The Medicines and Healthcare Products Regulatory Agency (MHRA) has asked Viridian Nutrition to recall its Black Cohosh Root capsules after products were found to contain quantities of the wrong species of plant.
Testing found that the product contained both Black Cohosh (Cimicifuga racemosa) and other species – Cimicifuga foetida and Cimicifuga racemosa. The MHRA says that since the undeclared plant material is not widely used in Western herbal medicine its properties and safety have not been evaluated. On that basis, the Agency says, 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.
Viridian says it had already delisted its Black Cohosh back in June following discussions with the MHRA about the status of the product as a food supplement. Talking to Natural Products about the contamination problem (the BHMA says adulteration of Black Cohosh is “rife” and probably affects upwards of 30% of products on the market) Viridian managing director and founder, Cheryl Thallon, said: “It has been suggested that the problem may stem from cross contamination from nearby fields containing different species, such as Cimicifuga foetida. So, this absolutely isn’t a case of a company, or companies, deliberately cheapening products. In this case the problem lay with an errant supplier – that Viridian no longer trades with.
“We operate SOPs, we have full paper trails of ingredients and our products are correctly labelled and contain industry-agreed guidance on safe use. There wasn’t a safety issue here and Viridian has no previous history of errant manufacturing. So it does feel to us that it has been handled in a heavy-handed way. We don’t blame the regulator – they are in the invidious position of having to interpret badly conceived and poorly written law. But as a small business owner you are left feeling like a borderline criminal!”