Herbal clampdown: UK seeks to end moratorium by year’s end
It has proposed ending a ‘sell through’ grace that is allowing herbal supplements without EU Traditional Herbal Medicinal Products Directive (THMPD) registrations to remain on-shelf if they were being sold before the THMPD kicked into life in May, 2011.
Now it wants products like St John's wort and ginseng not in possession of THMPD registrations off the shelves by December 31 this year, bringing forward the previous deadline of May, 2014, by several months.
It said the extended ‘sell through’ grace period was compromising the quality assurance goals of the THMPD.
“..achievement of these benefits is held back if there is a prolonged period of sell through of unlicensed products that do not meet any set standards.”
“Even allowing for the recognised challenge for smaller companies, inexperienced in medicines regulation, bringing products into the traditional herbal registration (THR) scheme there has been an extensive period of time for companies to make their preparations where this was their intention,” the MHRA said.
“The MHRA has provided a significant amount of help to companies seeking to bring their products into the THR scheme.”
It has opened a public consultation on the matter that will end on September 6.
The agency said 300 registered products using more than 100 herbs showed the success of the THR scheme among manufacturers selling herbal products in the UK.
“There is likely adverse regulatory impact…”
It said the sell through period was being exploited and posing health risks.
“Although sell through has proceeded well in much of the herbal sector we are concerned at what seems to be a degree of abuse in other parts of the sector with examples of unlicensed herbal products claiming what appear to be implausibly long shelf lives – far longer than are typically agreed for regulated products.”
It added: “For example, the Agency has evidence of products containing species differing from the label and non-compliance with voluntary warning labelling agreed with the trade associations.”
“There is likely adverse regulatory impact on responsible companies who have invested in meeting the standards of the THR scheme.”
It said bringing the deadline forward would have, “no significant effect on the sector and will not impose any additional costs or have any effect on issues of equality.”
Robert Verkerk, PhD, executive and scientific director of the Alliance for Natural Health (ANH) and THMPD critic, said the MHRA move was not unexpected and reflected an EU-wide trend of literal readings of the food-medicine borderline and its manifestation in EU botanical law.
“The full implementation of the THMPD appears to have altered the perception of which botanical food supplements are now classified as medicines, using the very broad definition and scope in EU law,” Dr Verkerk said.
“Some of this new-found zest appears to be because these products, often sold safely for many years, are seen to interfere with the sale of registered herbal medicines.”
The UK Health Food Manufacturers' Association (HFMA) executive director Graham Keen said the proposal was not surprising and that it would, "consult with our members and take soundings before responding to the MHRA’s consultation.”
Consumers for Health Choice (CHC) in the UK also opposed the MHRA proposal. The group said: “We will, of course, produce a draft response to this consultation, highlighting CHC’s opposition to the proposal and arguing that this provision should not be implemented prior to statutory regulation of herbalists being put in place.”
The issue was also raised in a debate in the UK parliament yesterday where the mooted establishment of a register of herbal practitioners was something Conservative MP David Tredinnick said would, “see a large number of small businesses folding, because the whole supply chain of herbal medicine will collapse.”
But Labour MP Kate Hoey urged that the register, “be introduced as quickly as possible.”