Why do we have for health claims different criteria between plant based food supplements and herbal medicinal products?

Abstract

It seems obvious for most of the people that there are strong differences between botanical food supplements and herbal medicinal products, especially because consumers as well as treatment goals are not the same. However, some main convergences can be observed as for example quality and safety. A key question today is why for a given plant and the same preparation, the requirements imposed by the official European authorities (EMEA) are less severe in terms of clinical assessments to get a marketing authorization for a food product in comparison to a medicinal product? In the EU, traditional herbal medicinal products having a long history of prior human usage can be registered under a special, simplified registration procedure without the necessity of providing some proofs of efficacy with clinical trials. This is the consequence of a specific legal framework known as Directive 2004/24/EC. On the contrary, regarding food products, EFSA requires randomized clinical trials on healthy subjects and under such requirements no “traditional claims” will obtain a positive opinion from this Authority. Furthermore, it is really difficult to understand that for a drug, designed for a targeted disease and focused on a given pharmacological activity, the proof of its efficacy is not required in a contrary to a food supplement, used to maintain the homeostasis status and to help in minor troubles, where the efficacy proof is required. The dosage of a plant extract being lower for a food supplement than for a drug reinforces the difficulty to get the validation. How can we demonstrate such efficacy on a person without evident pathology but having only some well-being problems? In a scientific perspective, this clinical approach is adapted to pure active substances as vitamins but not to the complexity of plant extracts. Many years ago, a group of experts at the Council of Europe proposed some recommendations to differentiate the requirements necessary for food supplements and for herbal drug medicine, taking into consideration for example the individual impact and the final aim of the product. Unfortunately, this proposal has not been retained. In conclusion, we consider today that the requirements necessary to get a validated health claim for botanical food supplements and botanical preparations are not appropriate, leading to an insoluble situation. European harmonization is more and more necessary.