3 new federal cases allege illegal distribution of male sexual enhancement pills falsely branded as "herbal" medicine

It's not clear if "Stiff Nights" is a "dietary supplement" as its maker claims, or a bad b-movie title, but in either case the FDA says men looking to "regain the thunder" should stay clear because the pill really contains sulfoaildenafil, an untested chemical similar to the active ingredient in Viagra, which can interact badly with nitrates and cause low blood pressure.FDA Warning.

Can a supplement improve a person’s sex life?

The Enzyte Scandal While many 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.

What are the alternatives to male enhancement pills?

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 Supplements 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. The marketing geniuses behind "Stiff Nights" also sell "Rock Hard Weekend." Same unregulated chemical, says the FDA, different laugh out loud brand.

It's not clear who Don Wands is or how he became so magical, but buy vardenafil 40mg the FDA didn't seem to care.

In August 2010, they told the manufacturer of this supplement to drop the magic act and take it off the shelves because the product's two main ingredients, hydroxyhomosildenafil and sulfoaildenafil, aren't listed on the box, aren't "supplements" and aren't really tested.FDA Warning. Magic Power Coffee's website says the extra mojo comes from honey goat weed and goji berries. If you wind up with Duro Extend in your stocking this year, you might want to send it back to Santa. The FDA recalled the product in early December 2010 because the "dietary supplement" is secretly supplemented with sulfoaidenafil, a drug similar to Viagra, but not tested. "This product is dangerous to consumers because it claims to contain only natural ingredients when it actually contains a prescription drug ingredient," says the FDA's warning letter. Dangerous interactions with nitrates and low blood pressure are possible. The FDA doesn't recommend hitting up Luong for pills, however. They say Vitalex's "all natural" and "herbal" concoction is really acetildenafil, another chemical similar to the drug in Viagra, but not tested. Eager men trying to get their hands on a box of Xiadafil VIP, might have to wait in line.

• Sildenafil citrate boosts erectile function by increasing penile blood flow.
• L-arginine supports nitric oxide production for vascular relaxation.
• Horny goat weed contains icariin which aids erectile quality.
• Tribulus terrestris may enhance testosterone and sexual desire.
• Ginseng reduces stress and improves endurance in sexual activity.
• Maca root supports increased libido and energy levels.
• DHEA helps restore hormone balance affecting sexual function.
• Zinc is important for testosterone production and fertility.
• Yohimbine improves blood flow and nerve function.
• Fenugreek may enhance testosterone and libido.
• Niacin helps improve vascular health necessary for erections.

Marshals seized almost $75,000 worth of it after the manufacturer refused an FDA request to recall it.

Supplement ingredients

Center for Science in the Public Interest. Cohen B, Schardt D. Letter to The Honorable Deborah P. Majoras. Enzyte is trusted by over 3 million users and is the #1 selling supplement in the world for natural male enhancement.

A Safer Solution

Marketer of "enhancement" pill Enzyte to pay restitution, change practices in settlement over negative option plan. Attorney General Lockyer announces settlement requiring maker of "Smiling Bob" erectile dysfunction product vardenafil oral to provide consumers restitution. AG sues herbal supplement company for misleading Oregonians about the pills' effectiveness and the "free" trial offer. Berkeley Premium Nutraceuticals, six individuals indicted for fraudulent business practices in connection with sales of dietary supplements. Kyo-Green improves sexual dysfunction in men and women. The FDA says the product's VIP power comes from hydroxyhomosildenafil, a drug similar to Viagra, but untested. Erectile dysfunction, also called ED, is trouble getting and keeping an erection that's firm enough for sex. ED is common, and treatments such as prescription medicines are available. But maybe you've seen advertisements for herbs or supplements that claim to boost sexual performance. Erectile dysfunction supplements and other natural remedies have long been used in various cultures.

But they haven't been studied or tested nearly as much as prescription medicines for ED.

What are men’s sexual health supplements?

The effects of ArginMax, a natural dietary supplement for enhancement of male sexual function. To comment on this article, contact editor@uspharmacist.com. Sexual male enhancement, as the euphemism goes, is big business. Last year, Viagra, the pharmaceutical market leader, raked in about $2 billion. That success has spawned a shadow industry of largely unregulated "natural male enhancement," or sex pill, products.

Top 9 Dangers of Sex Drive Pills

But according to the FDA, some of these products aren't natural, aren't tested and some might even be dangerous. Here's a list of 10 sex pill products the FDA issued health warnings about this year or told manufacturers to get them off the shelves. The issue, says the agency, is the product uses "sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra." Like Viagra, sulfoaildenafil can have dangerous interactions with other prescription drugs such as nitrates, and can cause dangerously low blood pressure. But because consumers think they are taking a "natural" product they are usually not under a doctor's care. Also, sulfoaildenafil has not undergone the same clinical trials as sildenafil, so all its effects are not known. They also can affect other medicines and health conditions. And the amount of the active ingredient can vary greatly from product to product.

Precision MegaTest 160 caps

Available at: Accessed June 29, 2007.7. Available at: Accessed June 29, 2007.8. Final rule promotes safe use of dietary supplements. Available the pink pill for women at: Accessed June 29, 2007.9. Final rule for current good manufacturing practices (CGMPs) for dietary supplements.

Health News

Dietary supplement current good manufacturing practices (CGMPs) and interim final rule (IFR) facts. Freking K. FDA issues new safety rules for vitamins. Zwillich T. FDA OKs dietary supplement regulations. That's why it's important to talk with your healthcare professional before you try a new supplement. Your healthcare professional can find out if it's safe for you and can recommend the right amount to take. Don't use supplements for ED that lack proven benefits and pose a potential risk for harm. Here's a guide to erectile dysfunction herbs and supplements: Many products that are sold without a prescription claim to be herbal forms of Viagra.

Some of these products contain various amounts of ingredients like those in prescription medicines. Such ingredients can cause dangerous side effects. Some products have the real medicine in them, and the medicine should be given by prescription only.

• Sildenafil enhances blood flow to the penis by relaxing vascular muscles.
• L-arginine boosts nitric oxide for better circulation and erection quality.
• Horny goat weed supports sexual health through its icariin compound.
• Tribulus terrestris is used to improve libido and testosterone.
• Ginseng reduces stress and promotes endurance enhancing sexual activity.
• Maca root supports libido and reduces sexual fatigue.
• DHEA levels decrease with age; supplements may improve sexual function.
• Zinc plays a significant role in testosterone production and fertility.
• Yohimbine can enhance erectile response by improving blood flow.
• Fenugreek may increase testosterone and sexual desire.
• Niacin aids erectile function by improving vascular health.

In the United States, the Food and Drug Administration has banned many of these products.

Be wary of 'herbal viagra'

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. Available at: Accessed June 29, 2007.2.

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New York, NY: The Haworth Press, Inc.; 2003.3. Andropause: endocrinology, erectile dysfunction, and prostate pathophysiology. Oral andro-related prohormone supplementation: do the potential risks outweigh the benefits? Available at: Accessed June 29, 2007.6. FDA warns consumers about dangerous ingredients in "dietary supplements" promoted for sexual enhancement.