Cross-Sectional Survey of Adulterated Sexual Enhancement Products Sold in the Sacramento Area of California

Abstract

Purpose

The Food and Drug Administration (FDA) has warned against tainted products for sexual enhancement containing prescription phosphodiesterase-5 (PDE5) inhibitors marketed as dietary supplements. The California Department of Public Health (CDPH)’s Food and Drug Branch (FDB) initiated a study to assess the presence of such adulterated products, specifically to identify the presence of PDE5 inhibitors in dietary supplements marketed for sexual enhancement, sampled at local retail locations.

Methods

A convenience sample of products marketed as sexual enhancement dietary supplements was purchased from retail stores, within a 15-mile radius of downtown Sacramento, California. Samples were submitted to the Food and Drug Laboratory Branch (FDLB) and screened for 19 different PDE5 inhibitors using liquid chromatography-mass spectrometry. Samples were collected and analyzed from 2016 to 2018.

Results

One hundred and two different products were purchased from 28 different retail locations. Sixty-seven percent were found to be adulterated with at least one PDE5 inhibitor. Of the positive samples, 40% were found to contain one PDE5 inhibitor and 60% were found to contain two or more. Sildenafil was the most common PDE5 inhibitor identified (74%), followed by tadalafil (59%). Eighteen percent of the tested samples had been associated with previous FDA warnings listed in their Tainted Products Database. Of these warning-associated samples, 72% were found to contain PDE5 inhibitors and 46% of these contained at least one of the same adulterants reported by the FDA.

Conclusion

FDA reports and warnings have focused on dietary supplements found online or through screenings of international mail shipments. FDB results add to FDA findings by demonstrating that such adulterated products marketed for sexual enhancement are also sold at retail locations in California. These products have the potential to cause severe adverse health effects and therefore, it is essential to raise awareness of this significant public health concern.

Keywords:

• dietary supplements
• sexual enhancement products
• adulteration

Acknowledgments

This study was completed as part of a California Epidemiologic Investigation Service (Cal-EIS) Fellowship placement with FDB’s Science and Education Section. We would like to thank the Cal-EIS program staff for their assistance and support throughout the fellowship as well as the Preventive Health Services Block Grant from the Centers for Disease Control and Prevention, which supported this project. We would like to show our sincere appreciation to Steven Woods (former Chief, Division of Food, Drug and Radiation Safety), Dr. David Mazzera (former FDB Branch Chief and current Division Chief, Division of Food and Drug Safety), Dr. Bahman Moezzi (FDLB Branch Chief), and FDB management, Benson Yee and Dr. Carrie Ferstl, for providing their support and resources for conducting this study. We would also like to thank former FDB summer interns Vikas Gill and Ericka McNeal for their help with the initial dietary supplement survey.

Disclosure

The authors report no conflicts of interest in this work.