What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?

Abstract

Background In 2011 there was a strengthening of European Union (EU) legislation on the licencing of herbal products which, in the UK, resulted in the introduction of the Traditional Herbal Registration (THR) scheme. This scheme sets out standards for the safety and quality of herbal medicines and includes the provision of information to the customer on the safe use of the product. The aim of this study is to replicate a survey undertaken in 2011, prior to the implementation of the THR scheme, and evaluate the impact of this scheme on the information provided with herbal products bought over-the-counter. Methods We undertook a survey on 5 herbal products commonly available over-the-counter (St John’s wort, echinacea, Ginkgo biloba , Asian ginseng, garlic). The information was searched for key safety messages identified by the National Center for Complementary and Integrative Health (NCCIH). We also explored the presence of risk of harm information. Results We recorded a rise in the number of products registered with the THR scheme (37% in 2016 compared to 7% in 2011). We also identified a reduction in the number of products that did not contain key safety information (75% in 2011 compared to 20% of products obtained in 2016). Risk of harm information was only communicated in products containing a PIL. We identified more products containing frequency of risk of harm information but this was not statistically significant. Conclusion The introduction of the THR scheme appears to be associated with an increase in the provision of information about key safety messages on the safe use of herbal products. However, it is important to note that at least half of the products on the market that are not included in the THR scheme do not contain any information about their safe use; this includes information about precautions, interactions and side effects. The use of NCCIH herbal monographs replicated the methods used in the previous study; we recognise that the use of a different resource might effect the appraisal of the information provided. We also acknowledge that surveying presence of information does not assure that the latter is effectively communicated to patients, for which a close textual analysis would be required. While it is promising that more information is available after the introduction of the THR scheme, the public needs to be informed about ways to optimise safe use of all herbal products.

Herbal Medicine Classification: Policy Recommendations

“…In line with the THR scheme, in addition to performing quality and safety checks, "plausible efficacy" based on evidence of longstanding use and experience is sufficient to prove the product's efficacy. A study that evaluated the impact of the THR scheme in the UK prior to and after its implementation revealed that an increase in the quality of information provided with HMs was achieved (18). As the THR scheme is associated with appropriate pre-marketing evaluation, and more complete information than the dietary supplements classification, it is proposed that in addition to the choice of applying for a product license of the type needed to manufacture "conventional" products and providing evidence of clinical efficacy, the THR scheme should be implemented in the Kuwaiti DRA (Figure 1).…”

Botanical ingredients: Intakes, regulations, risks and attitudes

“…HM are regulated through the Directive 2001/83/EC. This Directive sets out requirements for registration of HM to ensure maximum consumer protection including the following: meeting standards of quality and safety and providing sufficient evidence of traditional use (2001/83/EC) (Dickinson et al 2019). Following the publication of this legislation, the Traditional Herbal Registration (THR) Scheme was set up by the UK MHRA, which sets out standards for the safety and quality of HM and includes the provision of information to the customer on the safe use of the product (Dickinson et al 2019;MHRA 2019aMHRA , 2019b.…”

“…Following the publication of this legislation, the Traditional Herbal Registration (THR) Scheme was set up by the UK MHRA, which sets out standards for the safety and quality of HM and includes the provision of information to the customer on the safe use of the product (Dickinson et al . 2019; MHRA 2019a, 2019b).…”

In vivo Evaluation and in silico Prediction of the Toxicity of Drepanoalpha Hard capsules

“…Indeed, plant extracts can be very effective therapeutically, but some can reveal themselves to be toxic with a risk of serious poisoning (Chanda et al ., 2015; Ngbolua et al ., 2011a, b; Izzo, 2004; Whitto et al ., 2003); moreover, mid-term to long-term toxicities represent particular risks as they are hardly detected by tradipraticians (Williamson et al, 2015). In the European Union, a safe use, correctly documented over a sufficient time, is considered to yield a plausible indication of innocuity, and forms the basis for marketing a traditional herbal product (Dickinson et al, 2019; HMPC, 2018). However, in many traditional medicines, and especially in developing countries, the use and safety of herbal products is hardly documented.…”