April 2010 – An Opportunity for the Herbal Industry Jonathan Griffith

WHAT IS GOING ON? 1984 DoH announces that anyone supplying herbal medicines to the Irish Market should submit them for licensing. 1984/ Some companies attempt to work the process 1992 Some full medical licenses granted before being shelved in favour of EU THMP initiative Irish implement Food Supplement Direcitve. Notification of new Products required April 2010 THMPD registration deadline ; Notification deadline for all botanical supplements

IHTA Approach Heretofore, the authorities have approached classification of Herbal products from a medicinal perspective: Little scope for meaningful diagloue Tendancy to classify most botanical supplements as medicines The IHTA is trying to gain an acceptance for a more balanced Approach using both Food and Medicine Legislation. Creating the possibility for on-going meaningful dialogue Allowing for the possibility of retaining a viable botanicals market Establishing clarity and a uniform trading platform

The Criteria 1. If you make a medical claim, your product is a medicine. 2. If there is an EU Pharmaceutical Monograph for an ingredient in a product, the product is likely to be classed a medicine. 3. If the applicant can establish that all ingredients in the product have a recognised food use, the product may be sold as a food supplement.

Dual Possibility Where a product contains an ingredient that is both the subject Of an EU monograph and has a recgnised food use, resolution Will be sought by reference to: 1.Overall labelling and presentation 2.To what extent is the ingredient essentially similar to the recognised food or medicinal form 3. Are there any safety concerns with the ingredients?

Lists of Botanicals There are a number of lists floating around these days: e.g. HFMA list, Botanic Forum List, EHPM Health Claims list IHTA is trying to establish authoritative lists of: Plants that have a recognised food use Plants that are likely to be considered medicinal Forms that are okay for foods and forms that are not.

Threat or Opportunity? There is a threat that many products that are currently on the Market may be withdrawn: Because they do not comply with the regulations; Because food supplement suppliers choose not to upgrade to Pharmaceutical standards; Because of insufficient sales volumes There is also enormous opportunity: For the first time in 30 years we know what the rules are and we can see the way forward for our products; For the first time in 30 years it makes sense to invest in the market; … provided the authorities do apply the regulations unilaterally