Why register your product as a traditional herbal registration instead of a food supplement?
Herbal products are available in various forms on the UK market. They can be a licensed medicine – either with a full standalone license or alternatively as a ‘traditional herbal medicine’. In the UK the traditional herbal registration (THR) scheme allows manufacturers of good quality herbal products to register these as medicines based on ‘traditional use’. This means that a herbal product has been used traditionally for at least 30 years. This route to market is cheaper and quicker than a full standalone licence.
This route also allows the manufacturer to make a medicinal claim on the packaging (e.g. ‘to relieve the symptoms of slightly low mood and mild anxiety exclusively based on tradition of use only’). It also shows that the herbal product has been assessed by the MHRA and is manufactured to GMP, emphasizing the quality of the product. Overall, this means that while the evidence for efficacy may be limited, the scheme provides an assurance that the product is of a good quality and safe for use.
An alternative way to bring herbal products to market without undergoing registration as a medicine is by classifying it as a ‘food supplement’. By contrast with the THR products, these products cannot make any specific medicinal health claims, however people may still buy them expecting certain therapeutic effects. Their quality requirements are generally based on food legislation, which means that these products are not subject to the same high level of legal and manufacturing scrutiny as a THR product.
While the food supplement route is often a cheaper and quicker route to market, quality is not guaranteed with these products, and you are not able to advertise any medical claims. Many food supplements have been under scrutiny in recent years, with investigations showing that they are not always what they say they are. This has certainly damaged public perception and is worth considering when deciding how to market your product.
If you would like to discuss how Fusion Pharma can support you with your THR application, or to advise on the best route to market, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
