According to the National Institute
for Aging, quackery is at an all-time high.1 American consumers are
exposed to an overwhelming sea of advertising for dietary supplements and
homeopathic products. Many consumers assume that some government entity, such
as the FDA, has ruled these products safe and effective before allowing the
ads to be broadcast and printed. Many people do not realize, however, that the
products are not proven safe for use. This widespread misconception has
resulted in the spending of hundreds of millions of dollars for products whose
efficacy has not been validated by clinical trials. In effect, many consumers
are placing their trust in products promoted by manufacturers who do not
invest the funds to carry out research to prove the safety and efficacy of
Patent Medicines and Dietary
to enhance sexual performance have been promoted for over a century, dating
back to the patent medicines of the 1800s; these products were characterized
by wildly exaggerated claims and sold to the public by unscrupulous
manufacturers, without evidence of safety or effectiveness. The 1906 Pure Food
and Drug Law was an attempt to eliminate this pernicious practice, and for
many years Americans were somewhat better protected from unproven products.
2 However, the passage of the 1994 Dietary Supplement Health and
Education Act, championed by Utah's Orrin Hatch, allowed manufacturers to
market products without FDA approval of safety and efficacy.2
the male's serum testosterone levels fall, leading in many cases to erectile
dysfunction.3 Males cannot achieve an erection or cannot sustain
one for a sufficient time to complete sexual intercourse. The penis may
gradually disengorge during intercourse. Legitimate medical interventions
include testosterone, Viagra, Caverject, and devices inserted into the penis.
Patients undergoing andropause often
do not choose these
therapies, opting instead to try dietary supplements. As millions of baby
boomers are currently experiencing andropause, marketers offer hundreds of
products allegedly beneficial in reversing impotence and enhancing male sexual
The FTC and Impotence Claims
The Federal Trade
Commission (FTC) is a government agency charged with preventing fraudulent,
deceptive, and unfair business practices and with helping educate consumers to
avoid them.5 The FTC issued a consumer alert entitled The Truth
About Impotence Claims. The agency clarified several issues and disspelled
a great deal of manufacturer hype:
• Products advertised as effective
for treating impotence without a physician's prescription should be ignored,
as they cannot cure the condition.
advertised as "breakthroughs" in the treatment of impotence mandate double
checking with a physician for legitimacy.
manufacturers create phony "clinics" and fake "institutes" solely to promote
bogus impotence cures. Consumers should check with a physician to verify the
legitimacy of these organizations.
manufacturers of impotence cures claim that their product is "scientifically
proven" to work. When a consumer sees the phrase "clinical studies prove it
works," caution is in order, as these claims are often false. Furthermore,
claims providing very high rates of success are often bogus.
• When impotence
cures are said to be "herbal" or "all natural," the product should be ignored.
There is no herb or "all natural" substance proven to cure impotence.
The agency also urges consumers to
consult a qualified practitioner for treatment of impotence, rather than
placing one's trust in their bogus remedies.
The FDA's 2006 Announcement
In the fight
against fake impotence and sexual enhancement products, the FDA revealed in
2006 that it had completed a groundbreaking survey in which it analyzed 17
"dietary supplements" promoted on the Internet for erectile dysfunction or
enhancement of sexual performance.6 The FDA explained that some of
these products (Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Acta-Rx, and
4EVERON) were promoted and sold as dietary supplements but were actually
illegal drugs containing potentially harmful, undeclared ingredients, such as
sildenafil or analogues of sildenafil or vardenafil. The agency concluded that
the claims made for these products were claims made for the undeclared
nondietary supplement components, making them illegal drugs. The FDA sent
warning letters to the marketers explaining the illegal nature of their
activities, halted shipment of some of them into the United States, and
threatened to take additional actions.
The FDA's Final Rule
In June 2007, the
FDA announced a final rule establishing regulations for the current good
manufacturing practices (CGMP) of dietary supplements, partly due to the 2006
study of sexual enhancement/impotence products.7-11 Henceforth, the
FDA's new CGMPs will ensure that supplements are produced in a quality manner,
do not contain contaminants or impurities, and are accurately labeled. The
rule is effective as of August 24, 2007, for large businesses and somewhat
later for small businesses. Watchdog groups immediately pointed out that
supplement manufacturers have never been required to prove their products are
safe and effective, and the new regulations also fail to require this
fundamental evidence of quality.12 An expert quoted by ABC News
stated, "Knowing you have pure and well-made useless crap is a little better
than having impure useless crap, but not by much."13
What About Bob? The Enzyte
marketers are in steep competition to capture a share of this lucrative
business, one has managed to rise above the others, with its ubiquitous
"Smiling Bob" Enzyte ads. This marketer has capitalized on the current
thinking that an unproven dietary supplement can easily cure or treat a
serious medical condition such as impotence. Early ads promised that Enzyte
would add as much as three inches to the length of the user's penis.14
Web site testimonials also claim such benefits as allowing stronger, firmer,
and easier-to-achieve erections, assisting in maintaining a fully hard
erection, providing full and satisfying erections, and reversing the normal
erectile problems of aging.15-19 Enzyte contains many ingredients,
none of which is FDA-proven to be safe or effective in accomplishing its
advertised purposes. These ingredients include niacin, zinc, copper, Korean
red ginseng root, ginkgo, pine bark, Tribulus terrestris, arginine,
Avena sativa, horny goat weed, maca root, muira puama, saw palmetto, and
Swedish flower pollen.20,21
The Cincinnati-based marketer of
Enzyte, Berkeley Nutraceuticals, was reported in 2004 by a Cincinnati
newspaper to be the subject of over 3,700 consumer complaints.22 In
early 2006, Berkeley and its subsidiaries reached a settlement with the
attorneys general of 18 states and Washington, D.C. in which it would pay $2.5
million and provide restitution to customers for unsubstantiated claims about
the efficacy of their products.23-25 The $2.5 million settlement
was a burden easily borne by the company, as it may have reaped as much as a
quarter of a billion dollars in 2004 alone through sales of Enzyte and 14
other unproven supplements.26 Later in 2006, the U.S. Department of
Justice indicted the company and six individuals (including the president and
owner) for bilking Americans of at least $100 million.27 Fraudulent
business practices included sending consumers supplements they did not order,
charging their credit cards without authorization, laundering the money, and
mislabeling a product known as Rovicid. Despite the indictments and
settlements, the company continues to advertise and sell its products to a
public seemingly unaware of the controversy.
Quality of Research on Dietary
When research on
dietary supplements intended for sexual enhancement appears, it must be
scrutinized closely to assess the soundness of the methodology employed. Two
such studies explored the abilities of KyoGreen powder (barley, wheat grass,
seaweed) for sexual dysfunction in men and women and ArginMax (herbs,
vitamins, minerals) to enhance sexual function in males.28,29 While
both studies seemed to show positive results, they are rendered virtually
useless because neither study used a control group that was administered a
placebo for a valid comparison. Unfortunately, much of the research on dietary
supplements is hampered by profound flaws such as this that would cause the
research to be rejected by the FDA if it were to be submitted through the
legitimate new drug application process used for new medications.
What Should the Pharmacist Do?
Lack of evidence
about the safety and efficacy of dietary supplements exposes the consumer to
unknown health hazards, as these products use ingredients that are of unknown
therapeutic benefit. Marketers of these supplements have been known to engage
in fraudulent and deceptive practices. Marketing hype and high profits should
never override the pharmacist's professional responsibility to demand proof of
safety and efficacy in the products we recommend. Patients experiencing
andropause deserve a pharmacist who will refer them for legitimate medical
care rather than selling them products that lack proof of efficacy and safety.
1. Health quackery: Spotting health scams. National Institute on Aging.
Available at: www.niapublications.org/agepages/healthqy.asp. Accessed June 29,
2. Pray WS. A History of Nonprescription Product Regulation. New York,
NY: The Haworth Press, Inc.; 2003.
3. Hafez B, Hafez ES. Andropause: endocrinology, erectile dysfunction, and
prostate pathophysiology. Arch Androl. 2004;50:45-68.
4. Broeder CE. Oral andro-related prohormone supplementation: do the potential
risks outweigh the benefits? Can J Appl Physiol. 2003;28:102-116.
5. FTC Consumer Alert. The truth about impotence treatment claims. Federal
Trade Commission. Available at:
www.ftc.gov/bcp/conline/pubs/alerts/impoalrt.htm. Accessed June 29, 2007.
6. FDA warns consumers about dangerous ingredients in "dietary supplements"
promoted for sexual enhancement. Food and Drug Administration. Available at:
www.fda.gov/bbs/topics/NEWS/2006/NEW01409.html. Accessed June 29, 2007.
7. FDA issues dietary supplements final rule. Food and Drug Administration.
Available at: www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html. Accessed June
8. Final rule promotes safe use of dietary supplements. Food and Drug
Administration. Available at:
www.fda.gov/consumer/updates/dietarysupps062207.html. Accessed June 29, 2007.
9. Final rule for current good manufacturing practices (CGMPs) for dietary
supplements. Food and Drug Administration. Available at:
www.cfsan.fda.gov/~dms/dscgmps7.html. Accessed June 29, 2007.
10. Dietary supplement current good manufacturing practices (CGMPs) and
interim final rule (IFR) facts. Food and Drug Administration. Available at:
www.cfsan.fda.gov/~dms/dscgmps6.html. Accessed June 29, 2007.
11. Freking K. FDA issues new safety rules for vitamins. ABC News. Available
at: www.abcnews.go.com/Health/wirestory?id=3306953. Accessed June 29, 2007.
12. Zwillich T. FDA OKs dietary supplement regulations. WebMD. Available at:
June 29, 2007.
13. Gammon KS. FDA issues dietary supplement rules. Available at:
www.abcnews.go.com/Health/story?id=3307441&page=3. Accessed June 29, 2007.
14. Schardt D. Sex in a bottle. Center for Science in the Public Interest.
Available at: www.cspinet.org/nah/10_04/sexinabottle.pdf. Accessed June 29,
15. Enzyte male enhancement testimonials. Merazon Health Products, Inc.
Available at: www.enzyte-male-enhancement.com/google/testimonials.html.
Accessed June 29, 2007.
16. Cohen B, Schardt D. Letter to The Honorable Deborah P. Majoras. Center for
Science in the Public Interest. Available at:
www.cspinet.org/new/pdf/ftcenzyteletter.pdf. Accessed June 29, 2007.
17. Enjoy natural male enhancement! Berkeley Premium Nutraceuticals, Inc.
Available at: www.enzyte.com/nme.html. Accessed June 29, 2007.
18. Enzyte is trusted by over 3 million users and is the #1 selling supplement
in the world for natural male enhancement. Berkeley Premium Nutraceuticals,
Inc. Available at: www.enzyte.com. Accessed June 29, 2007.
19. Enzyte marketers sued. Quackwatch.com. Available at:
www.quackwatch.org/02ConsumerProtection/enzyte.html. Accessed June 29, 2007.
20. Blended for real results. Berkeley Premium Nutraceuticals, Inc. Available
at: www.enzyte.com/blend.html. Accessed June 29, 2007.
21. Frequently asked questions. Berkeley Premium Nutraceuticals, Inc.
Available at: www.enzyte.com/faq.html. Accessed June 29, 2007.
22. Paeth G. Enzyte maker under fire. The Cincinnati Post. Available
at: www.cincypost.com/2004/08/14/complaint081404.html. Accessed June 29, 2007.
23. "Smiling Bob" not smiling anymore. ConsumerAffairs.Com Inc. Available at:
www.consumeraffairs.com/news04/2006/03/smiling_bob.html. Accessed June 29,
24. Marketer of "enhancement" pill Enzyte to pay restitution, change practices
in settlement over negative option plan. Missouri Attorney General Jay Nixon.
Available at: www.ago.mo.gov/newsreleases/2006/030206b.htm. Accessed June 29,
25. Attorney General Lockyer announces settlement requiring maker of "Smiling
Bob" erectile dysfunction product to provide consumers restitution. California
Department of Justice. Available at:
Accessed June 29, 2007.
26. AG sues herbal supplement company for misleading Oregonians about the
pills' effectiveness and the "free" trial offer. Oregon Department of Justice.
Available at: www.doj.state.or.us/releases/2005/rel061605.shtml. Accessed June
27. Berkeley Premium Nutraceuticals, six individuals indicted for fraudulent
business practices in connection with sales of dietary supplements. Available
at: www.usdoj.gov/usao/ohs/Press/09-21-06.pdf. Accessed June 29, 2007.
28. Lau BH, Lau EW. Kyo-Green improves sexual dysfunction in men and women.
Med Sci Monit. 2003;9:PI12-18.
29. Ito T, Kawahara K, Das A, et al. The effects of ArginMax, a natural
dietary supplement for enhancement of male sexual function. Hawaii Med J
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