The MHRA has been attacked by herbal medicine manufacturers like Schwabe, along with some botanical academics, for failing to strip herbal products not holding registrations under the EU Traditional Herbal Medicinal Product Directive (THMPD) from retail shelves.
But the agency told NutraIngredients its enforcement actions had not been influenced by any European Court of Justice (ECJ) ruling since just after the time of the THMPD’s writing into law in 2004.
“In terms of the ECJ rulings the MHRA amended its classification processes and guidance to reflect their effects in 2005,” an MHRA spokesperson said.
Wider issues
The agency said it wrote to 272 companies prior to the full implementation of the THMPD in April this year, with 132 responding that they had some 2915 products with medicinal product registration exemptions under pre-THMPD UK laws.
“The MHRA is aware of some companies labelling products as food supplements which might be medicinal products and is investigating those companies,” the spokesperson said
“The MHRA is considering the wider issues arising and how effective, proportionate enforcement action can best ensure that the intended benefits of the legislation for consumers and for companies compliant with the legislation are achieved.”
“The Medicines Borderline Section of the MHRA is currently investigating nine companies complained about by the manufacturers of registered herbal medicines. The time taken to process a complaint will depend on the complexity of the case, the number of products involved and the response from the company concerned. Five other complaints have been investigated by the Section and closed.”
The agency said that in the years 2009-10 and 2010-11, its Medicines Borderline Section processed 986 complaints and concluded, “667 cases involved products which could be classified as medicines either by virtue of their presentation, by virtue of their function or both.”
In such cases it seeks voluntary compliance, “but six provisional determinations were issued in that two year period and eight final determinations.”
“One company received formal cautions in October 2011 for manufacturing and distributing by way of wholesale dealing herbal medicines which did not have the appropriate authorisations.”
Borderline
There had been no post-2005 enforcement policy revision, she said, despite accusations ECJ rulings like Hecht-Pharma v Staatliches Gewerbeaufsichtsamt Lüneburg (January 15, 2009) regarding red rice marketing blurred the supplement-medicine borderline.
Those accusations have come from the likes Schwabe and the British Herbal Medicines Association (BHMA)-backed Safer Herbal Medicines Campaign it has founded to highlight the issue of lax policing of what it regards as inappropriately marketed and potentially unsafe products.
A flurry of letters has also been written by herbal academics expressing concerns about the way policing is being affected in the UK due to the influence of ECJ rulings.
In one of those letters written by Reading University’s Elizabeth Williamson,PhD, she noted of the same ECJ red rice decision, that, “a product cannot be regarded as medicinal where it is ‘incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.”
Mockery?
UK herbal products veteran, Dr John Wilkinson, director and regulatory consultant at Herbal Sciences International UK, added the THMPD situation was nut unique in terms of shifting the grounds of legality for products.
“I have been walking into health food shops and pharmacies for past 25 years and this has always been the case,” he said.
“Now with the internet, there are thousands of illegal products that are available to UK consumers. This makes a mockery of EU legislation such as the novel foods regulation, the THMPD and also basic food law requirements.”
Groups like the Alliance for Natural Health (ANH) have been heavily critical of the THMPD and the SHMC which it states discriminate against herbal traditions like Chinese and Ayurvedic medicines, none of which have yet won a THMPD registration, along with some herbal food supplements like valerian.