Are Male Enhancement Ultraceuticals Sold Online Safe, Natural and Compliant with their Label Claim? - JSM Central
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Journal of Sexual Medicine and Reproductive Health
Mini Review © Amineet N, et al. 2019
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
Abstract
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
Introduction & Background Problem Online sale of Ultraceuticals: a market place
unchecked
Natural, organic, chemical free, and homeopathic, are all
buzzwords consumers tend to associate with safety and efficacy. The absence of regulatory laws, enforcement, and oversight
In many cases, such marketing terminology is misleading of the ultraceutical industry promotes the production and
and deceitful [1]. Many people seek out this terminology adulteration of the products being sold; thus, encouraging
when purchasing dietary supplements and vitamins. Health their trade throughout online retail stores including Alibaba,
GNC, eBay, and Amazon [7-10]. This is a major area of sales for
organizations and researchers have attempted to introduce
unregulated ultraceutical sales in the United States. In March
policies to regulate these industries and have largely failed due to
2019, over 10,000 and 10,938 male enhancement nutraceuticals
a lack of interest [2-5]. Ultraceutical formulations are expanding were advertised on Amazon and eBay, respectively [8,9]. Tables
widely to include products that include male-enhancement, 1-4 list the top ten male enhancement ultraceuticals sold online
weight loss, and cognitive enhancement products. The U.S. Food on Alibaba, GNC, eBay, and Amazon [7-10]. Comparing the four
and Drug Administration (FDA) have very limited control over markets, it is observed that the label on the products contains
dietary supplements. The FDA only regulates the labeling of these the required FDA disclaimer label. However, in the title and
products in the United States, requiring a disclaimer label stating description of the products is where consumers will find many
“This statement has not been evaluated by the FDA. This product unverified therapeutic claims. On Alibaba and eBay [7,9] (Tables
is not intended to prevent, cure or treat any disease” [6]. Despite 2,4) claims are aggressive, stating they are 100% safe, natural,
this, the advertised claims, trade names, and even the shape of and of high quality with zero additives, as seen on the labels. Such
claims do not comply with the FDA labeling requirements for
the pills suggest therapeutic effects as seen on their online retail
dietary supplements [11]. In case of Alibaba and eBay [7,9] many
stores.
ingredients are not listed in the description and many omit the
ingredients label on the bottle. As for Amazon [8] (Table 1), most
Submitted: 30 May 2019 | Accepted: 16 June 2019 | Published: 18 June products are claimed to be natural, however, the ingredients are
2019 clearly shown in the product description. As for General Nutrition
Centers (GNC) (Table 3), ingredients and uses are clearly stated
*Corresponding author: Mohamed Ismail Nounou, Department of
Pharmaceutical Sciences (DPS), School of Pharmacy and Physician in the description with clear ingredient labels and pictures of the
Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford, product. All these male enhancement ultraceuticals sold online
CT, 06103, USA, Email: nounou@usj.edu have therapeutic claims, such as boosting testosterone, increase
Copyright: © 2019 Amineet N, et al. This is an open-access article
strength, or increase sexual health [10]. Table 1 Ten top-selling
distributed under the terms of the Creative Commons Attribution products of male enhancement ultraceuticals on Amazon and
License, which permits unrestricted use, distribution, and reproduction in eBay retail online stores (February 2019).
any medium, provided the original author and source are credited.
Contents and Concerns
Citation: Amine N, Zheng C, Kaur H, Sweeney J, Mikail M, et al. (2019) Are
Male Enhancement Ultraceuticals Sold Online Safe, Natural and Compliant Ultraceuticals are not all safe, despite common misconception.
with their Label Claim? J Sexual Med Reprod Health 2: 7. This can be attributed to their unnecessary use, unknown
J Sexual Med Reprod Health 2: 7 1/7
Table 1: Ten top-selling products of male enhancement ultraceuticals on Amazon retail online store in the United States (February 2019)
[8].
Product Brand Name Ingredients Claim
Tongkat Ali Extract, saw palmetto extract,
• Optimizes physical performance
Prime Labs Men’s orchic substance wild yam extract, sarsaparilla,
• Stronger and leaner muscles
1 Testosterone nettle extract, boron, magnesium stearate,
• Improves mood
Booster silicon dioxide, hydroxypropyl methylcellulose,
• Healthy natural formula
microcrystalline cellulose, stearic acid
• Boost sexual performance level
Icariin, arginine HCl, royal jelly, ginseng, black • Increase pumps and fullness
2 Leyzene pepper extract, gluconolactone, magnesium • More vascularity
sterate, and gelatin Capsule • Maximize sexual performance time
• Surge endurance levels
• Natural supplement for men and women
Horny Coat Weed Horny Goat Weed extract, maca root, tongkat
3 • Infused with pure potent enhancers
Herbal Complex Ali, ginseng, L-Arginine
• Promotes healthy blood circulation
4 • Natural boost
Organic Maca Root, Black Pepper Extract,
Organic Maca Root • Increases passion and performance
Vegetable Cellulose Capsule
• Superior absorbance and benefits
Macuna Pruriens (L-Dopa), Polypodium
• Sexual organs size increase
5 AlphaMan XL Vulgare, Yohimbe Bark, Saw Palmetto, Muira
• Increasing stamina
Puama, L-Arginine & Panax Ginseng
zinc, maca root, horny goat weed, ginseng, • Improved sex drive
6 Golden X Tribulus terrestris and pomegranate, • Energy and stamina boost
Schisandra Berry • No side effects
7 BigRize boosts testosterone, fast and long acting • Highest quality herbal supplement
boostULTIMATE • Boost sexual performance
8 Testosterone Ginseng, Muira Puma, and Maca, L-arginine • Testosterone boosters help with building men's drive and
Booster Pills enhancing endurance
Tribulus Terrestris Extract, Horny Goat Weed,
Boost Elite Test Fenugreek Extract, Maca Root, Zinc Citrate,
9 • Boosts sexual passion
Booster DIM, Panax Ginseng, Tongkat Ali Extract, &
Yohimbe Bark Extract
Nitric oxide, arginine Alpha-Ketoglutarate,
High T Black • Powerful libido
citrulline-malate, beta alanine, caffeine
Natural • Workout enhancing properties
10 anhydrous, eurycoma longifolia, raspberry
Testosterone • Helps bring back youthful energy and performance in and
ketone, rhodiola rosea, and testofen fenugreek
Booster out of the bedroom with long term use
extract.
Table 2: Ten top-selling products of male enhancement ultraceuticals on eBay online store in the United States (February 2019) [9].
Product Brand Name Ingredients Claim
Kangaroo Male • Premium blend scientifically designed for men to increase sexual pleasure
1 Sexual Performance Not reported and performance.
Enhancement • Formulated to promote longer harder erections and enhance sexual activity.
Tribulus, cordyceps militaris,
• Not counterfeit
Poseidon Platinum ginger root, cnidimum, monnier
2 • Longer and harder erection
3500 extract, theobromine, rhodioia,
• Increase in time, size, and stamina
and avena sativa extract
• Maximize the time of intercourse
• Help ease premature ejaculation
• Increase size
3 Zeus 1600 Not reported
• More stamina
• No headache
• Fast acting
72-hour natural male enhancement pill that takes the worry out of what
4 REV72 Ginkgo biloba, testosterone
you’re putting in your body
• Maximize the time of intercourse
• Help ease premature ejaculation
5 Dragon 69 12000 Not reported • Better ejaculation control.
• Maximize in length, width, and stamina
• All natural and no chemicals
J Sexual Med Reprod Health 2: 7 2/7
• Contains zero fillers, binders, and artificial ingredients
Tongkat ali, ginseng root
Natural Life • Testosterone booster
6 extract, tribulus extract, gotu
Magnum Size • 100% natural herbal product that doesn’t require a medical prescription, as
kola, and ginkgo biloba.
it is not an ED treatment
Avena sativa, catubaba bark
powder, L-arginine HCl, maca
powder, muira pumama herb
• 100% natural
powder, sarsaparilla, tribulus
7 Fullitor • Made in the USA,
terresteris extract, siberian
• #1 best male enhancement pill that helps enhance sex
ginseng, pumpkin seed, horny
goat weed, icarin, magnesium
stearate, and silicon dioxide
Tribulus extrat, tongkat ali • 100% natural and safe
extract, ginseng, centellia • No fillers, binders, orartificial ingredients
Best Herb
8 asiatica gotu kola, gingko • Increases sexual stamina
Big Girth
bilbao, butea superba, and • Bigger and harder erections
reishi • Boost sexual power and libido
Maca root powder, tribulus
terrestris, polypodium vulgare
• Extreme pharmaceutical grade male formula with extreme strength
powder, muira puama root
9 Extensions IV • All-natural ingredients with scientifically proven and permanent results of
powder, L-arginine, panax
increasing size by 4-6 inches
ginseng root powder, hhorny
goat weed extract, and incarins
• Authentic product
Dignity Bio Labs
10 Not reported • Natural male enhancement
Viril X
• Increases size, stamina, and strength
Table 3: Ten top-selling products of male enhancement ultraceuticals on General Nutrition Centers (GNC) online and retail stores in the United States
(February 2019) [10].
Product Brand Name Ingredients Claim
• Boosts free testosterone
D-Aspartic acid, fenugreek extract, epimedium
Nugenix Ultimate • Maximize muscle and strength
1 sagittatum, stinging nettle, maca, mucuna pruriens
Testosterone • Increase drive and vitality
extract, eurycoma longifolia extract, and boron
• Modulate androgenic activity
GNC Men’s MACA Niacin, niacinamide, L-Arginine, lepidium meyenii, • Advance sexual health
2
Man pausinystalia yohimba, ginkgo biloba leaf extract • Fuels nitric oxide production for enhanced blood flow
L-Citrulline malate, fenugreek extract, ancient peat • Increase lean muscle mass
Nugenix
3 extract, apple fruit extract, eurycoma longifolia extract, • Boost free and total testosterone
Total-T
boron glycinate • Support stronger sex drive
Retinyl palmitate, ascorbic acid, thiamin
mononitrate, riboflavin, niacinamide, folic acid,
4 • Advanced sexual health formula
GNC Men’s cyanocobalamin, biotin, calcium d-Pantothenate,
• Helps support sexual desire
Arginmax zinc gluconate, selenium selenate, pyridoxine HCI,
• Improves sexual performance and power
L-Arginine, aerial part and root, American ginseng, and
ginkgo biloba leaf extract
Cholecalciferol, zinc l-monomethionine, fenugreek
extract, ashwagandha extract, shailajit purified extract,
• Boost free testosterone
tribulus alatus extract, eurycoma longifolia extract,
5 Nugenix MAXX • Support libido and energy
rhodiola extract, maca extract, panax ginseng extract,
• Increase muscle strength
white button mushroom extract, and black pepper
extract.
L-Citrulline Malate, Fenugreek Extract (seed),
• Increase lean muscle mass
Nugenix® elevATP® Blend (Ancient Peat Extract (trace minerals)
6 • Boost free & total testosterone
Total-T and Apple Fruit Extract), Eurycoma longifolia Extract
• Support stronger sex drive
(root), Boron
J Sexual Med Reprod Health 2: 7 3/7
Zinc, magnesium glycinate, fenugreek seed extract,
ashwagandha extract, tribulus terrestris extract,
chrysin, sage leaf extract, bovine colostrum, calcium
GNCAMP hydroxymethyl butyrate monohydrate, Indole- • Supports testosterone & libido
7
Test 1700 3-carbinol, tongkat ali root extract, rhaponticum • Fuels muscle performance
carthamoides root extract, DIM, maitake mushroom
mycelia powder, shiitake mushroom mycelia powder,
reishi mushroom powder, velvet elk antler powder
L-Arginine, kola nut powder, oat straw stems powder,
• Has key nutrients and exotic herbs to enhance male
GNC Men’s gamma-amino butyric acid, nettle leaf powder, yohimbe
sexual performance
8 Staminol bark extract, horny goat weed powder, muira puama
• Supports normal prostate function and healthy urinary
root powder, damiana leaf powder, and saw palmetto
flow
berries powder
Vitamin D, Vitamin K2, Magnesium, ashwagandha • Testosterone booster, premium drive & vitality
Alpha King
9 extract, fenugreek seed liposomal extract, macuna • Compelling muscle & strength
Supreme Elite
pruriens, DIM, boron, and L-citrulline. • Mind-blowing sexual performance
Vitamin E, riboflavin, folate, selenium, thiamin, niacin,
vitamin B-12, zinc, L-arginine, Testofen® Fenugreek • A powerful combination of ingredients, including
Men’s Seed Extract, MegaNatural® -BP™ Grape Seed Extract, L-arginine for intense vasodilation
10
StaminolTM Ultra maca powder, Asian ginseng root extract, Yohimbe • A potent blend of herbs designed to support sexual
bark extract, Horny Goat Weed extract, Hawthorn berry health and vitality
extract, Ginkgo biloba leaf extract
ingredients, and low pharmaceutical quality [1,12-16]. Some Pfizer Global Security and Research and Development teams
products in the ultraceuticals category have been found to contain found 81% of sexual performance ultraceuticals contained
pesticides, heavy metals, and adulterants [17-20]. Adulterated adulterated PDE5is, 45% of those contained more than the
products may contain incorrect parts of a plant or unreported highest approved strength of the drug [23]. Novel PDE5i
active pharmaceutical ingredients (APIs), as documented in analogues such as desmethylpieprazinyl propoxysildenafil
previous cases [12,17-20]. Herbal adulteration has also been a continue to be discovered in this class of dietary supplements
problem. A recent study found male enhancement supplements [24]. The presence and quantity of these adulterants is of great
contained at least 1 of 5 unreported plants of concern [21]. Other concern due to the known risks associated with this class of FDA
cases of adulteration of male-enhancement nutraceuticals with approved drugs and the uncertainty of the safety of the untested
sildenafil, vardenafil, or tadalafil have been previously reported PDE5i analogues. ZenMaxx, Instant Hard Rod, and RigiRx Plus
[12]. Fraudulent adulteration may increase the therapeutic effect were all found to contain amino-tadalal, an analog of tadalafil [25].
but is illegal, unethical, and can cause significant harm. Following This interacts with nitrates found in some prescription drugs and
consumption of the male enhancement supplement Rhino 7 may dangerously lower blood pressure [5,26,27]. These products
Platinum 3000, a 25-year-old man required bilateral corpo- pose a threat to patients with diabetes, high blood pressure, high
glanular shunting to alleviate his priapism that had persisted for cholesterol, or heart disease [28]. Many of the products described
48 hours; A follow up appointment demonstrated he is no longer above can be seen on the FDA list of tainted products marketed
able to maintain an erection and has significant bilateral fibrosis as dietary supplements though, based on a survey of current
of the corporal bodies [22]. literature, however, it is by no means a comprehensive list [11].
The purpose of the undocumented APIs spiking and Action required
adulteration is for manufacturers to increase the therapeutic
effects of their products; simultaneously claiming them to be Nutraceuticals and ultraceuticals are advertised as purely
of natural origin in order to market their products in a more natural products free from side effects. They are widely sold
favorable, pleasing psychological influence to consumers [17- online via major retail stores such as Amazon, eBay, and Alibaba
20]. Consumers are unaware of the true ingredients within these from unknown sources from all over the world, mostly with a
naturally claimed products, which make them susceptible to therapeutic claim that violates FDA and DSHEA guidelines [6-
drug-drug interactions that can cause a great risk to their health 9]. Literature review shows that these products are adulterated,
and safety. It can ultimately cause permanent damage as seen in misbranded, mislabeled, are of low pharmaceutical quality, and
the case of Rhino 7 Platinum 3000 [22]. may be dangerous because of the presence of undeclared plant
products and APIs. These products often contain disingenuous
Many of the male enhancement ultraceuticals sold online were review from which consumers base their decision making [29].
found to be adulterated with reported or unreported analogues Health organizations and governments are aware of the illegal
of FDA-approved prescription phosphodiesterase-5 inhibitors manufacture and sale of adulterated and counterfeit nutraceutical
(PDE5i) used to treat erectile dysfunction such as sildenafil, formulations, yet no laws or regulations are enforced to tackle
tadalafil, or vardenafil [1,11,12,15,16]. A study conducted by this global problem [30].
J Sexual Med Reprod Health 2: 7 4/7
Table 4: Ten top-selling products of male enhancement ultraceuticals on the global Alibabaonline store (February 2019) [7].
Product Brand Name Ingredients Claim
• 100% new high quality
• All natural, experience
• Hard erection
• Increase ejaculation
1 Marfly MACA Peruvian natural maca plant • Increase length, width and endurance
• Increase sexual confidence
• Increase orgasm
• Prevent premature ejaculation
• No prescription required
• 100% safe, zero additives, and zero side effects
Maca Root 50%, 100%, Aguaje powder,
• The most effective penis enlargement pill currently available
pueraiMirifica, Mexican wild Yam, Saw palmetto,
2 Sheng FO • It combines all the most potent all-natural herbal ingredients
Dong Quai Root, Dandelion Root, Fenugreek seed,
scientifically dosed to enhance penis fullness, size, and sexual
and Vegetarian Capsules
satisfaction
• 100% pure and natural
• Promotes penis growth
Alpha Male • Gain harder and longer erections
3 100% herbal extract complex
Enhancement • Increasing sperm and testosterone levels
• Improves libido.
• No fillers, binders, or additives
Okra Oyster • Increases sexuality
4 Abelmoschus esculentus moench, and maca
Tablet • Natural supplements with strong erections
• Natural supplements prolonging erections for men
Yohimbe
5 Yohimbe Bark Extract • Androgen promoting testosterone that dilates local blood
Bark
vessels and allow blood to circulate
Safed Musli, Shilajit, Mucuna Pruriens,
• Booster herbal extract supplement
Vitality Ashwagandha, Akarakarabha, Kokilaksha,
• 100% vegetarian
6 Vigour Parasika Yavani, Jatiphala, Lavanga, Tvak,
• Helps boost libido levels
Capsules Makaradwaja, Vanga Bhasma, Abhrak Bhasma,
• Enhance sexual capacity in both men and women
Kukkutanda Bhasma.
Epimedium, Condonopsis Pilosula, Eucommia
Ulmoides, Rubus Parvifolius, Fructus Lycii,
Angelica Sinensis, Schisardra Chinensis, Herba
Cistanche, Rehmanna Glutinosa, Cinnamomum
• Traditional Chinese herbal supplement
Cassia, Achyranthes Bidentata Blume, Semen
• 100% herbal ingredients
7 MaBido Biotae Orientalis, Dioscorea Opposita, Zizyphus
• Improves health
Jujube Larn, Atractylodes Macrosephala, Rosal
• Boosts libido
Laevigata, Cornus Officinalis, Radix Paeoniae
Alba, Sstragalus Membranaceus, Radix Polygoni
Multiflora, Gingko Biboba, Poria cocos,
Goycyrhiza Glabra, Radix Polygalae.
Nutriceleb-
L-arginine, tribulus terrestris, lepidium meyenii, Advanced formula that promotes sexual health including desire,
8 rity Ultra
and epimedium graniflorum. performance and stamina
Tribido
• 100% Indian herbal and pure Ayurveda formulation
Shilajit Withania somnifera, chlorophytum
• Improvevigor and vitality
9 Herbal arundinaceum, curculigo orchioides, asphaltum
• Potent and world known rejuvenator
Capsule purified, swaranmakshik bhasma.
• No preservatives, excipients, or additives used
Withania somnifera, chlorophytum borivilianum,
asparagus racemosus, mucuna pruriens, • 100% pure
Vitomanhills
10 ipomea digitata, hygrophilia spinosa, myristica • Increases sperm count& men’s health
Men’s Health
fragrans, phaseolus mungo, asphaltum, anacyclus • Promote sexual health, fertility, and sexual performance
pyrethrum, and cow milk.
J Sexual Med Reprod Health 2: 7 5/7
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