30/04/2012 - Herbal medicine manufacturers by-passing the THR claims RPS in The Times
Herbal medicine manufacturers by-passing the THR claims RPS in The Times
The RPS has marked the first anniversary of the Traditional Herbal Medicine Registration Scheme with a letter in the Times expressing concerns that manufacturers are by-passing the Scheme and selling remedies as food supplements instead. Registering a herbal product under the THR means quality and safety are assured so both you and your patients know the dose and content on the label are what’s in the bottle.
The responsibility for defining a remedy as a food supplement lies with regulators and advisory bodies. The RPS believes they need to be much clearer about rejecting medicines masquerading as food supplements and crack down on manufacturers who are avoiding safety and quality tests on their products.
If you provide herbal medicines in your pharmacy, we suggest you recommend products marked with the THR or PL licence number.
Read the letter to The Times which was co-signed by other concerned groups:
Companies are misleading consumers and putting their health at risk by selling herbal products labelled as food supplements instead of complying with the requirements of the new Traditional Herbal Medicine Registration Scheme.
The new scheme was introduced on the 30th April 2011 to ensure the safety and quality of medicinal herbs available for self-selection by customers for self-limiting minor ailments.
The registration of a herbal product as a traditional herbal medicine guarantees it contains the stated amount of the specified herb and the absence of dangerous adulterants such as heavy metals. Registered herbal medicines must be sold with a patient information leaflet with safety information for customers.
Far less stringent safety and quality requirements apply to products sold as herbal food supplements. Some herbal products labelled as food supplements are being sold at higher concentrations than the same herbal medicine registered under the new scheme. For example, the MHRA recently reported Black Cohosh was being sold as a food supplement at 50 times the dose of the registered herbal medicine, putting consumers at risk of liver damage.
It is important to recognise that just because something is considered natural it does not mean it is safe. We believe there is a need for clear and unambiguous definitions of what constitutes a herbal medicine and a food supplement to enable consumers to make safe and informed choices about their health.
PROFESSOR JAYNE LAWRENCE, CHIEF SCIENCE ADVISOR, ROYAL PHARMACEUTICAL SOCIETY
EDZARD ERNST, PROFESSOR OF COMPLEMENTARY MEDICINE, PENINSULA MEDICAL SCHOOL
LORD TAVERNE, SENSE ABOUT SCIENCE
THE NIGHTINGALE COLLBORATION