Herbal medicinal products vs. botanicals: Clear borders are necessary

The borders between herbal medicinal products (HMPs) and dietary supplements of herbal origin (botanicals) have recently been subject of political discussions within the EU. In this context the question arised, whether health claims based on traditional use should become possible for botanicals in the future.

While herbal medicinal products have pharmacological effects and are used for therapy, relief, prevention or diagnosis of diseases, botanicals have a physiological effect and are primarily used for nutrition or health-related effects by healthy consumers.

A transfer of the „traditional use“ principle from herbal medicinal products to dietary supplements, as currently under discussion, is not possible due to the fact that dietary supplements are not designated for the treatment of diseases.

In addition, for herbal medicinal products there is typically a long, well documented tradition of their medicinal use for a well defined indication, as well as of their composition, posology and formulation. In contrast, for botanicals this information is usually lacking, as is the case also in other food items, which are often subject to frequent changes in manufacturing, composition, quality, and nutritional use.

Therefore the GPT (Society for Phytotherapy, Germany) has submitted a statement to the German government reinforcing its position expressed previously and has argued against the introduction of "traditional" health claims for dietary supplements. The German federal government has followed this position when submitting its statement to the EU commission.

Also in the future, the assessment of botanicals should be based on the question whether a relevant health-related effect has been proven by adequate scientific data and whether the dose resp. serving is equivalent to that consumed nutritionally. This is a necessary precondition for providing efficacious and safe products to patients and consumers in the future.