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

Figures & data

Table 1 Phosphodiesterase-5 (PDE5) Inhibitors Included in LC-MS Screen

PDE5 Inhibitor	Formula
Acetildenafil (hongdenafil)	C25H34N6O3
Aminotadalafil	C21H18N4O4
Dimethylsildenafil (aildenafil, methisosildenafil)	C23H32N6O4S
Gendenafil	C19H22N4O3
Homosildenafil	C23H32N6O4S
Hydroxyacetildenafil (hydroxyhongdenafil)	C25H34N6O4
Hydroxyhomosildenafil	C23H32N6O5S
Hydroxythiohomosildenafil (hydroxyhomosildenafil thione, sulfohydroxyhomosildenafil)	C23H32N6O4S2
N-Desethyl vardenafil	C21H28N6O4S
N-Desmethyl sildenafil	C21H28N6O4S
Norneosildenafil	C22H29N5O4S
Pseudovardenafil (piperadino vardenafil, piperidenafil)	C22H29N5O4S
Sildenafil	C22H30N6O4S
Tadalafil	C22H19N3O4
Thiodimethyl sildenafil (thioaildenafil, sulfoaildenafil)	C23H32N6O3S2
Thiohomosildenafil (homosildenafil thione, sulfohomosildenafil)	C23H32N6O3S2
Thiosildenafil (sildenafil thione, sulfosildenafil)	C22H30N6O3S2
Vardenafil	C23H32N6O4S
Xanthoanthrafil (benzamidenafil)	C19H23N3O6

Table 2 Number of Adulterants Detected in the 2016 – 2017 Survey of Products That Were Marketed as Dietary Supplements for Sexual Enhancement (n = 68)

	# of Samples	% of Adulterated Samples
Total	68	100%
>1 Drugs Detected	41	60%
1 Drug Detected	27	40%
2 Drugs Detected	33	49%
3 Drugs Detected	6	9%
4 Drugs Detected	2	3%

Figure 1 Number (and percent) of samples found to have each identified adulterant in the 2016 – 2017 survey of PDE5 inhibitor adulteration of products that were marketed as dietary supplements for sexual enhancement (n = 68).

Table 3 Adulterated Products Associated with a Previous FDA Warning in the 2016 – 2017 Survey of Products That Were Marketed as Dietary Supplements for Sexual Enhancement (n = 13)

Date(s) Product Was Purchased for FDLB Analysis^a	Made in USA?	Adulterants Detected by FDLB	No. of Adulterants Detected by FDLB	No. of FDA Warnings	FDA Warning Type(s)	FDA Warning Adulterants	Date of FDA Warning(s)	At least one common Adulterant Detected by both FDA and FDLB?
9/12/2016 and 11/22/2016	Yes	Tadalafil	1	1	Public Notification	Sildenafil	3/5/2015	No
9/12/2016 and 11/22/2016	Yes	Hydroxythiohomosildenafil; Sildenafil; Tadalafil; Thiosildenafil	4	2	Recall; Public Notification	Sildenafil; Sulfoaildenafil; Thioaildenafil	12/17/12 and 2/28/2015	Yes
9/13/2016 and 11/22/2016	Yes	Sildenafil; Tadalafil	2	1	Public Notification	Sildenafil	4/30/2015	Yes
9/13/2016	Yes	Sildenafil; Tadalafil; Thiodimethyl sildenafil	3	2	Recall	Desmethyl carbondenafil; Dapoxetine	10/9/2015 and 10/28/2015	No
11/1/2016 and 11/22/2016	Yes	Dimethylsildenafil; Thiodimethyl sildenafil	2	1	Recall	Aminotadalafil; Sulfohydroxyhomosildenafil	3/12/2013	No
11/1/2016 and 6/27/2017	Yes	Hydroxyhomosildenafil; Hydroxythiohomosildenafil; Sildenafil; Thiosildenafil	4	1	Recall	Sildenafil; Sulfoaildenafil; Thioaildenafil	12/17/2012	Yes
11/1/2016 and 11/22/2016	Yes	Sildenafil; Tadalafil	2	1	Recall	Dapoxetine; Desmethylcarbondenafil	11/16/2013	No
11/22/2016 and 12/5/2016	Yes	Sildenafil; Tadalafil	2	1	Recall	Sildenafil; Tadalafil; Desmethyl carbodenafil	9/20/2017	Yes
4/13/2017	Unknown	Sildenafil	1	3	Public Notification; Recalls	Sildenafil; Sulfoaildenafil	3/3/15 and 8/10/10 and 11/5/09	Yes
4/13/2017	Yes	Sildenafil; Tadalafil; Thiosildenafil	3	1	Public Notification	Sildenafil	6/22/2017	No
5/30/2017	Yes	Sildenafil	1	1	Public Notification	Sildenafil	12/22/2016	Yes
6/27/2017	Yes	Sildenafil	1	1	Recall	Desmethyl carbondenafil; Dapoxetine	10/9/2015	No
9/8/2017	Yes	Tadalafil	1	1	Public Notification	Sildenafil	3/5/2015	No

Notes: ^aSome products were purchased from different locations on different dates if one location did not have enough product to constitute a sample for analysis. When this was necessary, products with the same lot # and expiration date were purchased.

Figure 2 Number of products and estimated dose of detected PDE5 inhibitors with approved prescription dosage recommendations in the 2016 – 2017 survey of PDE5 inhibitor adulteration of products that were marketed as dietary supplements for sexual enhancement (n = 59). The prescription dose used for sildenafil is 25–100mg. The prescription dose used for tadalafil is 5–20mg.