The complexity of proving health effects with data on ‘traditional use’: A critical perspective on supporting botanical health claims

Abstract

BackgroundThere is considerable interest among consumers in using 'natural', plant-based nutritional supplements for their purported health benefits. However, the data required to support health claims on these so-called botanicals is subject to an ongoing debate, especially in Europe. Remarkably, pharmaceutical regulations have a provision that sometimes makes it possible to include data on 'traditional use' in the approval process. Scope and approachIn this critical perspective, we elaborate why substantiation of health benefits with evidence on traditional use is not easy to apply for food products. This is highlighted by the examples of recent incidents with traditional herbal substances such as kava kava and ephedra. These examples demonstrate that safety considerations, which are explicitly considered in the assessment of traditional herbal medicinal products, deserve special attention, and cannot be disregarded in food products that have health claims based on traditional use. Key findings and conclusionsUnexpected safety-related problems may arise when consumers combine botanicals with (prescribed) pharmaceutical products or specific nutrients, as it is often unlikely that such interactions will have been identified during traditional use. Information on both the safety and the health benefits are key to enable consumers to make the best decision for their personal health.As current legislative requirements for food products do not provide the opportunity to include both effectiveness and safety in the assessment, it is questionable whether and how traditional use evidence can be used under the current regulatory framework for health claims on foods.