Navigating Herbal Medicine Legislation

Thinking of formulating a herbal tea, or adding herbs to your new food product? Or perhaps you want to come up with the next big superfood, nootropic, functional food or supplement? Do you understand the legislation? If not, read on…

Traditional Herbal Registration

TheEuropean Traditional Herbal Medicinal Products Directive, or THMPD (Directive 2003/24/EC), came into effect on 30 April 2011. This established a regulatory approval process for herbal medicines in the European Union which meant that only herbal medicines that met EU standards of quality and safety could be granted a Traditional Herbal Registration (THR). These products did not need to be supported by clinical evidence of efficacy but did need bibliographic or expert evidence to demonstrate 30 years of traditional use for the required indication, of which 15 years had to have been within the European Union. You can find a list of products granted a THR on the Medicines and Healthcare Products Regulatory Agency Website (MHRA). A THR must be applied for to market a herbal medicine in the UK, and is granted only if a medicine is used for minor health conditions where medical supervision is not required. Manufactured herbal prodcuts which claim to treat a major condition are required to have a Marketing Authorisation (MA), which is extremely expensive. This means that on the whole, only pharmaceutical companies and larger manufacturers are able to afford to place products on the market.

Herbal practitioners are exempt from needing a THR if they themselves supply herbal medicines that they create on their premises for patients following a one-to-one consultation.

In December 2017 I stopped working with a clinic I had previously worked because I found out that the owner had not been entirely truthful about the herbal medicine and other qualifications he had purported to hold. The owner was not a qualified herbal practitioner at all! The clinic in question was also selling products which required a THR. The herbal medicines they were selling were not being created on their premises and were not being sold to patients following one-to-one consultations, they were even being sold to the general public via a third party website.

I am sure in some cases these mistakes are innocently made, but when flagged with the owner that the products required a licence, my advice was ignored and the products to the best of my knowledge continue to be sold without application for a THR.

The point here, is that it is very easy to fall foul of Herbal Medicine Legislation as legislation is still extremely unclear.You risk prosecution, and you put the lives of the public at risk.

Medicine, Borderline Product, Novel Food or Food?

If you are creating a product containing herbs, it is important to establish whether that herb is considered a medicinal product.  This needs to be established by the MHRA.  They will look at herbal ingredients and determine whether the ingredients in question have well-known pharmacological effects and whether the herbs you wish to use in your product might only be found in products that are used for medicinal purposes. 

Does your product contain a novel food? A novel food is a food ingredient that does not have a significant history of consumption within the European Union before 15 May 1997 and as such, must be approved for use on the European market and rigorously assessed for safety.  Assessment is also required for any food that has been produced using a novel production process (any production process not used before 15 May 1997) if this process significantly alters the nature of that food.  The EU provides a Novel Foods Catalogue for reference and you can check your food with the Food Standards Agency, however,  regardless of whether a novel food has been authorised previously by another company, you will still need to apply for your own authorisation. 

It does get confusing.  Whereas chia seeds, stevia and mesquite are considered novel foods, herbs such as Korean ginseng (Panax ginseng), Brahmi (Bacopa monnieri), Shatavari (Asparagus racemosa) and Gentian (Gentiana lutea)  have been used within the European Union as foods within the European Union prior to May 1997 and are not considered novel foods. 

If you go through the expensive process of putting a product to market without verification, you risk having to remove it, reformulate it and who knows if your business will survive?

Do you need help formulating your product or navigating this legislation?
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