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FDA Warns About the Dark Side of Male Sex Supplements

Tim Boyer's picture
FDA sex supplement warning

Here are 6 red flags you should look for before considering trying a male sex supplement that promises to give your sex life a boost.


According to a recent announcement by the FDA, men need to be wary of falsely marketed dietary supplements that promise to enhance your sexual performance. The truth of the matter is that many of those sex supplements contain hidden drug ingredients that could ruin their health.

So how many is “many”? Thus far, the FDA reports finding undisclosed ingredients in nearly 300 products targeting men and sexual health. Among the hidden ingredients are those found in the legal and safe prescription erectile dysfunction drugs like Viagra, Levitra and Cialis. What makes the non-prescription sex supplements so dangerous is that not only may they contain excessively high doses of the active ingredients used in safe erectile dysfunction drugs, but may also include combinations of other drug ingredients turning that sex supplement into a dangerous drug cocktail.

One example is a sex supplement the FDA found that contained 31 times the prescription dose of tadalafil (the active ingredient in Cialis), in combination with dapoxetine, an antidepressant that is not approved by FDA. Another example is the detected presence of sildenafil―the active ingredient in Viagra―that in addition with certain drugs such as those used to treat diabetes, high blood pressure, high cholesterol and heart disease—all of which contain nitrates―could cause a fatal drop in blood pressure.

“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,” says Gary Coody, R.Ph, the FDA’s national health fraud coordinator.

To convince men to try their products, marketers typically mislabel the products as “all-natural” or “herbal” alternatives to FDA-approved prescription drugs for the treatment of erectile dysfunction.

“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 Coody. “Consumers have no way of knowing which drugs or ingredients are actually in the product just by reading the ingredients on the label.”

Sex Supplement Red Flags to Watch For

The FDA tells men that any of the following 6 conditions should be considered a red flag when considering buying a sex supplement:

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Red Flag #1: The sex supplement promises quick results (within 30 to 40 minutes).

Red Flag #2: The sex supplement is advertised as an alternative to FDA-approved prescription drugs.

Red Flag #3: The sex supplement is sold in a single serving pack.

Red Flag #4: The sex supplement is advertised via spam or unsolicited emails.

Red Flag #5: The sex supplement’s labels are printed in a foreign language.

Red Flag #6: The sex supplement’s labels have directions and warnings that mimic those found on FDA-approved products.

“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.”

If you believe that you have suffered an illness or injury that you believe is related to the use of a dietary supplement, contact the FDA at 1-800-FDA-1088 1-800-FDA-1088 for free.

For more about FDA warnings on supplements, here is a recent report about the FDA and Justice Department clamping down on this maker of potentially dangerous supplements.

Reference: FDA Consumer Update ― "All Natural" Alternatives for Erectile Dysfunction: A Risky Proposition Oct. 2015