The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally Widespread Adulteration
Open accessAbstract
The herbal products, sold worldwide as medicines or foods, are perceived as low risk because they are considered natural and thus safe. The quality of these products is ineffectively regulated and controlled. The growing evidence for their lack of authenticity is causing deep concern, but the scale of this phenomenon at the global, continental or national scale remains unknown. We analyzed data reporting the authenticity, as detected with DNA-based methods, of 5,957 commercial herbal products sold in 37 countries, distributed in all six inhabited continents. Our global survey shows that a substantial proportion (27%) of the herbal products commercialized in the global marketplace is adulterated when their content was tested against their labeled, claimed ingredient species. The adulterated herbal products are distributed across all continents and regions. The proportion of adulterated products varies significantly among continents, being highest in Australia (79%), South America (67%), lower in Europe (47%), North America (33%), Africa (27%) and the lowest in Asia (23%). The commercial HPs' authenticity among the 37 countries included in our global analysis ranges between 0 and 100% from the total number of product reported for each specific national marketplace. For 9 countries, more than 100 products were successfully DNA-based authenticated and reported. From these countries, the highest percentage of adulterated commercial HPs was reported for Brazil (68%), followed distantly by Taiwan (32%), India (31%), USA (29%), followed closely by Malaysia (24%), Japan (23%), South Korea (23%), Thailand (20%), and China (19%). Our results confirm the large-scale presence of adulterated herbal products throughout the global market. The adulterated herbal products contain undeclared contaminant, substitute, and filler species, or none of the labeled species, which all may be accidental or intentional, economically-motivated and fraudulent. Due to the ever-increasing analytical sensitivity of the high throughput DNA sequencing, increasingly used for the untargeted, simultaneous multi-taxa identification, the proportion of adulterated HPs detected on the global market is expected to increase. In the context of the increasing demand for HPs, the limited supply of raw materials derived from many plant species, some of which being already nationally or internationally protected and having various degrees of trade restrictions, adds up to the differences and discrepancies between national HPs' regulatory frameworks and further increases the risks of adulteration of many types of herbal products. The globally widespread adulteration is a serious threat to consumers' well-being and safety, in spite of herbal products' claimed or expected health benefits.
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Botanical identity and actual alkaloid content of berberine products vary considerably, and contamination and substitution are documented in botanical products.
“The first is product quality: botanical identity and actual alkaloid content vary considerably, and contamination and substitution are documented in botanical products [32,34].”
From Berberine-Drug Interactions: Mechanisms, Clinical Relevance and Risk Stratification-A Narrative Review (2026) · cites this paper as [34]
The Discussion reports that 27% of successfully analyzed commercial herbal products did not match their claimed composition and describes contamination and substitute species. It does not establish variation in alkaloid content or findings specific to berberine products; searches for those terms found no supporting passage in our copy. No page numbers were provided. (LLM, conf=0.86)
Experimental — accuracy not yet measuredNon-conformity of a significant proportion of marketed berberine products means that the magnitude of any interaction is intrinsically unpredictable without standardization.
“Non-conformity of a significant proportion of marketed products means that the magnitude of any interaction is intrinsically unpredictable without standardization [32,34].”
From Berberine-Drug Interactions: Mechanisms, Clinical Relevance and Risk Stratification-A Narrative Review (2026) · cites this paper as [34]
The Discussion reports that 27% of successfully analyzed commercial herbal products did not match their claimed composition and notes that herbal products can interact with conventional drugs. It does not establish a non-conformity rate for berberine products or say that non-conformity makes the magnitude of an interaction intrinsically unpredictable without standardization. The reported rate applies to herbal products broadly. (LLM, conf=0.86)
Experimental — accuracy not yet measuredNeither direction of product non-conformity can be read off the label, so the defensible position is that the perpetrator dose is unknown.
“Neither direction can be read off the label, so the defensible position is that the perpetrator dose is unknown [2,32,34].”
From Berberine-Drug Interactions: Mechanisms, Clinical Relevance and Risk Stratification-A Narrative Review (2026) · cites this paper as [34]
The Discussion (page not provided) reports that 27% of analyzed herbal products did not match their labeled or expected composition, supporting the concern that a label may not reliably identify what is in a product. It does not assess whether the amount of an interacting ingredient is higher or lower than labeled, or establish that its dose is unknown. (LLM, conf=0.84)
Experimental — accuracy not yet measuredBotanical contamination and substitution are documented through DNA barcoding techniques in botanical products.
“Botanical contamination and substitution are documented through DNA barcoding techniques in botanical products [34].”
From Berberine-Drug Interactions: Mechanisms, Clinical Relevance and Risk Stratification-A Narrative Review (2026) · cites this paper as [34]
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“Neither direction can be read off the label, so the defensible position is that the perpetrator dose is unknown [2,32,34].”
Influential
- Authors
- Ichim, M. C.
- Affiliations
- National Institute of Research and Development for Biological Sciences (RO)
- Corresponding author
- Ichim, Mihael Cristin
- Venue
- Frontiers in Pharmacology
- Publisher
- Frontiers Media SA
- Published
- 2019-10-24
- Volume
- 10
- Pages
- 1227-1227
- ISSN
- 1663-9812 (ISSN-L)
- PMC
- PMC6822544
- OpenAlex
- W2981596060
- Cited by
- 148
- References
- 24
- Citations by year
- 2026: 24 · 2025: 23 · 2024: 24 · 2023: 22 · 2022: 20 · 2021: 24 · 2020: 10 · 2019: 1
- FWCI
- 4.55
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Frontiers in Pharmacology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Identification and Quantification in Food
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Life Sciences › Agricultural and Biological Sciences › Plant Science › Genetically Modified Organisms Research
- Keywords
- herbal medicine adulteration, DNA-based authentication, commercial herbal products, species misidentification, plant identification, herbal product regulation, consumer safety, next-generation sequencing
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