Ichim Mihael Cristin
"Stejarul" Research Centre for Biological Sciences, National Institute of Research and Development for Biological Sciences, Piatra Neamt, Romania.
Front Pharmacol. 2019 Oct 24;10:1227. doi: 10.3389/fphar.2019.01227. eCollection 2019.
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.
这些草药产品作为药品或食品在全球范围内销售，由于被认为是天然的因而安全，所以被视为低风险产品。这些产品的质量监管不力。越来越多证据表明其缺乏真实性，这引发了人们的深切关注，但在全球、各大洲或国家层面，这一现象的规模仍不明确。我们分析了用基于DNA的方法检测的37个国家销售的5957种商业草药产品的真实性数据，这些国家分布在所有六大有人居住的大陆。我们的全球调查显示，当按照标签上声称的成分物种对全球市场上商业化的草药产品进行含量检测时，相当大比例（27%）的产品存在掺假情况。掺假的草药产品分布在各大洲和地区。掺假产品的比例在各大洲之间差异显著，在澳大利亚最高（79%），南美洲（67%），欧洲较低（47%），北美洲（33%），非洲（27%），亚洲最低（23%）。在我们全球分析所涵盖的37个国家中，商业草药产品的真实性从每个特定国家市场报告的产品总数来看，介于0到100%之间。对于9个国家，有超过100种产品通过基于DNA的方法成功鉴定并报告。在这些国家中，掺假商业草药产品报告比例最高的是巴西（68%），其次是台湾（32%）、印度（31%）、美国（29%），紧随其后的是马来西亚（24%）、日本（23%）、韩国（23%）、泰国（20%）和中国（19%）。我们的结果证实了掺假草药产品在全球市场广泛存在。掺假的草药产品含有未申报的污染物、替代物和填充物种，或者根本没有标签上标注的物种，这些情况可能是偶然的，也可能是故意的、出于经济动机的欺诈行为。由于越来越多地用于非靶向、同时进行多分类群鉴定的高通量DNA测序的分析灵敏度不断提高，预计全球市场上检测到的掺假草药产品比例将会增加。在对草药产品需求不断增加的背景下，许多植物物种原材料供应有限，其中一些已经受到国家或国际保护并存在不同程度的贸易限制，这加剧了各国草药产品监管框架之间的差异和不一致，进一步增加了多种草药产品掺假的风险。尽管草药产品声称或预期有健康益处，但全球范围内普遍存在的掺假现象对消费者的健康和安全构成了严重威胁。
