The UK medicines agency says it continues to monitor the borderline between herbal products classified as medicines as opposed to food supplements on a case-by-case basis, although some categories are now under the complete jurisdiction of new EU herbal laws.
Speaking with us today, the Medicines and Healthcare products Regulatory Agency (MHRA) said ingredients, dosage, physiological effect and marketing continued as the prime factors in determining whether or not a product required a Traditional Herbal Medicinal Products Directive (THMPD) registration or not.
“Our borderline team is assessing the market on an ongoing basis,” an MHRA spokesperson told us. "This is done on a case-by-case basis."
In this direction, a summer agreement had been won with industry that post-menopausal herb, black cohosh, would be deemed a medicinal THMPD herb only and lose its right to exist on the market as a food supplement.
However black cohosh food supplements already on-market were allowed to sell through, a situation that saw the MHRA today call out a black cohosh product made by reputed €3m UK manufacturer, Viridian, over an adulteration issue.
A recall on the ‘Black Cohosh Root’ product was in-process and Viridian owner Cheryl Thallon told us the problem was down to an errant supplier the company had ceased working with.
The company had fully complied with the MHRA demand, Thallon said, after the agency’s testing found it contained another genus of the black cohosh plant (Cimicifuga racemosa), “most probably Cimicifuga foetida.”
It is a problem that has been cited in around 30% of black cohosh products.
Thallon, whose firm has been an opponent of the demand to register all herbal products under the THMPD, said it was the first time the company had been involved in a recall and that its QC measures were sound.
She noted that after the summer meetings with the MHRA, the firm had previously discontinued the black cohosh range.
“Bad batches happen”
Dr Robert Verkerk, the chief and scientific executive officer at the Alliance for Natural Health (ANH) observed of the situation: “Quality control for food supplements is bound by food law, so just as a baker is obliged to sell a safe loaf of bread, a food supplement supplier must also sell safe food supplements.”
“With any food, there can be points in the supply chain where things go wrong and bad batches can very occasionally still work their way through supply chain despite all the checks and balances, including HACCP procedures that are put in place. “
“Viridian Nutrition is in the business of supplying high quality food supplements and the company has no doubt had to take the necessary action to ensure the quality of raw materials used in its products.”
“The MHRA always recommends that registered herbal products are used.”
Although it holds to a case-by-case position, the MHRA backed the THMPD as the best road to market for herbal products in its public warning to Virdian.
“The MHRA always recommends that registered herbal products are used,” it said.
“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.”
The other species
The British Herbal Medicine Association (BHMA) previously said of the black cohosh problem: “Adulteration with the wrong species is rife, with a number of published academic papers citing a rate of around 30% in purchased samples. The adulterants are usually related species, often from China - black cohosh only grows in North America – and usually with uncertain safety profiles.”
“Only the quality assurance of medicine production and the regulatory enforcement of these standards can prevent this adulteration.”