The MHRA is consulting with industry over its proposal to put an end to the sell-through of unlicensed herbal medicines.
In April 2011, a transition period under the Traditional Herbal Medicinal Products Directive came to an end, meaning that all herbal medicines had to be licensed under the Traditional Herbal Registration scheme if they were to continue to be sold as such. But before the end of the transition period, the MHRA said it would allow stocks of products that were already legally on the market in retail before April 30, 2011 to be sold through.
However, the MHRA is now proposing that this sell-through period come to an end on December 31, 2013 and is consulting on the plans until September 6.
In its proposal, the MHRA says it will issue revised guidance to the effect that “sell through” of unlicensed herbal medicinal products that were already lawfully on the market at the end of the transition period under the herbals Directive (30 April 2011) will not be allowed to be sold or supplied beyond 31 December 2013”.
In explaining its reasoning, the MHRA said there has been an extensive period of time for companies to comply, and says it is concerned at a “degree of abuse” in other parts of the sector, with products having “implausibly” long shelf lives.
Commenting on the proposals, Graham Keen, Executive Director at the Health Food Manufacturers’ Association, told Health Food Business: “The THMPD has had a long transition process, and this proposal should come as no surprise to those member companies selling through their pre-transition product. As usual, we will consult with our members and take soundings before responding to the MHRA’s consultation.”
Dr Jen Tan, Scientific Director at Bioforce, commented: “We are not sure that ending the sell-through period at the end of December 2013 will bring any greater clarity to the issue of unlicensed herbal remedies. Any product relevant to the market and supplied prior to April 2011 should have sold through by now – otherwise, it would be wasting space on retailers shelves. More importantly, this does not address the question of what is allowed as a botanical food supplement.”
Adam Smith, Science and Communications Officer at the Alliance for Natural Health International (ANH-Intl), added: “It’s not surprising that the MHRA is fixing an end date for the sell-throu gh period, although the expectation in some quarters was for April 30, 2014. An April date would have ensured that herbal products without Traditional Use Registrations (TURs), but sold legally under the old Section 12(2) exemption to the 1968 Medicines Act, had the full three years shown on their shelf lives.
“A bigger concern at the moment is how the MHRA and other EU medicines regulators are interpreting the food/medicine borderline for herbal food supplements or botanicals. Now that we have the THMPD, the regulators increasingly seem to think that it’s the only, or at least the preferred, option for botanicals. More and more products are being classified as medicines as a result. It’s hardly coincidental that these botanical products, sold safely for a long time, are seen to interfere with the sale of expensively registered herbal medicines.”
The launch of the consultation has come at the same time as the matter of statutory regulation of herbalists was discussed by MPs in Westminster, driven by Consumers for Health Choice lobbying, in which the organisation was noted.
CHC says it will be providing a response to the consultation, indicating its opposition and arguing that it should not be implanted prior to the statutory regulation of herbalists being put into place.
* Look out for the August issue of Health Food Business for more detailed comment.