International Perspectives on Substantiating the Efficacy of Herbal Dietary Supplements and Herbal Medicines Through Evidence on Traditional Use

Abstract

The efficacy of botanicals in medicines can be substantiated with evidence on traditional use, whereas in foodstuffs, this is often not possible. In Europe, for example, the evaluation and subsequent authorization of health claims on herbal dietary supplements (HDS) have been put on hold by the European Commission. This study aims to analyze the role of evidence on traditional use in international legal frameworks of foods and pharmaceuticals. Both legal sources as well as scientific studies offering insights into these regulatory frameworks were included into the analysis. The international approach toward evidence on traditional use for substantiating efficacy of botanicals varies highly. For herbal medicines, substantiating efficacy with evidence on traditional use is possible in all studied jurisdictions, except for Japan and the United States. HDS efficacy can only be substantiated with evidence on traditional use in India and New Zealand, although the enforcing authorities do not describe which data are required. Australia and Canada regulate botanicals in a separate “borderline” category from foods and pharmaceuticals. Both jurisdictions allow for substantiating efficacy with evidence on traditional use. This study's second objective was to assess the applicability of the international approaches in the European legal framework, in light of the ongoing political debate regarding the use of traditional evidence. Implementation of the analyzed international approaches would require major revisions of the current European legal framework. This review of international approaches might, however, aid in deciding upon future approaches for substantiating health claims with evidence on traditional use.

Fifteen Years of Regulating Nutrition and Health Claims in Europe: The Past, the Present and the Future

“…The Commission and the Parliament have not yet decided upon whether these claims need to be reviewed similarly to other food related claims, or whether different substantiation requirements should be defined. Suggestions are made to allow data on 'traditional use' to support such claims, which is also allowed for substantiating safety and claims of traditional herbal medicinal products [17,61].…”

“…With the entry into force of the NHCR in 2006 and the call to submit dossiers for claims on food products that were based on generally accepted scientific evidence by 2008, many claims were submitted that dealt with health effects of botanicals [46,60]. A number of these dossiers refers to the traditional use of these products for their putative health benefits, a type of information that is also used for traditional herbal medicinal products [61]. Under the current legislative procedure for claims, such data are not considered to sufficiently substantiate health claims.…”

(Poly)phenol toxicity in vivo following oral administration: A targeted narrative review of (poly)phenols from green tea, grape, and anthocyanin‐rich extracts

“…Other countries have varying regulations for foods, drugs, and dietary supplements, but (poly)phenol‐rich botanical and herbal supplements and functional foods are rarely considered as a separate category. Because of this, we will not review them here, though the reader is directed to recent reviews discussing the regulatory framework of foods, drugs, and dietary supplements in other countries (Diaz et al, 2020; Lenssen et al, 2019).…”

Evidencia de citrato de sildenafilo en formulaciones herbolarias afrodisíacas comercializadas en San Salvador, El Salvador, por metodología HPLC-DAD y RMN 1H

“…1 Existe una gran variedad de estos productos en el mercado que prometen un tratamiento eficaz y seguro para distintos padecimientos de salud, sin tener evidencia científica al respecto. 2,3 Se está reconociendo cada vez más, que la disfunción eréctil en hombres es un problema de salud común. 4 Se estima que a la edad de 40 años, aproximadamente el 40% de hombres posee algún grado de trastorno eréctil.…”