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'All Natural' Alternatives for Erectile Dysfunction: A Risky Proposition

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Men, beware! Products falsely marketed as “dietary supplements” or “foods” that promise to enhance your sexual performance or increase sexual stimulation might contain hidden drug ingredients or other undisclosed ingredients — and can endanger your health.

Thus far, FDA lab tests have found that nearly 300 of these products contain undisclosed drug ingredients. These can include the same active ingredients found in prescription drugs that are FDA-approved for the treatment of erectile dysfunction (ED), such as Viagra, Cialis and Levitra. Not only do these products contain undisclosed drug ingredients, but they also sometimes may include combinations of undisclosed ingredients or excessively high doses, both potentially dangerous situations.

Even a cautious consumer can’t tell that these products are, in fact, tainted with undisclosed drug ingredients, because their labels do not list the potentially hazardous ingredients, says M. Daniel Dos Santos, Pharm.D., Ph.D., of FDA’s Division of Dietary Supplement Programs. Consumers may be misled to believe these products are safe because their labeling often suggests they are “all-natural” or “herbal” alternatives to FDA-approved prescription drugs for the treatment of ED.

“We’re finding an alarming number of these products sold online and in retail stores. They’re often sold in single-serving sizes in gas stations or vending machines. We’ve seen pills, coffees, chewing gum and dissolvable oral strips that contain hidden drug ingredients or untested chemicals,” says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Consumers have no way of knowing which drugs or ingredients are actually in the product just by reading the ingredients on the label.”

Beware of products that:

  • Promise quick results (within 30 to 40 minutes)
  • Are advertised as alternatives to FDA-approved prescription drugs
  • Are sold in single servings
  • Advertise via spam or unsolicited emails
  • Have labels written primarily in a foreign language
  • Have directions and warnings that mimic FDA-approved products

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A Drug Cocktail

Even more troubling is that many of the hundreds of products FDA has tested contained high doses of undeclared (or hidden) mixtures of different drug ingredients. For example, one of these tainted products included 31 times the prescription dose of tadalafil (the active ingredient in Cialis), in combination with dapoxetine, an antidepressant that is not approved by FDA.

“Some of these products have as many as six different ingredients contained in FDA-approved prescription drugs and analog of those ingredients, which are similar compounds of the drugs. We don’t know what danger this poses because these combinations have never been studied before they’re sold to unsuspecting consumers,” Coody says.

Unlike prescription and some non-prescription drugs, many dietary supplements may be legally marketed without a prior FDA evaluation of their safety and effectiveness. FDA typically investigates dietary supplement products after they are marketed, for example, as a part of routine or for-cause facility inspections, or after it receives reports associating them with adverse events. Under the law, it is the company’s responsibility to make sure that its products are safe and that the claims they make are true.

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Risky Interactions

The big risk for unsuspecting men is that many of the unlabeled drug ingredients in these deceptive products can interact dangerously with other drugs they are taking, such as heart disease medicines.

For example, taking a product that contains sildenafil (the active ingredient in Viagra) in addition to certain drugs containing nitrates may lower blood pressure to an unsafe level. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed drugs containing nitrates, and men with those conditions commonly suffer from erectile dysfunction.

“A doctor needs to evaluate your total medical condition to know whether a particular medication is safe for you to use. If consumers are taking products that have undeclared drug ingredients, this leaves patients vulnerable to potentially serious drug interactions,” Dos Santos says.

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Unknown Contaminants

Erectile dysfunction is a medical condition. Because dietary supplements can’t legally claim to prevent, diagnose or treat a medical condition or a disease, the “alternative” ED products are often advertised for “sexual enhancement.” Their availability in the market doesn’t make them safe.

“These products are not harmless or recreational,” Dos Santos warns. “They often claim to have the same effects as drugs that are FDA-approved for the treatment of ED, such as Cialis and Viagra, promising to work quickly — within 30 to 40 minutes. That’s a red flag.”

In many cases, we don’t know where or how these products are manufactured, says Brad Pace, regulatory counsel at FDA’s Health Fraud Branch. Many of these products are produced overseas in facilities that have not yet been inspected by FDA.

“Some of the ingredients in these products have chemicals that have never undergone any type of safety analysis in the United States. You just don’t know what you’re getting,” Pace says.

FDA issues numerous alerts warning consumers and health care professionals about potentially dangerous products. It also works to stop the sale of illegal products and have them voluntarily recalled or destroyed. As part of this mandate, FDA sends advisory letters to companies warning that they are breaking the law and must stop. Failure to cease illegal behavior could lead to seizures, import alerts, injunctions, recalls and criminal prosecutions. An import alert allows FDA to detain, without physically examining, products that appear to violate certain parts of the Food, Drug, and Cosmetic Act.

Nonetheless, some products are still in the marketplace. That’s why consumers should consult their health care professional before taking a new supplement.

If you suspect that a product marketed as a dietary supplement may be tainted, report it to FDA. You or your health care professional can also report an illness or injury you believe to be related to the use of a dietary supplement by calling 1-800-FDA-1088 or visiting FDA online.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

October 1, 2015

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