One of the Medicines Authority’s key objectives is to protect the consumer.  To help achieve this, it wishes to inform consumers, companies and practitioners about herbal medicines that may pose a risk to human health. We hope that this section will help widen awareness of the safety issues sometimes raised by the use of herbal remedies, and in doing so, help to protect public health. 

The information provided in this section covers some general advice on potential side effects and interaction with other medicines, safety issues linked to the use of heavy metals, mis-identification of herbal ingredients and poor quality.

The main message to healthcare professionals is to report any suspected adverse reaction to any herbal remedies (Western, Ayurvedic or traditional Chinese medicines), by using the ADR report card just like with other medicines on the market. More information about this can be found in the Post-Licensing Section of the website. 

General Advice

Remember that some herbal products are medicines. As with any other medicine, you should use them with care while first ensuring they are the correct products for you. This may also apply to herbal products that are classified, for example, as food supplements or cosmetics.  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 remedies can also interact with other medicines or food 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 undergo 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.

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
• Elderly
• Patients suffering from illnesses, e.g. heart problems, kidney, liver problems, etc.
• Patients allergic to certain plants present in the herbal medicine.

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.

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.   

The Medicines Authority is currently starting the registration scheme for herbal medicinal products.  Once products are granted a marketing authorisation or a product licence, these products will include a registration number.  Therefore it will be easier to identify licensed medicinal products.  Information on the registration of medicinal products can be found in the Herbals section on the Medicines Authority website.  Products containing herbal substances or preparations may also fall under other product categories, such a foods, food supplements and cosmetics.  These are regulated by the Malta Standards Authority.

One 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 Medicines Authority 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 Medicines Authority and could be misleading
• Be wary of any product if it is not labeled 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 herbal 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 and you should be aware that unlicensed herbal medicines manufactured outside the EU 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 regulated products.