Forensic and Legal Aspect of the Contents of Herbal and Supplementary Products
DOI:
https://doi.org/10.17986/blm.2014191770Keywords:
herbal products, sibutramine, dietary supplements in sport, cinnarizine, gc-msAbstract
There is an increasing interest in herbal products as alternative or supplementary methods of conventional treatments recently. These products are marketed under the licensed as food supplements by Ministry of Food, Agriculture and Livestock and marketed under the name of herbal therapuetics. Since they are not in the drug product status, licensing procedures and marketing can be varied. The most common problems observed in these products are as the risk of contamination, additives, toxicity and standardization of dose and accuracy of labeling.
Direct intoxications related with these products as well as adverse effects due to drug interactions are observed recently. Under these circumstances it was shown that there is a need about serious regulations and practice on manufacturing, licensing, sale and supervision of the herbal products offered to the market under the name of alternative or supplementary products.
The purpose of this study was to present our findings obtained from three cases consist of two unlicensed herbal products and one licensed sport supplement, which were admitted to our laboratory for content analysis and to evaluate the provisions of the Turkish Criminal Code according to related cases.
Keywords: Herbal products, Sibutramine, Dietary Supplements in Sport, Cinnarizine, GC-MS
Downloads
References
Kupiec T, Raj V. Fatal seizures due to potential herb-drug interactions with Ginkgo biloba. J Anal Toxicol 2005;29:755-758. DOI: https://doi.org/10.1093/jat/29.7.755
Eroglu E, Gemici G, Bayrak F, Kalkan AK, Degertekin M. Acute myocardial infarction in a 24 year-old man possibly associated with sibutramine use. Int J Cardiol 2009;137:e43-45. DOI: https://doi.org/10.1016/j.ijcard.2008.06.017
Daglioglu N, Akcan R. High Dosage Sibutramine Detected in Chinese Herbal Drug. Nobel Med 2012; 8(1):100-102
Kronstrand R, Roman M, Thelander G, Eriksson A. Unintentional fatal intoxications with mitragynine and O-desmethyltramadol from the herbal blend Krypton. J Anal Toxicol 2011;35:242-247. DOI: https://doi.org/10.1093/anatox/35.4.242
Lau G, Lo DS, Yao YJ, Leong HT, Chan CL, Chu SS. A fatal case of hepatic failure possibly induced by nitrosofenfluramine: a case report. Med Sci Law. 2004;44(3):252-263. DOI: https://doi.org/10.1258/rsmmsl.44.3.252
WHO Geneva Meeting Report. 1972, http://whqlibdoc.who.int/trs/WHO_TRS_498.pdf (Erişim tarihi: 13.06.2014)
İlaç Sanayii Özel İhtisas Komisyonu Raporu, Sekizinci Beş Yıllık Kalkınma Planı, Ankara 2001, 1. ISBN 975-19-2569-X, www.surdurulebilirkalkinma.gov.tr/DocObjects/Download/.../oik556.pdf (Erişim tarihi: 13.06.2014)
Şencan N. Eczacının İlaç Üzerindeki Sorumluluk ve Zorunlulukları. İlaç ve Tıp Alanında Ceza Hukuku, Etik ve Tıbbi Sorunlar Sempozyumu, Yeditepe Üniversitesi Hukuk Fakültesi, İstanbul, 8 Ekim 2008, s. 167.
Doğan C. İlaç Kullanımından Ortaya Çıkan Zararlardan Cezai Sorumluluk, II.Sağlık Hukuku Kurultayı, 7-8 Kasım 2008 Ankara, Ankara Barosu Yayınları 2009, 411-455.
Başaran A. Ülkemizdeki bitkisel ilaçlar ve ürünlerde yasal durum. MİSED, 2012; 27-28: 22-26.
Coskun M, Goker AH. Bitkisel ürünlerde analizin önemi, MİSED, 2012;27-28:30-34.
Luque CA, Rey JA. The discovery and status of sibutramine as an anti-obesity drug. Eur J Pharmacol 2002;440:119-128. DOI: https://doi.org/10.1016/S0014-2999(02)01423-1
Nisoli E, Carruba MO. A benefit-risk assessment of sibutramine in the management of obesity. Drug Safety 2003;26(14):1027-1048. DOI: https://doi.org/10.2165/00002018-200326140-00004
The World Anti-Doping Code (2006) The 2006 prohibited list international standard. World Anti-Doping Agency, Montreal. www.wada-ama.org. (Son erişim tarihi: 13.06.2013)
Consumer directed questions and answers about FDA’s initiative against contaminated weight loss products. http://www.fda.gov/drugs/resourcesforyou/consumers/questionsanswers/ucm136187.htm (Erişim tarihi: 13.06.2014)
Müller D, Weinmann W, Hermanns-Clausen M. Chinese slimming capsules containing sibutramine sold over the Internet: a case series. Deutsches Arzteblatt International 2009;106 (13):218-222. DOI: https://doi.org/10.3238/arztebl.2009.0218
Weight loss products recalled, http://www.webmd.com/diet/news/20090422/34-weight-loss-products-recalled (Erişim tarihi: 13.06.2014)
Fake Alli diet pills can pose health risks, http://edition.cnn.com/2010/HEALTH/01/23/fake.diet.drug/index.html (Erişim tarihi: 13.06.2014)
Vidal C, Quandte S. Identification of a Sibutramine-metabolite in Patient Urine After Intake of a “Pure Herbal” Chinese Slimming Product. Ther Drug Monit 2006;28(5):690-692. DOI: https://doi.org/10.1097/01.ftd.0000245392.33305.b0
Phattanawasin P, Sotanaphun U, Sukwattanasinit T, Akkarawaranthorn J, Kitchaiya S. Quantitative determination of sibutramine in adulterated herbal slimming formulations by TLC-image analysis method. Forensic Sci Int 2012;219(1-3):96-100. DOI: https://doi.org/10.1016/j.forsciint.2011.12.004
Ramakrishna V. S. Nirogi, Vishwottam Kandikere, Manoj Shukla, Koteshwara Mudigonda, Santosh Maurya, Sensitive and reproducible liquid chromatography-tandem mass spectrometry method for quantification of sibutramine in human plasma, Forensic Toxicology 2007;25(1):30-36. DOI: https://doi.org/10.1007/s11419-007-0024-8
Ding L, Hao X, Huang X, Zhang S. Simultaneous determination of sibutramine and its N-desmethyl metabolitesin human plasma by liquid chromatography-electrospray ionization-mass spectrometry method and clinical applications. Anal Chim Acta 2003;492:241-248. DOI: https://doi.org/10.1016/S0003-2670(03)00209-5
Ariburnu E, Uludag MF, Yalcinkaya H, Yesilada E. Comparative determination of sibutramine as an adulterant in natural slimming products by HPLC and HPTLC densitometry. J Pharm Biomed Anal 2012;64-65:77-81. DOI: https://doi.org/10.1016/j.jpba.2012.02.004
Strano-Rossi S, Colamonici C, Botre F. Detection of sibutramine administration: a Gas Chromatography/Mass Spectrometry study of the main urinary metabolites. Rapid Commun Mass Spectrom 2007;21:79-88. DOI: https://doi.org/10.1002/rcm.2807
Mercan S. Adli farmakogenetikte CYP2D6 polimorfizminin önemi, Doktora Tezi, , İstanbul Üniversitesi Adli Tıp Enstitüsü, 2012.
Da Rocha MS1, Dodmane PR, Arnold LL, Pennington KL, Anwar MM, Adams BR, Taylor SV, Wermes C, Adams TB, Cohen SM. Mode of action of pulegone on the urinary bladder of F344 rats. Toxicol Sci 2012;128(1):1-8. DOI: https://doi.org/10.1093/toxsci/kfs135
Topçu G, Yapar G, Türkmen Z, Gören AC, Öksüz S, Schilling JK, Kingston DGI. Ovarian antiproliferative activity directed isolation of triterpenoids from fruits of Eucalyptus camaldulensis Dehnh. Phytochemistry Letters 2011; 4:421–425. DOI: https://doi.org/10.1016/j.phytol.2011.05.002
Deka CVR. Role of Cinnarizine in Peripheral Vertigo. Vertigo Viewpoint 2006;4(1):2-4.
Nicholson AN, Stone BM, Turner C, Mills SL. Central effects of cinnarizine: Restricted use in aircrew. Aviation, Space, and Environmental Medicine 2002;73(6):570-574.
Teive HLAG, Troiano AR, Germiniani FMB, Werneck LC. Flunarizine and cinnarizine-induced parkinsonism: A historical and clinical analysis. Parkinsonism & Related Disorders 2004;10(4):243-245. DOI: https://doi.org/10.1016/j.parkreldis.2003.12.004
Turner D, Lurie Y, Finkelstein Y, Schmid T, Gopher A, Kleid D, Bentur Y. Pediatric cinnarizine overdose and toxicokinetics. Pediatrics 2006;117(5):e1067-e1069. DOI: https://doi.org/10.1542/peds.2005-2059
Ersoz T. Bitkisel ilaçlar ve gıda takviyeleri ile ilgili genel yaklaşım ve sorunlar. MİSED, 2012;27-28: 11-21.
Örgen N. Araştırmacı İlaç Firmaları Derneği (AIFD) Genel Sekreterliği, Hürses Gazetesi 2007.
http://www.havanhaber.org/?page=basindan&basindan_ID=2193 (Erişim tarihi: 13.06.2014)
Altunkaş A. Kişilerin hayatını ve sağlığını tehlikeye sokacak biçimde ilaç yapma veya satma suçu (TCK m. 187) Marmara Üniversitesi Hukuk Fakültesi, Hukuk Araştırmaları Dergisi, 2013;19(2):829-870.
Blacksell L, Byard RW, Musgrave IF. Forensic problems with the composition and content of herbal medicines. J Forensic Leg Med. 2014:23;19-21. DOI: https://doi.org/10.1016/j.jflm.2014.01.008
Downloads
Published
Issue
Section
License
The Journal and content of this website is licensed under the terms of the Creative Commons Attribution (CC BY) License. The Creative Commons Attribution License (CC BY) allows users to copy, distribute and transmit an article, adapt the article and make commercial use of the article. The CC BY license permits commercial and non-commercial re-use of an open access article, as long as the author is properly attributed.