The Food and Drug Administration (FDA) caused a number of over the counter medications to be recalled when it cited them for containing unsafe ingredients. Several of the defective products could pose a serious threat to people with heart conditions, high blood pressure or a tendency toward seizures. The citation targeted several dietary supplements that claim to increase libido and enhance sexual performance. In some cases, the products were recalled due to false claims about the ability of the supplements to treat medical conditions such as erectile dysfunction. In other cases, the supplements were removed after they were found to contain prescription drug ingredients.
The FDA carefully regulates prescription drugs. The regulation of over the counter supplements is more difficult. With no requirement to conduct clinical trials or prove that their products offer any benefit, the makers of dietary supplements may ignore the potential harm they can cause to consumers. At least six companies in Florida alone have been cited recently for improper conduct. Testing of sexual enhancement supplements discovered ingredients such as sulfoaildenafil, sildenafil, tadalafil and yohimbe. All of these ingredients are regulated due to harm they pose if given in the wrong doses or to people whose health is compromised.
Consumers may mistake lack of regulation for a guarantee of safety. How could a company sell a dangerous product at the counter of a gas station or convenience store? The manufacturers of these products rarely identify themselves on the packaging. The law does not require manufacturers to disclose their information on the packaging.
The FDA’s increased scrutiny may protect potential victims. For now, it is important for consumers with heart conditions or who are taking any other medication to speak to a doctor before using these supplements.
Source: Sun Sentinel, “FDA cracks down on over-the-counter sex pills,” by Diane C. Lade, September 15, 2011.