New research raises quality issues of herbal supplements

(10 August 2022) A new, peer reviewed study published in Frontiers in Pharmacology(1), suggests that consumers should be cautious when buying unregulated supplements containing herbs, as some have been found to be prone to quality issues.

Herbal products containing the same ingredient and regulated under different categories can be of different quality. In this study, the quality of herbal medicines granted a Traditional Herbal Registration (THR) were compared with products categorised as food supplements in the UK. Both categories of herbal products contained the three most popular herbs, milk thistle, echinacea (coneflower) and black cohosh. The products were analysed using High-Performance Thin Layer Chromatography (HPTLC) fingerprints which can detect adulteration and other quality issues in herbal products.

Whilst 100 per cent of the THR herbal medicines contained exactly the herb and concentration displayed on their label, this was not the case with the food supplements where quality issues were found in 52 per cent of milk thistle products, 25 per cent of echinacea products, and 46 per cent of the black cohosh products.
Amongst the food supplement products tested, the research found quality issues that included: the absence of the herb declared on the label of the product, a lower concentration of the herb in the product than specified on the label, and the presence of undeclared herbs, incorrect species of herb and/or other adulterants.

UK pharmacies, health stores and supermarkets commonly stock herbal medicine products and food supplements but few consumers realise that there are two types. The first are regulated and assessed for quality and safety by the UK’s Medicines and Regulatory Healthcare Products Regulatory Agency (MHRA) and once approved for sale, display the Traditional Herbal Medicine (THR) symbol on the packaging. The second are unregulated food supplements that contain herbs and are sometimes combined with vitamins and minerals. These food supplements will comply with Good Manufacturing Process (GMP) if they are produced by companies that are member of a UK Trade Association (see below). However, for products that are produced by companies who are not members of specific trade associations, these food supplements may not be produced to GMP standards and may not contain what is specified on the label, as this latest research shows.

Dr Chris Etheridge, Chair of the British Herbal Medicine Association, medical herbalist and co-author of the research says: “The results show that THR herbal medicines regulated by the government’s MHRA provide a reliable, herbal medicinal product for the consumer to buy. However, whilst there are many responsible manufacturers of unregulated food supplements containing herbs, this is not the case across the board.”

Under the current regulatory system, when buying a herbal medicine for a specific self-limiting condition, such as for joint pain, menopausal symptoms or for cough and cold symptoms, Dr Etheridge advises that “consumers should always look for the THR symbol which is displayed on each pack. This symbol provides assurance that the product is of high quality, regulated by the MHRA and contains exactly what it should. These herbal medicinal products have been assessed for safety and quality and carry an approved medicinal claim on their pack explaining precisely what symptoms they relieve such as hot flushes or joint pain. Inside each pack there is always a Patient Information Leaflet (PiL) that provides important information about its use, and any warnings or contraindications with other medicines.”

Some of the herbs that can be bought in the UK as approved THRs include:

Agnus Castus
Arnica Flowers
Artichoke
Black Cohosh
Blue Flag
Burdock Root
Celery Seed
Clivers Herb
Comfrey Root (external use only)
Dandelion
Devil’s Claw
Echinacea
Eucalyptus Essential Oil
Elderflower
Feverfew
Ginkgo Biloba
Hops
Horse Chestnut
Ivy Herb
Lavender
Lemon Balm
Liquorice
Milk Thistle
Nettle Leaf
Norway Spruce
Passion Flower
Pelargonium
Poplar Bark
Prickly Ash, Southern Bark
Rhodiola
Sage
Senna
Sigesbeckia
St John’s Wort
Tea Tree Essential Oil
Thyme
Uva-Ursi
Valerian
Wild Lettuce
Witch Hazel
Yarrow Herb

Consumers can find brands that provide approved, regulated THR herbal medicines from the British Herbal Medicine Association / www.bhma.info

However, some herbs are not yet available as THR herbal medicines. Consumers who wish to buy these herbs for their health will only be able to find them in the food supplement category which should be bought from credible brands registered with one of the following UK Trade Associations:

• The Health Food Manufacturers Association / www.hfma.org.uk
• The Proprietary Association of Great Britain / www.pagb.co.uk
• The Council for Responsible Nutrition / www.crnuk.org

Ends

Refs:
(1)Frommenwiler DA, Reich E, Sharaf MHM, Cañigueral S and Etheridge CJ (2022) Investigation of market herbal products regulated under different categories: How can HPTLC help to detect quality problems? Front. Pharmacol. 13:925298. doi: 10.3389/fphar.2022.925298

Notes to editors:

Two organisations continue to work to ensure proper regulation and the provision of safe, high quality herbal supplements to consumers in the UK:

1. The British Herbal Medicine Association (BHMA) has represented the interests of herbal medicine in the United Kingdom for almost 60 years. Founded in 1964 at a time of increasing regulatory control and when herbal medicine in this country faced an uncertain future, the BHMA played an important role in convincing the government of the day to include provisions for the herbal industry and profession in the Medicines Act 1968. Members of the Association include manufacturers of herbal medicines, herbal practitioners, companies involved in the supply of herbal raw materials and extracts, academics, pharmacists, retailers and students of phytotherapy. The Board endeavours to support the members, keeps a close watch on legislative developments affecting herbal medicine, liaises with regulatory authorities, industry forums and the media, providing advice and comment on new EU or UK legislation and guidelines, and commenting on other specific herbal medicine issues. The BHMA has recently established the Herbal Practitioners Suppliers section to bring together many of the UK practitioner herbal suppliers from the Western, Chinese and Ayurvedic herbal medicine traditions for the first time. Ten members are currently members and have been awarded the quality standard, HerbMark®, which is only awarded to companies that are members of the scheme, following the successful completion of an in-depth audit process to help ensure that herbs administered by UK practitioners (phytotherapists, herbalists and medical herbalists) are manufactured to pharmaceutical standards, ensuring consistently high quality and effectiveness for their patients. For more information visit www.bhma.info

2. The Health Food Manufacturers Association (HFMA) operates three long-standing codes of practice – for GMP, Labelling & Advertising and Upper Safe Levels for Supplements – to ensure that member companies adhere to high standards and offer good quality, safe products to UK consumers. As such, we welcome proportionate and clear legislation designed to ensure that consumer choice is informed by responsible and accurate information. The HFMA’s Code of Advertising Practice was formed in 1978, and the first label and advertising advisory service in 1998. The Code sets out the regulatory framework for specialist health products, and is administered by the HFMA’s Primary Authority-accredited CLEAR CHECK™ service. For more information visit www.hfma.co.uk

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