by Dr. Alan Ruth, CEO of the IHTA
Working to protect the specialist health products sector.
The Irish Health Trade Association (IHTA) represents the interests of manufacturers, importers and distributors of specialist health products. These products include vitamin and mineral supplements, herbal medicines, homeopathic medicines, flower remedies, natural body care products and health foods.
The IHTA is a member of the European Health Product Manufacturers’ Association (EHPM) and works closely with the EHPM to protect and nurture the industry’s interests across Europe. It also works closely with the Irish Association of Health Stores (IAHS) and the UK Health Food Manufacturers’ Association (HFMA).
Recent times have presented a number of obstacles to the specialist health products sector. Three of the greatest obstacles are:
EU legislative and regulatory developments
Widespread distorted, negative reporting in the media
A lack of acceptance by the allopathic (conventional) medical community for the use of such products in health care
Three of the legislative obstacles are: the Food Supplements Directive, the Nutrition and Health Claims Regulation, and the Traditional Herbal Medicinal Products Directive.
The Food Supplements Directive (FSD) aims to harmonise laws relating to food supplements for the purpose of facilitating free trade of food supplements within the EU, while also protecting consumer health. In the near future, it will be amended to limit both maximum and minimum daily dosages of vitamins and minerals in food supplement products across the EU.
It is possible that the ‘maximum permitted levels’ of vitamins and minerals will be set so low that they will be less than the levels currently available from popular higher potency supplements. The FSD will eventually also be applied to supplements containing other groups of nutrients. The IHTA and other trade associations are working hard to help ensure the continued availability of safe, beneficial higher potency supplements.
The Nutrition and Health Claims Regulation (NHCR) applies to foods (and food supplements). It aims to harmonise nutrition and health claims made on labels and in advertising throughout the EU. The European Food Safety Authority (EFSA) is currently evaluating claims and when the approved list is published, companies will be required to alter their current claims to those that use an approved claim for a specific generic ingredient.
No product specific claims will be allowed unless they have been approved. The NHCR has the potential to cripple small and medium sized enterprises because product-specific claims applications are excessively onerous and require evidence from randomised clinical trials (RCTs). RCTs are prohibitively costly to carry out and lack relevance for foods or food ingredients with many years of safe use.
The Traditional Herbal Medicinal Products Directive (THMPD) relates to traditional herbal products, substances and preparations. In some EU Member States, there is a high risk that many botanicals that may rightfully be considered as botanicals under the EU food supplement regime may be categorized as ‘herbal medicinal products’.
Under the THMPD, products are subject to pharmaceutical stability testing and significant compliance costs apply. This will place a huge financial burden on small and medium sized enterprises. It will also make the cost of products that have complied, too expensive for some consumers, thereby limiting their right to choose with regard to decisions about their own healthcare.
If you would like more information about the IHTA, please contact Phil Costigan at the IHTA Secretariat: Ph: +353 1 2860377 E-mail: info@ihta.org
