Assessment of herbal medicinal products: challenges, and opportunities to increase the knowledge base for safety assessment
Abstract
Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantity and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.
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The purity of plants may be compromised by dirt, weeds, bacteria, moulds, and multiple contaminants such as pesticides, toxic metals, and polychlorinated biphenyls.
“The purity of the plants may be compromised due to several factors, namely, by the presence of dirt, weeds, bacteria, moulds, and multiple contaminants (e.g., pesticides, toxic metals, polychlorinated biphenyls (PCB), etc) (Jordan et al., 2010;Luo et al., 2021).”
From Multi-target neuroprotective effects of herbal medicines for Alzheimer's disease (2022) · cites this paper as Jordan et al., 2010
The quality of herbal medicine products is a particular challenge in safety data.
“A particular challenge in safety data on herbal medicines is the quality of the products.”
From Multi-target neuroprotective effects of herbal medicines for Alzheimer's disease (2022) · cites this paper as Jordan et al., 2010
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Ichim, M. C. (2019) · Frontiers in Pharmacology · doi:10.3389/fphar.2019.01227 · Cited by 148 · see citing works
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“monnieri products are classified as herbal or natural products, and in most countries, the regulatory requirements to market natural products are less stringent compared to conventional drugs because natural products are considered to be low risk products [19].”
Background
- Authors
- Jordan, S. A., Cunningham, D. G., & Marles, R. J.
- Affiliations
- Health Canada (CA)
- Corresponding author
- Jordan, Scott A.
- ORCID
- Marles, Robin J.
- Venue
- Toxicology and Applied Pharmacology
- Publisher
- Elsevier BV
- Published
- 2010-03
- Volume
- 243
- Issue
- 2
- Pages
- 198-216
- ISSN
- 0041-008X (ISSN-L)
- OpenAlex
- W1985520015
- Cited by
- 415
- References
- 186
- Citations by year
- 2026: 11 · 2025: 24 · 2024: 33 · 2023: 26 · 2022: 30 · 2021: 34 · 2020: 20 · 2019: 25 · 2018: 30 · 2017: 21 · 2016: 27 · 2015: 28 · 2014: 31 · 2013: 25 · 2012: 22
- FWCI
- 3.08
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Toxicology and Applied Pharmacology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Health Canada
- Topics
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Life Sciences › Agricultural and Biological Sciences › Plant Science › Phytochemistry Medicinal Plant Applications
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Plant Toxicity and Pharmacological Properties
- Keywords
- herbal medicinal products, safety assessment, adverse drug reactions, pharmacovigilance databases, predictive toxicology, omics, plant misidentification, herb-drug interactions, Aristolochia, aristolochic acid, regulatory decision-making
- MeSH terms
- Animals, Computer Simulation, Documentation, Humans, Predictive Value of Tests, Quality Control, Safety, Risk Assessment, Plant Preparations, Aristolochia
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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