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

Mohamed Ismail Nounou; Heba A Eassa; Nada A Helal; Khaled AboulFotouh; Ihab Mansoor; Isabel K Latz; Cindy Zheng; Hadeer A Eassa; Dina Mohamed; Diana M Huynh; Abigail R Wiss; Jessica Sweeney; Monica T Oakes; Mark M Mikhail; Nadine Amine; Harshvir Kaur; Natalia Echeverry; Kamila Orzechowski; Doreen Szollosi

doi:10.1016/j.joim.2021.02.003

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

J Integr Med. 2021 May;19(3):232-242. doi: 10.1016/j.joim.2021.02.003. Epub 2021 Mar 2.

Authors

Mohamed Ismail Nounou¹, Heba A Eassa², Nada A Helal³, Khaled AboulFotouh⁴, Ihab Mansoor⁵, Isabel K Latz⁶, Cindy Zheng¹, Hadeer A Eassa⁷, Dina Mohamed⁸, Diana M Huynh¹, Abigail R Wiss¹, Jessica Sweeney¹, Monica T Oakes¹, Mark M Mikhail¹, Nadine Amine¹, Harshvir Kaur¹, Natalia Echeverry¹, Kamila Orzechowski¹, Doreen Szollosi¹

Affiliations

¹ Department of Pharmaceutical Sciences, School of Pharmacy & Physician Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford, Connecticut 06103, USA.
² Department of Pharmaceutical Sciences, School of Pharmacy & Physician Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford, Connecticut 06103, USA; Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, AL-Azhar University, Cairo 11651, Egypt. Electronic address: hebaabdullah@azhar.edu.eg.
³ Pharmaceutical Sciences Department, Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, Texas 77843, USA.
⁴ Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, Texas 78712, USA; Department of Pharmaceutics, Faculty of Pharmacy, Assiut University, Assiut 71526, Egypt.
⁵ Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria 21521, Egypt.
⁶ Department of Public Health Sciences, College of Health Sciences, The University of Texas at El Paso, TX 79968, USA.
⁷ Genetic Engineering and Biotechnology Research Institute, University of Sadat City, Sadat 32897, Egypt.
⁸ Department of Industrial Pharmacy, Faculty of Pharmacy, Alexandria University, Alexandria 21521, Egypt.

PMID: 33736960
DOI: 10.1016/j.joim.2021.02.003

Abstract

Objective: Nutraceutical products are widely used for their claimed therapeutic benefits. However, falsified or adulterated nutraceuticals present a major health threat to consumers. This study investigates the pharmaceutical quality, safety and anti-inflammatory effects of six male enhancement nutraceuticals that claim to be 100% natural.

Methods: Three batches of six male enhancement products were tested to detect the presence and levels of adulterants via high-performance liquid chromatography (HPLC). The pharmaceutical quality of the selected nutraceuticals was tested with near infrared spectroscopy (NIR) and SeDeM. The cytotoxic effects of these products on HepG2 cells were determined through cell proliferation (XTT) and lactate dehydrogenase (LDH) cytotoxicity assays. Lastly, the in vitro inflammatory effects of these products were investigated using murine J774 macrophages through cytokine release analysis.

Results: HPLC analysis detected the presence of sildenafil citrate, a vasodilator, and the active ingredient in Viagra and Revatio, in all batches of the products we analyzed. Amount of sildenafil citrate ranged from 0.45 mg to 51.85 mg among different batches. NIR assessment showed inter- and intra-batch heterogeneity in product composition. Results of the XTT and LDH assays showed significant cytotoxic effects of the analyzed products. XTT analysis revealed that the viability of HepG2 treated with tested products varied from 27.57% to 41.43%. Interestingly, the male enhancement products also showed anti-inflammatory effects.

Conclusion: Despite their labeling as 100% natural, all products tested in this study contained levels of sildenafil citrate, which was not reported on the packaging. There was a lack of pharmaceutical uniformity among products of the same batch and across different batches. Additionally, the products we tested had cytotoxic effects. These study findings highlight the adulteration, poor quality and hazard of these nutraceuticals. Therefore, strict regulation of these products and standardization of the definition of nutraceuticals are urgently needed. Further, these falsely advertised products should be withdrawn from the market due to potential adverse effects on the health of their consumers.

Keywords: Adulteration; Erectile dysfunction; Nutraceuticals; Online market; Sildenafil citrate.

MeSH terms

Animals
Dietary Supplements
Drug Contamination*
Male
Mice
Pharmaceutical Preparations*
Sildenafil Citrate

Substances

Pharmaceutical Preparations
Sildenafil Citrate