Mini Review
Are Male Enhancement Ultraceuticals Sold Online Safe, Natural and Compliant with their Label Claim?
Nadine Amine, Cindy Zheng, Harshvir Kaur, Jessica Sweeney, Mark Mikail, and Mohamed Ismail Nounou*
Department of Pharmaceutical Sciences, University of Saint Joseph, USA
*Corresponding author: Mohamed Ismail Nounou, Department of
Pharmaceutical Sciences (DPS), School of Pharmacy and Physician
Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford,
CT, 06103, USA, Email:
nounou@usj.edu
Submitted: 30 May 2019; Accepted: 16 June 2019; Published: 18 June 2019
Cite this article: Amine N, Zheng C, Kaur H, Sweeney J, Mikail M, et al. (2019) Are
Male Enhancement Ultraceuticals Sold Online Safe, Natural and Compliant with their Label Claim? J Sexual Med Reprod Health 2: 7.
Attention to ultraceuticals has become extremely prevalent. A large surge of male enhancement ultraceuticals hashit the U.S. market
through online retail stores such as eBay, Amazon, GNC, and Alibaba that consist of unverified therapeutic label claims. The issue at hand
is the increase in the production, marketing and sale of adulterated products from these online retail stores that falsify the safety, efficacy,
and therapeutic claims on their websites. These products are further provoked to continue their false claims due to the absence of strict
regulatory laws to govern label claims, manufacturing, and marketing in U.S. and global markets. The online retail stores that sponsor
and advertise the sales of these ultraceuticals neglect the literature that show many of the products were discovered to be counterfeit,
mislabeled, or adulterated with active pharmaceutical ingredients (API). Ultimately, regulatory authorities should instill regulations in order
to monitor, examine, and test the ultraceutical market and the research community should draw public attention to the possible effects of
these products on consumers.
Keywords: Ultraceuticals; Adulteration; Counterfeit; Nutraceuticals; Male enhancement; Online retail stores
Natural, organic, chemical free, and homeopathic, are all
buzzwords consumers tend to associate with safety and efficacy.
In many cases, such marketing terminology is misleading
and deceitful [1]. Many people seek out this terminology
when purchasing dietary supplements and vitamins. Health
organizations and researchers have attempted to introduce
policies to regulate these industries and have largely failed due to
a lack of interest [2-5]. Ultraceutical formulations are expanding
widely to include products that include male-enhancement,
weight loss, and cognitive enhancement products. The U.S. Food
and Drug Administration (FDA) have very limited control over
dietary supplements. The FDA only regulates the labeling of these
products in the United States, requiring a disclaimer label stating
“This statement has not been evaluated by the FDA. This product
is not intended to prevent, cure or treat any disease” [6]. Despite
this, the advertised claims, trade names, and even the shape of
the pills suggest therapeutic effects as seen on their online retail stores.
Online sale of Ultraceuticals: a market place unchecked
The absence of regulatory laws, enforcement, and oversight
of the ultraceutical industry promotes the production and
adulteration of the products being sold; thus, encouraging
their trade throughout online retail stores including Alibaba,
GNC, eBay, and Amazon [7-10]. This is a major area of sales for
unregulated ultraceutical sales in the United States. In March
2019, over 10,000 and 10,938 male enhancement nutraceuticals
were advertised on Amazon and eBay, respectively [8,9]. Tables
1-4 list the top ten male enhancement ultraceuticals sold online
on Alibaba, GNC, eBay, and Amazon [7-10]. Comparing the four
markets, it is observed that the label on the products contains
the required FDA disclaimer label. However, in the title and
description of the products is where consumers will find many
unverified therapeutic claims. On Alibaba and eBay [7,9] (Tables
2,4) claims are aggressive, stating they are 100% safe, natural,
and of high quality with zero additives, as seen on the labels. Such
claims do not comply with the FDA labeling requirements for
dietary supplements [11]. In case of Alibaba and eBay [7,9] many
ingredients are not listed in the description and many omit the
ingredients label on the bottle. As for Amazon [8] (Table 1), most
products are claimed to be natural, however, the ingredients are
clearly shown in the product description. As for General Nutrition
Centers (GNC) (Table 3), ingredients and uses are clearly stated
in the description with clear ingredient labels and pictures of the
product. All these male enhancement ultraceuticals sold online
have therapeutic claims, such as boosting testosterone, increase
strength, or increase sexual health [10]. Table 1 Ten top-selling
products of male enhancement ultraceuticals on Amazon and
eBay retail online stores (February 2019).
Contents and Concerns
Ultraceuticals are not all safe, despite common misconception.
This can be attributed to their unnecessary use, unknown ingredients, and low pharmaceutical quality [1,12-16]. Some
products in the ultraceuticals category have been found to contain
pesticides, heavy metals, and adulterants [17-20]. Adulterated
products may contain incorrect parts of a plant or unreported
active pharmaceutical ingredients (APIs), as documented in
previous cases [12,17-20]. Herbal adulteration has also been a
problem. A recent study found male enhancement supplements
contained at least 1 of 5 unreported plants of concern [21]. Other
cases of adulteration of male-enhancement nutraceuticals with
sildenafil, vardenafil, or tadalafil have been previously reported
[12]. Fraudulent adulteration may increase the therapeutic effect
but is illegal, unethical, and can cause significant harm. Following
consumption of the male enhancement supplement Rhino 7
Platinum 3000, a 25-year-old man required bilateral corpoglanular
shunting to alleviate his priapism that had persisted for
48 hours; A follow up appointment demonstrated he is no longer
able to maintain an erection and has significant bilateral fibrosis
of the corporal bodies [22].
The purpose of the undocumented APIs spiking and
adulteration is for manufacturers to increase the therapeutic
effects of their products; simultaneously claiming them to be
of natural origin in order to market their products in a more
favorable, pleasing psychological influence to consumers [17-
20]. Consumers are unaware of the true ingredients within these
naturally claimed products, which make them susceptible to
drug-drug interactions that can cause a great risk to their health
and safety. It can ultimately cause permanent damage as seen in
the case of Rhino 7 Platinum 3000 [22].
Many of the male enhancement ultraceuticals sold online were
found to be adulterated with reported or unreported analogues
of FDA-approved prescription phosphodiesterase-5 inhibitors
(PDE5i) used to treat erectile dysfunction such as sildenafil,
tadalafil, or vardenafil [1,11,12,15,16]. A study conducted by Pfizer Global Security and Research and Development teams
found 81% of sexual performance ultraceuticals contained
adulterated PDE5is, 45% of those contained more than the
highest approved strength of the drug [23]. Novel PDE5i
analogues such as desmethylpieprazinyl propoxysildenafil
continue to be discovered in this class of dietary supplements
[24]. The presence and quantity of these adulterants is of great
concern due to the known risks associated with this class of FDA
approved drugs and the uncertainty of the safety of the untested
PDE5i analogues. ZenMaxx, Instant Hard Rod, and RigiRx Plus
were all found to contain amino-tadalal, an analog of tadalafil [25].
This interacts with nitrates found in some prescription drugs and
may dangerously lower blood pressure [5,26,27]. These products
pose a threat to patients with diabetes, high blood pressure, high
cholesterol, or heart disease [28]. Many of the products described
above can be seen on the FDA list of tainted products marketed
as dietary supplements though, based on a survey of current
literature, however, it is by no means a comprehensive list [11].
Action required
Nutraceuticals and ultraceuticals are advertised as purely
natural products free from side effects. They are widely sold
online via major retail stores such as Amazon, eBay, and Alibaba
from unknown sources from all over the world, mostly with a
therapeutic claim that violates FDA and DSHEA guidelines [6-
9]. Literature review shows that these products are adulterated,
misbranded, mislabeled, are of low pharmaceutical quality, and
may be dangerous because of the presence of undeclared plant
products and APIs. These products often contain disingenuous
review from which consumers base their decision making [29].
Health organizations and governments are aware of the illegal
manufacture and sale of adulterated and counterfeit nutraceutical
formulations, yet no laws or regulations are enforced to tackle
this global problem [30].
Conclusions and Future Directions
There are expanding issues around adulterated and
counterfeit nutraceuticals globally. There seems to be gray areas
in the U.S. market where these nutraceuticals are being sold
regarding their claim, safety, efficacy, registration, sales, and
regulation.
Male enhancement nutraceuticals which are sold freely
online should be researched, analyzed, and evaluated with
respect to claim, content, safety, and efficacy. Researchers should
be encouraged to investigate the quality, safety, and efficacy
of supplements suspected to have illegal therapeutic claims.
Technologies should be utilized for the fast and accurate detection
of adulterants and counterfeit products. These technologies
include near infra-red (NIR) spectrophotometry or simple
spectrophotometric analysis [1,31,32]. This problem has led to
the development of innovative detection technologies including
portable drug identification devices such as Si-Ware systems
fully integrated chip-sized spectral sensor (NeoSpectra™ sensors)
and Stratio LinkSquare pen spectrophotomer for industrial and
consumer markets [31,32]. NeoSpectra™ sensors are compact
and low-cost Fourier Transform near InfraRed (FT-NIR) spectral
sensors that can provide portable, fast and accurate analyses
for medical and pharmaceutical application. Such systems can
be used for the fast and accurate detection of adulterants and
counterfeit products in the pharmaceutical industry sector,
insurance agencies, law enforcement agencies, airports and retail
pharmacies along with consumers [32]. They deliver the spectral
response of the light absorbed by materials for quantification,
qualification or identification [32]. Moreover, the development
of rapid and accurate analytical techniques is critical. A new
assay has been developed to rapidly detect PDE5 inhibitors using
fluorescence that can even successfully uncover new analogues
in low concentrations [33]. Ultraceuticals research is critical
for online marketplace warehouses, regulatory agencies, and
consumers with respect to safety, efficacy and quality.
Ultimately, this problem is the result of a rapidly growing
industry going unchecked. Global and national health
organizations should implement new regulations or enforce
existing regulations for nutraceuticals to protect consumers and
hold those who profit from their manufacture, distribution, and
sale accountable for adverse effects.