The FDA Says Those OTC Sexual Enhancement Supplements Will Do More Harm Than Good

The FDA Says Those OTC Sexual Enhancement Supplements Will Do More Harm Than Good

October 5, 2015

Gentlemen, we're sorry to inform you, but that pill you bought at the gas station will likely do more harm than good.

The Food and Drug Administration (FDA) is advising consumers to stay clear of foods or dietary supplements that promise to enhance a man's sexual performance or increase sexual stimulation. These supplements often contain undisclosed medications of questionable origins that can have life-threatening side effects.

While these supplements are marketed as all natural, FDA lab tests found that 300 of these products contain undisclosed drug ingredients. Many of these supplements include the same active ingredients found in FDA-approved prescription drugs for erectile dysfunction. Although it might seem like a good way to avoid a doctor copay and a trip to the pharmacy, these supplements may have higher-than normal dosages of the approved medication or they may be combined with other unapproved medications.

For example, writes an FDA in a consumer alert, one of the tainted products tested by its lab included 31 times the prescription dose of tadalafil, the active ingredient in Cialis, in combination with dapoxetine, an antidepressant the isn't approved by the FDA.

"We're finding an alarming number of these products sold online and in retail stores," FDA national health fraud coordinator Gary Coody said in a statement. "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. Consumers have no way of knowing which drugs or ingredients are actually in the product just by reading the ingredients on the label."

Along with the health risks that come with high medication dosages and sketchy, unapproved medications, these drugs can have life-threatening side effects if they are taken with certain medications. For example, sildenafil, the active ingredient in Viagra, paired with nitrates can lower blood pressure to an unsafe level. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed nitrates.

Unlike FDA-approved medications, supplements are not regulated by the FDA and don't have to be tested for effectiveness or safety before they're sold. By law, it's the company's responsibility to make sure that its products are safe and their claims are true. Many of these supplements, however, are made overseas in facilities that do not undergo FDA inspection.

The FDA can act if the company is found to be using prescription drugs without FDA approval, if label claims are incorrect, or if there is otherwise a reason to believe that a supplement isn't safe or not manufactured properly.

The FDA says to 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