Poland panel considers borderline supplements

By Shane Starling

- Last updated on GMT

Related tags European union Eu

Poland has established a government-backed group briefed with
developing criteria relating to the classification of a range of
nutrients under either food or medicine law.

The Panel on Dietary Supplements will spend 4-6 months drawing up an electronic database of all on-market supplements and passing opinion on how they should be regulated. The panel seeks a "precise differentiation between dietary supplements and medicines"​ with the objective of improving consumer "safety and to facilitate entry and functioning on the market for manufacturers and distributors",​ according to a post on www.polishmarket.com​. As is the case in many EU member states that are still determining which products should be classified as foods and which as medicines, Poland's panel is likely to classify products under three broad categories: food supplements, medicines and "borderline" products - those that have both food and supplement uses. It is "borderline" products that are the most controversial as dosage and usage issues arise that can make classification problematic. It's the age old question: what is a food and what is a medicine? This dilemma was a fundamental motivation behind the creation of the Traditional Herbal Medicinal Products Directive (THMPD), which seeks to create a category of herbal medicines with its own registration criteria that lies somewhere between food and medicines law. While vitamins and minerals are classified under the Food Supplements Directive (FSD) there are a range of nutrients such as probiotics, animal-derived ingredients such as glucosamine, some essential fatty acids as well as most botanicals that have not been registered under the THMPD, that are open for individual member state classification. While probiotics, glucosamine, fish oils and other specialist nutrients appear to have their foods and supplements use mandated in most member states for the moment, herbals are considered to be in more jeopardy for most in industry would see as the draconian and inappropriate classification of herbs as medicines. Botanical backlash ​Some member states - most recently Belgium - have indicated it will adopt a conservative approach and classify a ranger of "borderline" botanicals such as Echinacea and ginkgo under medicines law. "The problem is that the EU has left it to member states to determine whether a product is classified as a medicine or a food supplement,"​ said Lorène Courrège, director of regulatory affairs at the European Federation of Associations of Health Product Manufacturers (EHPM). "Indeed dietary supplements are regulated by the FSD of 2002 but this does not harmonise the use of ingredients other than nutrients (vitamins & minerals) such as botanicals, fatty acids etc."​ She said EHPM was concerned about momentum within some member states to classify botanicals as medicines and it was difficult to see a harmonised criteria being put in place in the EU soon. A European Commission report was due in April into possible ways to go about classifying botanicals and other nutrients. In Belgium, about 250 herbal products that have been legislated under food law for more than a decade may soon be reclassified as medicines, according to the supplements trade association there.

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