Adulteration of Purported Herbal and Natural Sexual Performance Enhancement Dietary Supplements with Synthetic Phosphodiesterase Type 5 Inhibitors

摘要: Abstract Introduction Many products labeled “herbal” or “all natural” (herbal/natural) that claim to enhance sexual performance and imply use for the treatment of erectile dysfunction (ED) are marketed as over-the-counter (OTC) dietary supplements. However, adulteration with undeclared phosphodiesterase type 5 (PDE5) inhibitors appears widespread. Aim To assess availability, cost, origin, categorical content, PDE5 purported herbal/natural OTC supplements claiming naturally performance. Methods Pfizer Global Security coordinated sample collection (all from convenience stores filling stations in two U.S. metropolitan areas except seven Customs seizures) liquid chromatography/mass spectrometry examination. Main Outcome Measure Adulteration synthetic inhibitors. Results Ninety-one samples 58 distinct priced $2.99 $17.99 were evaluated. Origin/manufacture was claimed United States (n = 62), apparently Asian (n = 15), not clearly identified (n = 14). Although no include substances, 74 (81%) contained PDE5-inhibitor pharmaceutical ingredients, including tadalafil and/or sildenafil (n = 40, which 18 >110% highest approved drug product strength) analogs (n = 34). Pronounced heterogeneity contents between within individual indicated minimal quality control during manufacture. Labeling inadequate (e.g., lacking lot number expiry date) 17 (23 samples) inconsistent a given manufacturer, number, having multiple samples. Only 14 warned against concomitant nitrate use. Conclusions Ethical companies concerned an unsuspecting public when their counterfeited, mislabeled, illegally offered sale unsafe manner. Because dangers inhibitors, absent safety warnings, lack consistent manufacture, men ED unknowingly risk health by using Campbell N, Clark JP, Stecher VJ, Thomas JW, Callanan AC, Donnelly BF, Goldstein I, Kaminetsky JC. herbal natural enhancement