In Sep 2010 the European Food Safety Authority (EFSA) decided to put on hold the assessment of 1,548 health claims for plants and herbals (botanicals). The challenge is the interrelation between herbal Traditional Herbal Medicinal Products (THMPs) and herbal foods; Regulators are asking how do they separate herbal medicinal activity from food health claims in the EU market? EFSA approval requires scientific evidence of efficacy, whereas the THMPD relies on evidence of traditional market use, and a rigorous safety assessment. To complicate the matter, the approach to botanicals is not harmonised across the EU, a food in one EU country could be considered a medicine in another. This on hold status remains unchanged for the foreseeable. It would be considerable blow to the Industry if no botanicals claims were ever approved. Avena Consultants is frequently asked for the ‘list’ of what is and is not medicine. There is no ‘list’ in the EU; we have years of experience and precedents to draw on and study each formula on a case by case basis, we can tell you if your product is considered a food or a medicine.