New EU rules seek to protect the health of consumers following the dramatic rise in herbal remedy usage
MY WEEKLY column on herbal remedies often leads to the question: “What brand do you recommend?” To date, my best suggestion was to try different brands, looking for one that seems to work well. That advice falls far short of the evidence-based answer I’d rather give.
Things should change after April 30th, when users of herbal medicines will have clearer guidance. That’s when the European Union’s Traditional Herbal Medicinal Products (THMP) Directive (2004/24/EC) comes into full force.
This directive means that manufacturers marketing herbal medicines must register each product as a THMP (referred to here as “herbal medicines”). Registration requires a successful application to each country’s licensing authority, which here is the Irish Medicines Board (IMB). I should point out that I am a member of an independent subcommittee that advises the IMB on herbal medicines.
The new legislation is designed to protect the health and interests of consumers across Europe, following the dramatic increase in herbal remedy usage in recent years.
Registration requires manufacturers to show evidence that the product has established traditional use for a specific condition. This means the herbal product has been used for 30 years, at least 15 of which have been within Europe.
In addition, manufacturers must prove that the product is safe when used as intended and is produced to appropriate quality standards. If approved, the registered product and packaging will provide relevant information on its approved uses and dosage, and will carry a specific product registration number.
Customers can have confidence that registered products meet the same high standards as other licensed medicines. However, traditional usage is not the same as demonstrating effectiveness.
The THMP registration scheme is voluntary, with each manufacturer deciding whether or not to apply to have their products registered in Ireland. Some herbs, for example dandelions, are used as foods and for health reasons. A manufacturer could choose to market a dandelion product as a food supplement or as a herbal medicine, depending upon the claims.
The new regulations only apply to herbal products claiming to have medicinal effects (THMPs). The legislation has no impact on collecting wild herbs, growing herbs, or purchasing herbs sold as foods or food supplements.
A number of herbs will remain available under all classifications, although some will not be permitted in food supplements because traditionally they have been used only medicinally. The IMB (imb.ie) and Food Safety Authority of Ireland (fsai.ie) have relevant information on their websites.
The legislation takes into account recent research on some herbs that shows how best to use them, the medicines and herbs they interact with and, in some cases, the recommended dosage. Yet because herbal medicines have not been registered, manufacturers could not put that information on labels.
The new legislation allows herbal medicine manufacturers to make claims about the conditions they treat and how best to use them. This information should help to inform and guide customers in their use of traditional herbal medicines.
Although it is commonly felt that herbal remedies are safe because they are natural, this is not necessarily the case. Herbs that act like drugs must be used carefully. Some herbs are not suitable for human consumption, while others should only be used below specific doses.
It is also clearly established that some herbal medicines can interact with other herbs, foods and medicines. Such interactions can make medicines more or less active, or cause a variety of side effects. Relevant information will now be placed on product labels and packaging to provide guidance for consumers.
April 30th marks the end of a lengthy transition period provided to give manufacturers time to compile evidence for their applications. The EU directive was passed in 2004 and introduced into Irish legislation in 2007.
However, the IMB reports that disappointingly few manufacturers have applied for THMP status. All products for which a registration application has been submitted by the end of April can remain on the market until the application process is completed. Products for which an application has not been submitted will no longer be available from manufacturers, but wholesalers and retailers will be allowed to exhaust existing stocks.
Registration does not limit the number of brands of any herb available. Customers interested in using a registered product should ask at their pharmacy or health shop if one is available. As time goes on, additional products will be available as they successfully become registered.
The registration process is an important step towards providing high quality herbal medicines that can be used confidently and safely.
For more information, see imb.ie
