PhytoAuthent: Molecular authentication of complex herbal food supplements for safety and efficacy

Ichim, Mihael Cristin; Crișan, Gianina; Ţebrencu, Carmen Elena; Boer, Hugo de

doi:10.3897/rio.4.e26986

Cited by 4 publications

(3 citation statements)

References 5 publications

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“…When Saint John’s wort ( Hypericum perforatum L.) was an ingredient in 78 herbal products sold in 14 European countries, DNA metabarcoding has identified the species in only 68% of the 38 products successfully analyzed, but incongruence between constituent species and those listed on the label was detected in all products (Raclariu et al, 2017). Unfortunately, the scale of all the investigations is restrained to a specific geographical area, national or regional market, types of products, target plant species, product specific use or detection method (Ichim et al, 2018).…”

Section: Discussionmentioning

confidence: 99%

The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally Widespread Adulteration

Ichim

2019

Front. Pharmacol.

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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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Section: Discussionmentioning

confidence: 99%

The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally Widespread Adulteration

Ichim

2019

Front. Pharmacol.

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“…Application of a DNA method only as a QC tool is not recommended due to the lack of specificity; DNA methods are recommended for detection of species substitution or falsification [83]. Constituents of interest or identity markers are not recommended to be applied as BIM of any herbs; this is also due to the lack of specificity.…”

Section: Conclusion and Recommendationsmentioning

confidence: 99%

Recent Development of Quality Control Methods for Herbal Derived Drug Preparations

Indrayanto

2018

Natural Product Communications

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Pharmaceutical industries should apply rigorous QC (quality control) to ensure the consistency, safety, and efficacy of their herbal derived drug-preparations. QC must be performed at every stage of the production line i.e. incoming raw materials, extractions, in-process control, finished products and keeping samples. Due to the complex nature of the chemical content of herbal drugs, two approaches to QC should be taken, that is quantitative determination of the selected marker(s) compound(s), and metabolite profiling. Contamination of herbal medicines by heavy metals, pesticides, toxic metabolites, microbial toxins, pathogenic microorganisms and other foreign matter should also be evaluated. A combination of chemical profiling and multivariate analysis (MVA) is recommended as the QC tool for the botanical identification method (BIM) of herbs, extracts, herb materials, and herbal drug preparations. Microscopic methods, DNA profiling or chemical marker(s) are not recommended for use as the sole BIM due to the lack of specificity. Only markers that meet certain criteria i.e. quality active (QA) markers can be utilized as a QC tool. The limit specification range of markers used as QC tools should be described in the analytical target profile (ATP). To gain reliable results of any analysis that has been performed at any QC laboratory, the analysis method must be validated according to the newest guidance. Sample detection limit of any toxic compound(s) should be lower than its cutoff value and MPL. The reliability of any results of analysis of a QC laboratory must be evaluated by using QC-samples for each series of measurements.

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“…The global market for herbal products is rapidly expanding and expected to reach 115,000 million US$ in 2020 (Raclariu et al, 2018a) while the trade of medicinal plants will continue to advance with annual growth rates of 15-25% (Booker et al, 2012). This increasing demand for plant-based products has resulted in a proportionally increase of peer-reviewed reports of accidental contamination or intentional, economically motivated adulteration (de Boer et al, 2015;Ichim et al, 2018;Simmler et al, 2018;Grazina et al, 2020;Grosu and Ichim, 2020). A global analysis of nearly 6,000 herbal products sold in 37 countries has revealed that 27% of the products contain undeclared contaminants, substitutes, or filler species (Ichim, 2019).…”

Section: Introductionmentioning

confidence: 99%

Microscopic Authentication of Commercial Herbal Products in the Globalized Market: Potential and Limitations

2020

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Herbal products are marketed and used around the globe for their claimed or expected health benefits, but their increasing demand has resulted in a proportionally increase of their accidental contamination or intentional adulteration, as already confirmed with DNAbased methods. Microscopy is a traditional pharmacopoeial method used for plant identification and we systematically searched for peer-reviewed publications to document its potential and limitations to authenticate herbal medicines and food supplements commercially available on the global market. The overall authenticity of 508 microscopically authenticated herbal products, sold in 13 countries, was 59%, while the rest of 41% were found to be adulterated. This problem was extending over all continents. At the national level, there were conspicuous differences, even between neighboring countries. These microscopically authenticated commercial herbal products confirm that different magnifying instruments can be used to authenticate crude or processed herbal products traded in the global marketplace. The reviewed publications report the successful use of different magnifying instruments, single or in combinations with a second one, with or without a chemical or DNA-based technique. Microscopy is therefore a rapid and cost-efficient method, and can cope with mixtures and impurities. However, it has limited applicability for highly processed samples. Microscopic authentication of commercial herbal products will therefore contribute to raise public awareness for the extent of adulteration and the need to safeguard consumer safety against the challenges of globalization.

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PhytoAuthent: Molecular authentication of complex herbal food supplements for safety and efficacy

Cited by 4 publications

References 5 publications

The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally Widespread Adulteration

The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally Widespread Adulteration

Recent Development of Quality Control Methods for Herbal Derived Drug Preparations

Microscopic Authentication of Commercial Herbal Products in the Globalized Market: Potential and Limitations

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