners and by many members of the public. However, there are widely acknowledged weaknesses in the public health protection given by the regime. Remedies supplied under Regulation 3 are not subject to a regime of specific safety or quality requirements. There are no restrictions in terms of those who operate under the regime. Anyone - irrespective of qualifications or experience - can practice herbal medicine and, after making a diagnosis and forming a judgment about the treatment required, can make up and supply an unlicensed herbal medicine.
Practitioners are permitted to make up and supply unlicensed medicines to meet the needs of an individual patient following a consultation. Medicines made up by practitioners are not subject to a regime of specific safety or quality requirements and do not offer adequate public health protection. The MHRA is currently developing proposals for reform alongside the Department of Health (DH) led work on regulation of herbal medicine practitioners. On 16 February 2011, a DH announcement (external link) was made about the regulation of practitioners. It is intended to move to the position that only registered practitioners would be able to operate under this regime after regulation of practitioners is in place. There will be a public consultation on formal proposals for reform of herbal remedies made up by practitioners following a consultation later in 2011. The MHRA website will be updated to reflect developments.
Warning about buying unlicensed 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 license in another country, there may be no guarantee that it complies with the requirements and standards of UK-regulated products.
Be wary of any herbal medicine not licensed in the UK which is advertised as having a dramatic effect – it may well be adulterated with random quantities of potent or toxic substances
Be wary of any herbal medicine not licensed in the UK which is advertised for serious medical conditions. These unauthorised claims only serve one purpose – to persuade vulnerable groups to part with their hard earned money.
Advice for consumers if 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.
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
children
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.
Side effects and interaction with other medicines
When the MHRA receives reports that herbal medicines, for example St John’s Wort, may interact with other medicines, we look carefully at the evidence and seek the advice of the Herbal Medicines Advisory Committee (HMAC). The objective is to take a balanced and proportionate approach. The objective is to take a balanced and proportionate response which may involve adding warnings to both the herbal and conventional medicines involved. Information about potential side effects known to be associated with herbal ingredients is provided in the patient information leaflet supplied with each pack of an authorised herbal medicine.
Use of herbal medicines in patients prior to surgery
It is important for patients to discuss their herbal medicines with their doctor before they undergo surgery. In some cases it may be necessary to discontinue the herbal medicine several weeks before surgery.
Concerns have been raised that some herbal medicines should be discontinued prior to surgery. This is because it is thought that some herbal medicines could cause complications by interfering with anaesthetics, anticoagulants and other substances used before, during or after surgery. There are also concerns that some herbal medicines may themselves interfere with blood clotting and blood pressure. For example, garlic, ginseng and ginkgo have been reported to interfere with blood clotting mechanisms and may increase the risk of bleeding during surgery. Because of the limited information available on herbal medicines it is difficult to give specific guidance on when they should be discontinued prior to surgery.
Herbal remedies containing heavy metals
The adulteration of ethnic medicines with heavy metals is a significant international problem. The Agency has found, or is investigating reports of the use of, mercury, lead and arsenic in unlicensed Ayurvedic or traditional Chinese medicines. The inclusion of these metals, or salts containing them, pose a serious risk to public health. Consumers are advised to be alert to possible effects and follow the general safety advice if any are experienced whilst taking a herbal remedy.
Mercury
Inorganic mercuric salts can cause severe nausea, vomiting, abdominal pain, bloody diarrhoea, kidney damage and failure and potential nervous system effects.
Arsenic
Arsenic salts can cause severe nausea, vomiting, skin disorders, haemorrhagic gastroenteritis, cardiac arrhythmias, anaemia, jaundice, peripheral neuropathy, convulsions and paralysis.
Lead
Can cause abdominal pain, vomiting, kidney damage, peripheral neuropathy, incoordination, impairment of mental function, convulsions and coma. Surveys carried out during 2004 in the United States have shown that twenty percent of all Ayurvedic medicines in the Boston area contained potentially harmful levels of lead, mercury and arsenic. Further reports from the United States suggest that a number of patients suffered lead poisoning following the use of a range of unspecified Ayurvedic medicines. The Agency also received reports from Hong Kong in December 2004 that a product called Tik Dak Win of the Ng Chung brand was found during testing to contain high levels of lead. The Hong Kong authorities have requested the recall of the product and are advising people who have bought the product to discontinue use and dispose of any remaining tablets.
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 via Yellow Card reporting or by filling out a paper yellow form which is available upon request by calling 020 3080 6000.
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.
What do the public think about herbal medicines?
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 product 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
Herbal safety alerts are regularly published on the MHRA’s website under Herbal Safety Updates.
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.
According to mhra.gov.uk