FDA Warns Against Male Enhancement Products

Natural male enhancement supplements may contain undisclosed drug ingredients and can endanger health

/ Author:  / Reviewed by: Jennifer Gershman, PharmD, CPh

(RxWiki News) Before you try an "all natural" male enhancement supplement, you may want to take a closer look.

So far, the US Food and Drug Administration (FDA) has found almost 300 natural male enhancement products containing undisclosed drug ingredients. These products often included the same active ingredients found in prescription drugs approved by the FDA to treat erectile dysfunction (ED), such as Cialis, Viagra and Levitra.

But in some cases, these products also included untested combinations of undisclosed ingredients or excessively high doses — both situations that could pose serious health risks to consumers. For instance, one of these products contained 31 times the recommended dose of tadalafil (the active ingredient in Cialis) in combination with dapoxetine (an antidepressant not approved by FDA).

"It is somewhat ironic that supplements that are sold over the counter tend to be thought of as being safe and sometimes are even thought of as being safer than FDA-approved medications by many people," said Parviz K. Kavoussi, a urologist and expert in male infertility and sexual medicine in Austin, TX, in an interview with RxWiki News. "The fact is that such supplements do not go through the rigorous basic science, animal, and human clinical trials and testing that are required for a drug to become FDA-approved."

Dr. Kavoussi added, "It is really difficult to get a drug through FDA approval, so that is why most health care providers sleep much better at night with our patients on products that we know much more about the safety and efficacy of to the best of our ability. Unfortunately, with over-the-counter supplements, the manufacturers do not have to put how much of what components are in it or even what all components are in it."

According to the FDA, some consumers may mistakenly believe that these products are safe because they are often marketed as "all natural" or "herbal" alternatives to prescription ED drugs. But even cautious consumers may not be able to tell if these products contain potentially hazardous ingredients because their labels often don't list them.

"We’re finding an alarming number of these products sold online and in retail stores," said FDA National Health Fraud Coordinator Gary Coody, RPh, in a press release. "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."

According to these researchers, one of the biggest risks for consumers is the possibility that undisclosed drug ingredients could interact dangerously with other medications they're taking.

"A doctor needs to evaluate your total medical condition to know whether a particular medication is safe for you to use," said M. Daniel Dos Santos, PharmD, PhD, of the FDA’s Division of Dietary Supplement Programs, in a press release. "If consumers are taking products that have undeclared drug ingredients, this leaves patients vulnerable to potentially serious drug interactions."

Unlike prescription and some nonprescription drugs, dietary supplements can legally be marketed without an FDA efficacy and safety evaluation. Therefore, it's the company’s responsibility to make sure its products are safe for consumers.

Despite efforts from the FDA to stop the sale of illegal products and have them recalled or destroyed, many of these supplements are still on the market.

The FDA warns consumers to be wary of products that promise quick results, are sold in single servings, are marketed as alternatives to FDA-approved prescription drugs, are advertised via spam or unsolicited emails, or have labels that mimic FDA-approved products.

"These products are not harmless or recreational," Dr. Dos Santos said. "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."

If you suspect that a product marketed as a dietary supplement may be tainted or responsible for any illness or injury, you can report it to the FDA by calling 1-800-FDA-1088 or visiting the FDA's website.

The US Food and Drug Administration funded this research. No conflicts of interest were disclosed.

Review Date: 
October 12, 2015
Last Updated:
October 22, 2015