The HMA express grave concerns regarding possible scenarios which are introduced in "Discussion paper on health claims on botanicals used in foods" published by the European Commission (EC). The outcome of this discussion may have a major impact on the future of the traditional herbal medicines regulatory regime, therefore every change of the current system should be evaluated very carefully to avoid any threats to public health safety.
The discussion paper on health claims on botanicals used in foods was published in August 2012 by the EC. The paper highlights the parallel legal regimes for herbal substances (referred to as botanicals) for traditional herbal medicinal products and for food supplements. It is noted that products containing botanicals can, because of the physiological/pharmacological effects on the functions of the body, be considered and marketed either as medicinal products or as foods (food supplements). It is also noted that different approaches exists among EU Member States on how botanicals can be marketed as well as what kind of legal framework should be applied for these products.
As with all medical products, those containing botanicals need a pre-market authorisation and can be manufactured only by operators with a licence to manufacture. Directive 2004/24/EC on traditional herbal medicinal products introduces a simplified traditional use registration that can be granted by national competent authorities upon applications submitted by operators. The application must include full tests on pharmaceutical quality and sufficient safety data. However there is no need for the applications to include references to pre-clinical tests and clinical trials provided that the product proves not to be harmful under the specified conditions of use. Similarly, the pharmacological effects or efficacy are considered as plausible on the basis of traditional use.
While herbal substances presented as food (food supplements), under the terms of Regulation EC 1924/2006, may make claims for nutritional benefit and health benefit provided these claims have been previously evaluated and are supported following scientific evaluation by the European Food Safety Authority. Products marketed as food supplements can only be promoted for claims pertinent to those evaluated by EFSA. While they are required to be of good quality, hygiene compliant and labelled in accordance with food law, they are much less rigorously regulated than comparable traditional herbal medicinal products which must be manufactured in licensed premises under the conditions of Good Manufacturing Practice conditions.
The decision to accept products under one or the other regime remains with the Member States and in some Member States certain herbal substances may be widely used as food supplements provided they do not make medicinal claims whereas in other countries products are classified as a medicinal product. Considering that the different requirements in these two areas of EU law can lead to important differences in the level of information that is provided to consumers on products which are apparently similar, the discussion paper addresses the question as to whether this difference should be maintained or not.
In the discussion paper the EC suggests two scenarios on how to proceed. In the first option, the status quo is maintained and EFSA would resume the assessment of health claims with no changes to its approach. In the second, it is suggested that the peculiarities of the "botanical case" be taken into consideration and EFSA should modify or waive the requirements for proof of the health claims in the same way that clinical efficacy is waived in the case of herbal medicinal products.
The HMA believes that approaches of evaluation by EFSA are scientifically verified and are in line with their current respective legislation. The sound evaluation of health claims by EFSA is a case-by-case approach in line with the legislation and the criteria established by EFSA, therefore ensuring that products put on the market are safe and adequately labelled. Also HMA considers that all health claims should be evaluated in the same way. No special considerations should be made for health claims made on botanicals used in foods, including food supplements.
Regarding to the second suggestion, HMA believes that a special provision should not be made for botanical claims at the EU level by accepting a lower grade of evidence or relying on traditional usage alone. Data supporting the traditional use of herbs in a particular medical context is not sufficient to support a nutritional function for such herbs. If special provisions are made for botanical health claims, there would be no safety assessment in addition to assessment of health claim before they go on the market. In contrast, botanicals registered as traditional herbal medicinal products undergo safety assessments prior to being put on the market. Evidence of traditional use alone is not enough for a product to be classified as traditional herbal medicinal products. Consumers must be protected by a consistent level of scientific scrutiny on safety and quality regardless of whether health claims are made on products containing botanicals or not.
Also HMA are concerned that with the second suggestion botanicals which should be registered as traditional herbal medicinal products may instead be classified as food supplements. If special provisions are made for botanical health claims, there would be no safety assessment in addition to assessment of health claims before they go on the market. In contrast, botanicals registered as traditional herbal medicinal products undergo safety assessments prior to being put on the market. As a result there could be the possibility that marketing authorisation holder of herbal medicinal products would register products as food supplements in order to avoid scrutiny on safety and quality considerations. It would establish the possibility that some products could circumvent the registration procedures for traditional herbal medicinal products introduced by Directive 2004/24/EC.