|Date:||23 November 2012|
|Subject:||People asked to return Black Cohosh Root capsules made by Viridian Nutrition|
|Contact:||Press Office 020 3080 7651
Out-of-hours 07770 446 189
People who use herbal products are being asked to check if they have any ‘Black Cohosh Root’ capsules that are made by Viridian Nutrition in their homes. If they do, people should return the product to where they bought it because the product has been found to contain an unintended and undeclared plant material.
The Medicines and Healthcare products Regulatory Agency (MHRA) has taken action to request that the manufacturer Viridian Nutrition also recalls their ‘Black Cohosh Root’ capsules from sale in health shops. The manufacturer stopped marketing this product in July but some stock of the product may still be being sold.
Testing found that the product, which should only contain Black Cohosh (Cimicifuga racemosa), also contained another species, most probably Cimicifuga foetida. The undeclared plant material, Cimicifuga foetida, is not generally used in Western herbal medicine and its properties or safety has not been evaluated. This means that the product is not what is says it is or of the quality required and must be removed from the market.
David Carter, Manager of the MHRA’s Medicines Borderline Section said: “We expect a product to list all the correct ingredients on the label. In this instance they were not fully listed and, therefore, the product does not meet the standards required for public use. That is why we have told the company to recall the product from retailers and also to ensure that the recall is communicated to members of the public.”
The MHRA always recommends that registered herbal products are used. Registered products can be identified by the Traditional Herbal Registration (THR) registration number or logo on their packaging. These products have been assessed and quality checked to ensure that they are acceptably safe to use and are accompanied by a leaflet with information on how to use the product with possible side effects listed.
Herbal remedies should be used with the same caution and care as any other medicine as their use will have an effect on the body. While many herbal remedies are reasonably safe, it is important to remember that just because it contains natural ingredients and extracts this doesn’t guarantee it is safe. People should always consult with a pharmacist or doctor to make sure that an herbal remedy is suitable for them to take and will not interact with any other medicines they may be taking.
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Notes to Editor
- The recalled product, which is unlicensed, is labelled as containing Black Cohosh, which is the common name used to describe the herbal ingredient Cimicifuga racemosa, as specified in the European, British and American Pharmacopoeia. However tests carried out on the product have shown that the product also contains other Cimicifuga species. The Agency therefore considers that the inclusion of this undeclared plant means that the product is not of the nature or quality required by the purchaser.
- The MHRA is currently investigating a number of complaints about herbal products being marketed without the necessary authorisation and will continue to take regulatory action to protect the public. In the meantime, should anyone have taken these products or have any concerns they should seek the advice of their GP. Please report any suspected adverse reactions through the Yellow Card Scheme.
- The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk