- Email: [email protected]
Pattern and trend of pharmaceutical adulteration of Chinese herbs and dietary supplements in Taiwan: Roles of the Taiwan FDA
Abstracts / Toxicology Letters 259S (2016) S4–S62
S31-2 Pattern and trend of pharmaceutical adulteration of Chinese herbs and dietary supplements in Taiwan: Roles of the Taiwan FDA C.C. Yang Institute of Environmental & Occupational Sciences, National Yang-Ming University; Division of Clinical Toxicology & Occupational Medicine, Taipei Veterans General Hospital, Taipei, Taiwan Introduction: Chinese herbal medicines (CHMs) and dietary supplements are commonly used worldwide, including Taiwan. However, pharmaceutical adulteration has been repeatedly found in certain CHMs and dietary supplements. Objective: To describe the pattern and trend of pharmaceutical adulteration of CHMs and dietary supplements in Taiwan and the role of Taiwan FDA (TFDA) in managing such a problem. Methods: To curb the problem of pharmaceutical adulteration of CHMs and dietary supplements, TFDA has analyzed samples of CHMs and dietary supplements collected primarily by local health departments for the presence of adulterants annually since 1983. All samples were analyzed by TLC, GC/MS, LC/MS/MS and were categorized as positive for adulterants when both TLC and GC/MS tests or when LC/MS/MS test was positive. Relevant statistic data were published annually. We reviewed all reports published by TFDA between 2005 and 2014 and reanalyzed certain data to understand the pattern and trend of adulteration of CHMs and dietary supplements in Taiwan. Results: The prevalence of adulteration of CHMs ranged between 9.1% and 24.9% during the study period. CHMs claimed to have health promotion, aphrodisiac or analgesic effects were more likely to be adulterated. Moreover, non-prescribed CHMs were more likely to be adulterated (11.6–37.6%) than prescribed CHMs (1.4–10.9%). Among numerous adulterants, sildenafil, caffeine, hydrochlorothiazide and various analgesics were frequently listed as the top 5 adulterants. As for dietary supplements, the prevalence of adulteration spanned from 14.5% to 40.0% and showed a decreasing trend during the study period. Dietary supplements claimed to have weight loss or aphrodisiac function were more likely to be adulterated, with sildenafil, sibutramine, phenolphthalein, caffeine and tadalafil being the top 5 adulterants. Conclusions: The prevalence of pharmaceutical adulteration of CHMs and dietary supplements was decreasing in Taiwan. However, adulteration of non-prescribed CHMs and specific dietary supplements remained common. More efforts are needed to further ameliorate the problem. http://dx.doi.org/10.1016/j.toxlet.2016.07.138 S31-3 A review of heavy metal levels in herbal supplements R. Lemus-Olalde a,b a b
Advanced Testing Laboratory Inc, Cincinnati, OH, USA International Tungsten Industry Association, London, UK
Introduction: Many herbal supplements have clean safety histories. However, products like herbs are sometimes tainted with toxic or essential metals, as plants can uptake heavy metals such as zinc, copper, nickel, cadmium, iron, and manganese from the soil in which they grow and tend to accumulate the metals in their leaves, roots, stem and/or flowers. Previously, in 2004 the Journal of the American Medical Association reported that about 20% of
S57
herbal supplements sampled contained high levels of heavy metals (such as lead, mercury, and arsenic) to potentially produced adverse effects. Therefore, it is essential to know that herbal supplements originate “from nature” and this does not mean that they are safe and/or with no potential harmful effects and/or toxicity. Objective: In this presentation, we report heavy metal levels of several herbal supplements investigations and potential risks associated with the intake of self-prescribed supplements. Methods: PubMed® (http://www.ncbi.nlm.nih.gov/pubmed) literature searches were conducted using the following (herbal[All Fields] AND supplements[All Fields]) AND (“metals”[MeSH Terms] OR “metals”[All Fields]). A subsequent systematic approach to evaluate the quality of data and their use in hazard and risk assessment was conducted according to Klimisch et al. (1997). Results: The literature search yielded 53 peer review publications, of these 29 articles were considered relevant. The metals most detected in herbal products were aluminum, arsenic, barium, cadmium, cobalt, chromium, copper, iron, lanthanum, lead, lithium, manganese, mercury, methyl mercury, molybdenum, nickel, selenium, strontium, vanadium, and zinc. In some herbal supplements the heavy metal levels were present in significant quantities, and if taken as directed, would expose a person to more of the metals than is deemed safe by regulatory agencies. Discussion: Heavy metals may enter into the herbal supplement manufacturing process via bioaccumulation from the harvest site or during postharvest processing phases. Overall, it is essential to guarantee the safety of herbal supplements if consumers’ health is to be protected. Although herbal supplements and their preparations are regulated at some degree, accurate data concerning the finished products and the herb used as the starting point are of major importance if risks and safety are to be properly assessed. Physiologically active as well as potentially toxic constituents and/or impurities need to be identified and measured. At the end, it remains the duty of manufacturers to provide sufficient safety information to consumers. http://dx.doi.org/10.1016/j.toxlet.2016.07.139 S31-4 Adulteration of dietary supplements with drugs and drug analogs: What makes NMR? M. Malet-Martino Groupe de RMN Biomédicale, Laboratoire SPCMIB (UMR CNRS 5068), Université Paul Sabatier, 118 route de Narbonne, 31062 Toulouse, France Introduction: The illegal addition of undeclared synthetic compounds to dietary supplements (DS) is a serious problem. DS subject to adulteration are mainly those used for sexual enhancement (SE), weight loss (WL) and muscle building. NMR spectroscopy is a unique tool for the analysis of complex mixtures. Objective: Due to cost constraints, NMR is rarely used in routine quality control (QC) analysis. The purpose of the present study is to discuss the pros and cons of the technique for the screening of SE and WL DS for synthetic adulterants. Materials and methods: 250 SE DS and 175 WL DS mainly purchased on the Internet and claimed as 100% natural were analyzed. 1 H NMR at high field (500 MHz) was used for detecting, identifying and quantifying the adulterant(s). 16 DS were also analyzed on a benchtop cryogen-free low-field NMR spectrometer (60 MHz). Results: More than 60% of the SE DS were adulterated mostly with phosphodiesterase-5 inhibitors (PDE-5i) medicines and/or their structural analogs. Several SE DS contained mixtures of 2, 3 and even 4 PDE-5i. Approximately half of the WL DS contained
S31-2 Pattern and trend of pharmaceutical adulteration of Chinese herbs and dietary supplements in Taiwan: Roles of the Taiwan FDA C.C. Yang Institute of Environmental & Occupational Sciences, National Yang-Ming University; Division of Clinical Toxicology & Occupational Medicine, Taipei Veterans General Hospital, Taipei, Taiwan Introduction: Chinese herbal medicines (CHMs) and dietary supplements are commonly used worldwide, including Taiwan. However, pharmaceutical adulteration has been repeatedly found in certain CHMs and dietary supplements. Objective: To describe the pattern and trend of pharmaceutical adulteration of CHMs and dietary supplements in Taiwan and the role of Taiwan FDA (TFDA) in managing such a problem. Methods: To curb the problem of pharmaceutical adulteration of CHMs and dietary supplements, TFDA has analyzed samples of CHMs and dietary supplements collected primarily by local health departments for the presence of adulterants annually since 1983. All samples were analyzed by TLC, GC/MS, LC/MS/MS and were categorized as positive for adulterants when both TLC and GC/MS tests or when LC/MS/MS test was positive. Relevant statistic data were published annually. We reviewed all reports published by TFDA between 2005 and 2014 and reanalyzed certain data to understand the pattern and trend of adulteration of CHMs and dietary supplements in Taiwan. Results: The prevalence of adulteration of CHMs ranged between 9.1% and 24.9% during the study period. CHMs claimed to have health promotion, aphrodisiac or analgesic effects were more likely to be adulterated. Moreover, non-prescribed CHMs were more likely to be adulterated (11.6–37.6%) than prescribed CHMs (1.4–10.9%). Among numerous adulterants, sildenafil, caffeine, hydrochlorothiazide and various analgesics were frequently listed as the top 5 adulterants. As for dietary supplements, the prevalence of adulteration spanned from 14.5% to 40.0% and showed a decreasing trend during the study period. Dietary supplements claimed to have weight loss or aphrodisiac function were more likely to be adulterated, with sildenafil, sibutramine, phenolphthalein, caffeine and tadalafil being the top 5 adulterants. Conclusions: The prevalence of pharmaceutical adulteration of CHMs and dietary supplements was decreasing in Taiwan. However, adulteration of non-prescribed CHMs and specific dietary supplements remained common. More efforts are needed to further ameliorate the problem. http://dx.doi.org/10.1016/j.toxlet.2016.07.138 S31-3 A review of heavy metal levels in herbal supplements R. Lemus-Olalde a,b a b
Advanced Testing Laboratory Inc, Cincinnati, OH, USA International Tungsten Industry Association, London, UK
Introduction: Many herbal supplements have clean safety histories. However, products like herbs are sometimes tainted with toxic or essential metals, as plants can uptake heavy metals such as zinc, copper, nickel, cadmium, iron, and manganese from the soil in which they grow and tend to accumulate the metals in their leaves, roots, stem and/or flowers. Previously, in 2004 the Journal of the American Medical Association reported that about 20% of
S57
herbal supplements sampled contained high levels of heavy metals (such as lead, mercury, and arsenic) to potentially produced adverse effects. Therefore, it is essential to know that herbal supplements originate “from nature” and this does not mean that they are safe and/or with no potential harmful effects and/or toxicity. Objective: In this presentation, we report heavy metal levels of several herbal supplements investigations and potential risks associated with the intake of self-prescribed supplements. Methods: PubMed® (http://www.ncbi.nlm.nih.gov/pubmed) literature searches were conducted using the following (herbal[All Fields] AND supplements[All Fields]) AND (“metals”[MeSH Terms] OR “metals”[All Fields]). A subsequent systematic approach to evaluate the quality of data and their use in hazard and risk assessment was conducted according to Klimisch et al. (1997). Results: The literature search yielded 53 peer review publications, of these 29 articles were considered relevant. The metals most detected in herbal products were aluminum, arsenic, barium, cadmium, cobalt, chromium, copper, iron, lanthanum, lead, lithium, manganese, mercury, methyl mercury, molybdenum, nickel, selenium, strontium, vanadium, and zinc. In some herbal supplements the heavy metal levels were present in significant quantities, and if taken as directed, would expose a person to more of the metals than is deemed safe by regulatory agencies. Discussion: Heavy metals may enter into the herbal supplement manufacturing process via bioaccumulation from the harvest site or during postharvest processing phases. Overall, it is essential to guarantee the safety of herbal supplements if consumers’ health is to be protected. Although herbal supplements and their preparations are regulated at some degree, accurate data concerning the finished products and the herb used as the starting point are of major importance if risks and safety are to be properly assessed. Physiologically active as well as potentially toxic constituents and/or impurities need to be identified and measured. At the end, it remains the duty of manufacturers to provide sufficient safety information to consumers. http://dx.doi.org/10.1016/j.toxlet.2016.07.139 S31-4 Adulteration of dietary supplements with drugs and drug analogs: What makes NMR? M. Malet-Martino Groupe de RMN Biomédicale, Laboratoire SPCMIB (UMR CNRS 5068), Université Paul Sabatier, 118 route de Narbonne, 31062 Toulouse, France Introduction: The illegal addition of undeclared synthetic compounds to dietary supplements (DS) is a serious problem. DS subject to adulteration are mainly those used for sexual enhancement (SE), weight loss (WL) and muscle building. NMR spectroscopy is a unique tool for the analysis of complex mixtures. Objective: Due to cost constraints, NMR is rarely used in routine quality control (QC) analysis. The purpose of the present study is to discuss the pros and cons of the technique for the screening of SE and WL DS for synthetic adulterants. Materials and methods: 250 SE DS and 175 WL DS mainly purchased on the Internet and claimed as 100% natural were analyzed. 1 H NMR at high field (500 MHz) was used for detecting, identifying and quantifying the adulterant(s). 16 DS were also analyzed on a benchtop cryogen-free low-field NMR spectrometer (60 MHz). Results: More than 60% of the SE DS were adulterated mostly with phosphodiesterase-5 inhibitors (PDE-5i) medicines and/or their structural analogs. Several SE DS contained mixtures of 2, 3 and even 4 PDE-5i. Approximately half of the WL DS contained