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 agency concluded that the claims made for these products were claims made for the undeclared nondietary supplement components, making them illegal drugs. 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. 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. The agency also urges consumers to consult a qualified practitioner for treatment of impotence, rather than placing one's trust in their bogus remedies. There is no herb or 'all natural' substance proven to cure impotence. When impotence cures are said to be 'herbal' or 'all natural,' the product should be ignored. Furthermore, claims providing very high rates of success are often bogus. When a consumer sees the phrase 'clinical studies prove it works,' caution is in order, as these claims are often false. Some manufacturers of impotence cures claim that their product is 'scientifically proven' to work. Consumers should check with a physician to verify the legitimacy of these organizations.

Some manufacturers create phony 'clinics' and fake 'institutes' solely to promote bogus impotence cures. Products advertised as 'breakthroughs' in the treatment of impotence mandate double checking with a physician for legitimacy.

Products advertised as effective for treating impotence without a physician's prescription should be ignored, as they cannot cure the condition.

The agency clarified several issues and disspelled a great deal of manufacturer hype: The FTC issued a consumer alert entitled The Truth About 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. As millions of baby boomers are currently experiencing andropause, marketers offer hundreds of products allegedly beneficial in reversing impotence and enhancing male sexual performance. Patients undergoing andropause often do not choose these therapies, opting instead to try dietary supplements. Legitimate medical interventions include testosterone, Viagra, Caverject, and devices inserted into the penis. The penis may gradually disengorge during intercourse. Males cannot achieve an erection or cannot sustain one for a sufficient time to complete sexual intercourse. ĭuring andropause, the male's serum testosterone levels fall, leading in many cases to erectile dysfunction. 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. 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. Products promising 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. 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 these products. 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. Many people do not realize, however, that the products are not proven safe for use. 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. American consumers are exposed to an overwhelming sea of advertising for dietary supplements and homeopathic products. According to the National Institute for Aging, quackery is at an all-time high.

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