The European Medicines Agency (EMA), which is responsible for the evaluation of medicines used within the European Union (EU), has announced that it will regularly publish consumer-friendly summaries of the findings of its Committee on Herbal Medicinal Products (HMPC) on its website. The main purpose of the HMPC is to review all available scientific data on the use of specific herbal medicines, including information on safety and effectiveness, and to issue conclusions in EU herbal monographs on how to use these medicines responsibly.
Since its establishment in 2004, the HMPC has issued more than 140 of these monographs, which include approved therapeutic uses, recommended dosages, possible adverse side effects, contraindications, and interactions with other medicines, among other information.1 The monographs cover a range of therapeutic uses, with gastrointestinal disorders, urinary tract and gynecological disorders, and cough and cold being the most frequently covered. The monographs were initially meant to help EU Member States when reviewing medicinal applications for herbal products submitted by phytomedicine companies and others in the herb industry.1
These monographs support two bases (see table below) for marketing herbal preparations as herbal medicinal products (HMPs).
The new consumer-accessible summaries will abridge the monographs, which are also published on the EMA’s website. Each summary will follow the same basic format. For example, the three-page summary on Ginkgo biloba leaf medicines, which contain a specific herbal preparation made by powdering the dried leaf or as a dry extract, includes a general description of the leaf, the HMPC’s conclusions about the uses of medicines made from the two previously mentioned preparations, proposed mechanisms of action, evidence to support their use, and possible risks associated with use.
The EMA has previously released summaries for some herbal substances, but it will now do this systematically for all newly assessed substances, as well as for previously assessed substances. The summaries are meant to complement information contained on the packages of the medicines that contain the substances and will eventually be made available in all official EU languages.1
Six new summaries were released on August 3, 2015, when the EMA announced this new feature:
- California poppy (Eschscholzia californica, Papaveraceae)
- Ginkgo (Ginkgo biloba, Ginkgoaceae)
- Comfrey root (Symphytum officinale, Boraginaceae)
- Capsicum pepper (Capsicum annuum var. minimum and C. frutescens, Solanaceae)
- Agrimony (Agrimonia eupatoria, Rosaceae)
- Mouse-ear hawkweed (Hieracium pilosella, Asteraceae)
Though millions of people throughout Europe use herbal medicines, confusion exists regarding the distinction between HMPs and botanical food supplements: the former are regulated as drugs and the latter as food supplements under different EU regulations and requirements. Simon Mills, noted author, medicinal plant expert, and secretary of the European Scientific Cooperative on Phytotherapy (ESCOP), a pan-European consortium of research experts, said the new summaries could help address this problem. “It is likely that the EMA is intent on raising public awareness of the status of herbal medicinal products, given the widespread ignorance of this category in some Member States,” Mills said (email, August 14, 2015). Mills is a long-time member of the American Botanical Council Advisory Board.
A recent BBC investigation found that many of the botanical food supplements sold in the UK contained little or none of the product declared on the label.3 Experts from the University College London analyzed 30 ginkgo food supplement products, and eight were found to contain little or no ginkgo extract. However, all of the HMPs analyzed contained what was stated on the label. “I’m sure this was a shock to most of the public,” Mills said.
HMPs make certain medical claims and therefore require a marketing authorization or registration. Although botanical food supplements must comply with food law legislation, they do not have to be authorized or registered to be sold in the United Kingdom because they do not make medical claims.4 This has led some suppliers to produce low-quality, misleading products, whether out of dishonesty or ineptitude, according to the BBC article.3
Mills advised UK consumers to look for the traditional herbal registration logo that distinguishes a medicine from a botanical food supplement. In some Member States, botanical food supplements are penetrating the market because they are considerably less expensive to produce than HMPs. Mills said that in the face of this competition, the traditional herbal medicine sector is intent on getting the message out that HMPs are more expensive because they deliver results.
“To support this message, it will help to have more consumer-friendly information about licensed or registered herbal medicines,” Mills said.
- Public-friendly information on herbal medicines now available [press release]. London, UK: European Medicines Agency; August 3, 2015. Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002385.jsp&mid=WC0b01ac058004d5c1. Accessed August 4, 2015.
- Ginkgo leaf. European Medicines Agency website. Available at: www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Summary_of_assessment_report_for_the_public/2015/07/WC500191217.pdf. Accessed August 19, 2015.
- Herbal food supplement labels ‘can be misleading.’ BBC website. July 14, 2015. Available at: www.bbc.com/news/health-33504210.
- Food supplements. United Kingdom Department of Health website. September 2011. Available at: www.gov.uk/government/publications/food-supplements-guidance-and-faqs. Accessed August 19, 2015.