Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: a scoping review
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.071 | 0.168 |
| Meta-epidemiology (narrow) | 0.001 | 0.002 |
| Meta-epidemiology (broad) | 0.005 | 0.005 |
| Bibliometrics | 0.023 | 0.022 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.009 | 0.009 |
| Open science | 0.003 | 0.005 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".