Irish regulator “out of order” on herbal supplements – ANH

A draft Guide from Ireland’s medicine regulator telling retailers which herbal products they should or shouldn’t sell would effectively ban food supplements containing many of the health trade’s best-selling herbs.

That’s the warning from campaign group the Alliance for Natural Health, which accuses Ireland’s Health Products Regulatory Agency (HPRA) of creating a “herbal divide” by developing policies at odds with other national regulators in the EU.

This week, the HPRA ended its consultation on The Guide for Retail Sale of Herbal Medicinal Products, which it says is intended to “assist retailers in determining which herbal products may be medicinal and, as such, require prior authorization or registration with the HPRA before being sold”.

But the Alliance for Natural Health says that “hidden inside the draft guide is something much more sinister – a de facto plan to ban outright all food supplements selling in Ireland that contain the herbs Echinacea, black cohosh, St John’s wort, butterbur, Devil’s claw, globe artichoke leaf, goldenseal, greater periwinkle, lesser periwinkle, Griffonia and ginkgo biloba.”

Commenting further, ANH says: “We say that guidance that tells retailers they cannot sell these herbs as food supplements is utterly inconsistent with European Union case law. That’s because the proposed guide restricts the sale of these herbs as food supplements at any dose, in any formulation, regardless of amount. European case law has made very clear that it’s the dose that matters. This means that medicinal determinations by a member state regulator like the HPRA should be made on a case by case basis, taking into account things like the amount of active ingredient(s), claims, posology, etc.”

The Irish Association of Health Stores (IAHS) says the lists produced by the HPRA as part of the proposed Guidance would be unworkable for the average retailer. “The feedback we have had from our members in relation to this Guide is that the level of complexity attached to it makes its application in the workplace almost impossible”, said IAHS president Jill Bell.  She added: “One would have hoped that a simpler and more workable Guide which would have aided retailer compliance would not have been beyond the HPRA’s capabilities.”

ANH’s scientific and executive director, Rob Verkerk, added: “The HPRA’s approach, as a national medicines regulator in the EU, is out of order. This is especially the case given the medicines regulator has no legal competence over foods or food supplements.

“In addition, any member state regulator should abide by European case law and take note of other initiatives that are trying to provide a rational, yet liberal, single market for botanical food supplements EU-wide, that allows consumers freedom of choice. Relevant other initiatives include the EU-funded PlantLIBRA project and the BELFRIT list that brings together the views of the Belgian, French and Italian regulators in this area.

“Momentum behind BELFRIT is increasing, with Romania and Netherlands coming on board – and it seems that the Irish, as well as the UK, Germany and the Nordic countries are increasingly out of step.  A herbal divide is in the making and it is just a matter of time before the European Court will need to be brought in to intervene.”