BACKGROUND

Botanical ingredients based on plants, algae, fungi or lichens have become widely available on the European Union market offering numerous preparations with considerable differences in classification. They are under the categories of food supplements, herbal medicinal products, cosmetics or medical devices.

PURPOSE

The aim of the present work is to highlight how the European regulations concerning the different categories of botanicals can lead to different commercial choices such as time/cost for product development, application for a marketing authorisation, permitted indication (medical or health claim), and as a consequence, the same botanical products are sold in European Union as herbal medicinal products, food supplements, cosmetics or medical devices. Five different widely used botanicals, namely St. John's wort, valerian, ginkgo, ginseng, and green tea were selected to better explain the failure of harmonization through European Union.

METHODS

A search of PubMed, ScienceDirect, European Medicines Agency and European commission web sites for medical devices and cosmetics, and European Food Safety Authority websites were conducted and the available information on regulation of herbal medicinal products, food supplements, medical devices and cosmetics in the European Union was collected. In addition, a market survey of all the sold botanical products in Europe was analysed by consultation of the medicines, medical devices, cosmetic and food agencies websites of the European countries.

RESULTS

The current European legislation needs implementation and follow up because in the different countries the legal positions of the botanical products varied and it is possible to find the same product classified in the different categories, namely registered medicinal product including prescription only medicine, traditional herbal medicinal product, well established herbal medicinal products or food supplement, or medical device, or homoeopathic/anthroposophical medical product, cosmetic.

CONCLUSIONS

There is an urgent need of harmonization, together with the implementation of interoperable vigilance databases, to avoid borderline options.