Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: a scoping review

Abstract

Background Over the last decade, the use of dietary and herbal supplements (DHSs) has expanded greatly across national healthcare settings for the prevention, management and/or treatment of a variety of health issues. Although regulatory policies for DHSs across different countries have been aimed towards evaluating safety and efficacy, performing quality controls, monitoring the manufacturing practices, and encouraging further research, significant safety issues have emerged from inappropriate regulatory classification, lack of suitable quality controls, and inadequate testing and labeling of these products. Therefore, the purpose of this scoping review was to identify facilitators and barriers to DHS regulation across different countries. Methods A scoping review was conducted and informed by the five-stage methodological framework proposed by Arksey and O’Malley and further enhanced by Levac et al. MEDLINE, EMBASE, AMED, and PsycINFO databases were systematically searched for eligible articles from database inception to September 29, 2020. Studies analyzing DHS regulatory frameworks were eligible for review. Relevant data from eligible articles were extracted and categorized into themes to provide a descriptive overview of the literature. Results Searches generated 4314 results, 1800 of which were duplicates, followed by 2472 that were excluded after screening the titles and abstracts of these articles. Of the remaining 42 full-texts, 15 eligible articles were included in this review. Themes identified include: (1) increased financial and human resources encouraging knowledge expansion as a facilitator to DHS regulation; (2) variances in DHS classification and regulatory requirements across countries as a barrier to DHS regulation, and (3) collaboration between various stakeholders (experts, policymakers, representatives of regulatory bodies, product companies and research institutions) facilitating DHS regulation. Conclusion The present scoping review identified facilitators and barriers to DHS regulation across different countries. We highlight that safety assessments of DHSs continue to be inadequate, and emerging technologies could potentially play a significant role in establishing common reference standards of herbal materials and products between regulatory agencies. Regulatory harmonization, increased scientific research, and collaboration could improve regulations globally through appropriate categorization and safe application of DHSs.

Medicinal Values and Potential Risks Evaluation of Ginkgo biloba Leaf Extract (GBE) Drinks Made from the Leaves in Autumn as Dietary Supplements

“…As an alternative to traditional medical therapies, dietary supplements (DS) are widely used worldwide [ 4 , 34 ]. Tea and functional wines, as daily health drinks in China, have been traditionally used as medications based on personal experience for thousands of years [ 8 ].…”

“…Owing to the unique pharmaceutical functions of GBE in the treatment of many degenerative diseases (e.g., Alzheimer’s disease), GBEs are one of the currently best-selling commercialized herbal products [ 1 , 2 , 3 ]. Dietary supplements (DS) are usually used for healthcare in traditional medical therapies [ 4 ]. Elders in China are always concerned with the medicinal values and potential risks of homemade ginkgo leaf products (ginkgo tea and ginkgo wine) as GBE DSs when staring at the ginkgo trees surrounding them [ 5 , 6 ].…”