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Dietary supplements that advertise themselves as sexual enhancement products often contain unlisted ingredients that could be hazardous to the health of those who are unaware of their presence. The Food and Drug Administration finds it difficult to police this market sector comprehensively, so buyers should be cautious.
The Food and Drug Administration must approve all prescription medications before they can be sold in the United States. Drugmakers must conduct clinical trials that demonstrate their proposed new drugs are both effective and safe for consumer use. However, the FDA’s role in regulating dietary supplements differs significantly from its regulation of prescription drugs.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 prohibits manufacturers and distributors of dietary supplements from selling products that are “adulterated or misbranded.” In other words, the FDA doesn’t approve these products for sale but only becomes involved with a specific dietary supplement in response to complaints about the supplement’s purity and/or safety profile.
Sexual Enhancement Products
Among the thousands of so-called dietary supplements available to U.S. consumers are many that represent themselves as sexual enhancement products. These supplements may claim to overcome symptoms of male impotence, premature ejaculation, and/or loss of sexual desire. The FDA maintains a running list of “tainted sexual enhancement products” that have been reported to it by consumers or investigated by FDA staffers. Here are four of the more recent products subject to FDA alerts:
1. Rhino 69 Extreme 50000: Although it’s not included on the product’s list of ingredients label, this supplement contains tadalafil, the active ingredient in Cialis. Tadalafil could cause serious health problems if taken by men who also take nitrate-based drugs. Both drugs lower blood pressure and taken together could cause a potentially life-threatening episode of hypotension.
2. Red Zone Xtreme 3000: Like Rhino 69 Extreme 50000, this product contains tadalafil as an unlisted ingredient. In addition to its potentially dangerous interaction with nitrate-based drugs, tadalafil can cause a number of side effects, most of which are mild and may disappear upon continued use. These include back pain, diarrhea, dizziness, facial flushing, headache, muscle pain, nausea, and upset stomach. More serious side effects, although rare, can include an erection that lasts for more than four hours and a sudden decrease or loss of hearing or vision. Because the product doesn’t list tadalafil as an ingredient, doctors treating such side effects would not be aware that this undeclared ingredient was involved.
3. Black Lion Pill: This supplement, also advertised as a sexual enhancement aid, contains sildenafil, the active ingredient in Viagra, although it is not listed on the product’s label. Like tadalafil and all the other active ingredients in PDE5 inhibitors, the family of medications designed to treat male impotence, sildenafil interacts adversely with nitrates and can cause side effects similar to those caused by tadalafil.
4. Chao Jimengnan: This supplement also contains sildenafil, although its presence is not listed on the product’s label. Here again, the sildenafil can interact adversely with nitrates, which are widely used in the form of nitroglycerin tablets to relieve the discomfort of angina pectoris, or chest pain. Sildenafil can also cause certain side effects that consumers would not realize were caused by the chemical compound because it is an undeclared ingredient.
Therefore, because of the loose regulation of dietary supplements, consumers should exercise care in their use of such products. Checking out the FDA website for possible warnings could help you to avoid some questionable products, although the agency’s oversight of this market segment is far from comprehensive.
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