The safety, efficacy and pharmaceutical quality of male enhancement nutraceuticals bought online: Truth versus claim

Nounou, 2018, Adulteration and counterfeiting of online nutraceutical formulations in the United States: time for intervention?, J Diet Suppl, 15, 789, 10.1080/19390211.2017.1360976 Andrew, 2017, Principles of pharmacological research of nutraceuticals, Br J Pharmacol, 174, 1177, 10.1111/bph.13779 Amine, 2019, Are male enhancement ultraceuticals sold online safe, natural and compliant with their label claim?, J Sexual Med Reprod Health, 2, 7 Pérez-Sánchez, 2018, Nutraceuticals for skin care: a comprehensive review of human clinical studies, Nutrients, 10, 403, 10.3390/nu10040403 Yafi, 2016, Erectile dysfunction, Nat Rev Dis Primers, 2, 16003, 10.1038/nrdp.2016.3 ElAgouri, 2015, Male enhancement nutraceuticals in the Middle East market: claim, pharmaceutical quality and safety assessments, Int J Pharm, 492, 109, 10.1016/j.ijpharm.2015.07.006 Santini, 2018, Nutraceuticals: opening the debate for a regulatory framework, Br J Clin Pharmacol, 84, 659, 10.1111/bcp.13496 Ahmed, 2019, Over-the-counter herbal weight loss supplements in Egypt: label claim, microbiological and pharmaceutical quality, and safety assessments, Med Princ Pract, 28, 167, 10.1159/000495986 Kottke, 1998, Scientific and regulatory aspects of nutraceutical products in the United States, Drug Dev Ind Pharm, 24, 1177, 10.3109/03639049809108576 Koch, 2014, The need for a legal distinction of nutraceuticals, Food Nutr Sci, 5, 905 Umegaki K. Chapter 65–regulatory aspects of nutraceuticals: Japanese perspective. In: Gupta RC, editor. Nutraceuticals. Boston: Academic Press; 2016; 933–40. Helal, 2019, Nutraceuticals’ novel formulations: the good, the bad, the unknown and patents involved, Recent Pat Drug Deliv Formul, 13, 105, 10.2174/1872211313666190503112040 FDA. Coronavirus update: FDA and FTC warn seven companies selling fraudulent products that claim to treat or prevent COVID-19. (2020-03-09) [2020-03-31]. https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-and-ftc-warn-seven-companies-selling-fraudulent-products-claim-treat-or. European Medicines Agency. COVID-19: Beware of falsified medicines from unregistered Websites. (2020-03-24) [2020-03-31]. https://www.ema.europa.eu/en/news/covid-19-beware-falsified-medicines-unregistered-websites. Zailina, 2013, Optimization of extraction methods for determination of phosphodiesterase-5 (PDE5) inhibitors in premix coffee, Sains Malays, 42, 135 Vredenbregt, 2006, Screening suspected counterfeit Viagra and imitations of Viagra with near-infrared spectroscopy, J Pharm Biomed Anal, 40, 840, 10.1016/j.jpba.2005.07.048 Suñé-Negre J, Garcia E, Lozano P, Díaz J, Carreras M, Fuster R, et al. SeDeM Diagram: a new expert system for the formulation of drugs in solid form. (2011-10-10) [2020-03-21]. https://www.intechopen.com/books/expert-systems-for-human-materials-and-automation/sedem-diagram-a-new-expert-system-for-the-formulation-of-drugs-in-solid-form. Razak, 2011, Toxicity studies of Eurycoma longifolia (JACK) based remedial products, Asian J Pharm Clin Res, 4, 23 Shahin, 2019, Design and evaluation of novel inhalable sildenafil citrate spray-dried microparticles for pulmonary arterial hypertension, J Control Release, 302, 126, 10.1016/j.jconrel.2019.03.029 Nowak, 2018, ATP-based cell viability assay is superior to trypan blue exclusion and XTT assay in measuring cytotoxicity of anticancer drugs Taxol and Imatinib, and proteasome inhibitor MG-132 on human hepatoma cell line HepG2, Clin hemorheol microcirculation, 69, 327, 10.3233/CH-189120 Vakili Zahir, 2018, Evaluation of silibinin effects on the viability of HepG2 (human hepatocellular liver carcinoma) and HUVEC (human umbilical vein endothelial) cell lines, Iran J Pharm Res, 17, 261 Ohtsu, 2017, Advanced glycation end products and lipopolysaccharides stimulate interleukin-6 secretion via the RAGE/TLR4-NF-κB-ROS pathways and resveratrol attenuates these inflammatory responses in mouse macrophages, Exp Ther Med, 14, 4363 Roe, 1993, HepG2 cells: an in vitro model for P450-dependent metabolism of acetaminophen, Biochem Biophys Res Commun, 190, 15, 10.1006/bbrc.1993.1003 Kumar, 2018, Analysis of cell viability by the lactate dehydrogenase assay, Cold Spring Harb Protoc, 2018 Amazon Inc. Golden X Pill. [2020-04-05]. https://www.amazon.com/Golden-Pill-Count-Bottle-Enhancement/dp/B07CQRCC52. Amazon Inc. Prime Test. (2016-10-27) [2020-04-05]. https://www.amazon.com/Prime-Labs-Booster-Endurance-Strength/dp/B01MQ1JLWY Amazon Inc. Horny goat weed herbal complex. (2015-09-09) [2020-04-05]. https://www.amazon.com/Complex-Capsules-Performance-Natures-Design/dp/B0154O5FYC/ref=sr_1_5_a_it?ie=UTF8&qid=1547858463&sr=8-5&keywords=male%2Benhancing%2Bpills%2Berection%2Bbest%2Bseller&th=1. Amazon Inc. Organic Maca root powder capsules. (2017-12-30) [2020-04-05] https://www.amazon.com/Organic-Maca-Root-Powder-Capsules/dp/B078QFDG3Z/ref=sr_1_28_a_it?ie=UTF8&qid=1548128274&sr=8-28&keywords=male+enhancing+pills. Wang, 2008, Analysis of six synthetic adulterants in herbal weight-reducing dietary supplements by LC electrospray ionization-MS, Food Addit Contam Part A Chem Anal Control Expo Risk Assess, 25, 822, 10.1080/02652030801946553 Kim, 2013, New advances in models and strategies for developing anti-obesity drugs, Expert Opin Drug Discovy, 8, 655, 10.1517/17460441.2013.792804 Boolell, 1996, Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction, Int J Impot Res, 8, 47 Corbin, 2004, Mechanisms of action of PDE5 inhibition in erectile dysfunction, Int J Impot Res, 16, S4, 10.1038/sj.ijir.3901205 Carson, 2004, Erectile dysfunction: evaluation and new treatment options, Psychosom Med, 66, 664, 10.1097/01.psy.0000133969.80612.71 He, 2010, Icaritin induces apoptosis of HepG2 cells via the JNK1 signaling pathway independent of the estrogen receptor, Planta Med, 76, 1834, 10.1055/s-0030-1250042 Li, 2012, Purification, characterization and anticancer activity of a polysaccharide from Panax ginseng, Int J Biol Macromol, 51, 968, 10.1016/j.ijbiomac.2012.06.031 Yadav, 2014, Cytotoxicity of different extracts of Mucuna pruriensseeds on hepatoma cells but not on normal hepatic cells, Pharmacog Commn, 5, 75, 10.5530/pc.2015.1.6 Pullirsch, 2014, Microbiological contamination in counterfeit and unapproved drugs, BMC Pharmacol Toxicol, 15, 34, 10.1186/2050-6511-15-34 Walther, 2016, Microbial contamination of traditional liquid herbal medicinal products marketed in Mwanza city: magnitude and risk factors, Pan Afr Med J, 23, 65, 10.11604/pamj.2016.23.65.7917 Ganesan, 2016, Majoon ushba, a polyherbal compound ameliorates rheumatoid arthritis via regulating inflammatory and bone remodeling markers in rats, Cytokine, 77, 115, 10.1016/j.cyto.2015.11.002 Elberry, 2014, Immunomodulatory effect of red onion (Allium cepa Linn) scale extract on experimentally induced atypical prostatic hyperplasia in Wistar rats, Mediators Inflamm, 2014, 10.1155/2014/640746 Jung, 2011, Effects of Panax Ginseng supplementation on muscle damage and inflammation after uphill treadmill running in humans, Am J Chin Med, 39, 441, 10.1142/S0192415X11008944 Su, 2018, Icariin alleviates murine lupus nephritis via inhibiting NF-κB activation pathway and NLRP3 inflammasome, Life Sci, 208, 26, 10.1016/j.lfs.2018.07.009 Rosenkranz, 2001, Interaction between sildenafil and antihypertensive drugs: what is evidence-based?, Dtsch Med Wochenschr, 126, 1144, 10.1055/s-2001-17743