“By May 1 2014 all unlicensed herbal medicines – those without a THR or Product Licence – must be removed from your shelves,” Penny Viner, chair of the UK Herbal Forum, told retailers yesterday.
But that was one of the few things about the future of the herbals category that could be described as clear-cut, said Viner – who was speaking at this year’s Health Food Institute Lunch.
For example, the ruling does not apply to “correctly presented botanical food supplements” – although Viner said brands should expect questions from the authorities about whether individual products are correctly presented as botanical food supplements
The future for botanicals, and its potential as a counteractant to the licensing regime (providing a safe home for herbs not inescapably ‘medicinal’) is particularly unclear, said Viner.
There is currently no legal definition for ‘botanicals’ – although the European Food Safety Authority (EFSA) has one of its own, which is remarkably similar to its definition for herbal medicine.
Botanical food supplements are sold under food law – they are generally accepted to optimize or maintain health (herbal medicines have properties preventing or treating disease, or correcting physiological functions). But both food supplements and herbal medicines can effect physiological function – and use similar ingredients and forms of presentation.
The migration of products with herbal ingredients to food supplements has created what Viner called “confusion of non-THRs at greater potency than THRs”.
“The migration of products with herbal ingredients to food supplements has created what Viner called ‘confusion of non-THRs at greater potency than THRs’”
But there is also confusion around basic interpretations of what is, and what isn’t a herbal medicine – so, a product may be designated a herbal medicine in one EU member state and classified a food supplement in another. Similarly, a member state many not classify a product as a medicinal because it contains medicinal herbs.
One of the key criteria for assessing whether a product is medicinal – and assessments are made on a product-by-product basis – is the dosage level. Another important demarcation point is ‘does the product exert a pharmacological effect?’.
A further layer of uncertainty concerns the ability to make claims for botanicals. Viner pointed out that over 1500 claims for botanicals (submitted under the terms of the Nutrition and Health Claims Regulation) remain ‘on hold’. Claims for botanicals were parked , she said, when it rapidly became clear that very few would gain EFSA approval.
Viner said that the so-called BELFRIT list – a comprehensive of list of botanical ingredients appropriate for use in food and supplements – could offer a ray of hope. The project, set up by Belgium, France and Italy (hence BELFRIT), looks as if it may attract the participation of other member states.
Viner commented: “This is a big initiative and overall a good thing. If it gathers momentum and others countries sign up – and the list gets bigger – it may prove then harder for EFSA to dispute whether or not particular substances are appropriate as ingredients for food supplements.”