Transcript April 2010 – An Opportunity for the Herbal Industry

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.
2003 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Market may be withdrawn: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