Tainted sex product notices back to pre-pandemic normTainted sex product notices back to pre-pandemic norm

In the past two months, the U.S. Food and Drug Administration has published 18 warning letters about sexual enhancement products found to be tainted with undeclared erectile dysfunction drugs.

That pace compares with 18 warning letters for tainted sex products issued in the first 10 months of 2024.

However, the 36 total notifications of 2024 pale in comparison to a spike in 2023, when 72 notices on tainted sex products were issued. 

According to the list that FDA maintains of such notices, that was by far the highest rate of sex product notices issued during one calendar year. The program started in 2012 and to date 445 such notices have been issued.

Over the years of the program the rate at which notifications have been issued has remained fairly constant, at an average of about 40 notices per year. The exceptions were the pandemic years of 2022 (two notices issued) and 2021 (one notice). It’s possible, then, that the high number of notices issued in 2023 was in part due to a backlog of activity from the pandemic.

Supposed 'herbal' products fortified with undeclared drugs

The products are often marketed as dietary supplements and usually feature suggestive and provocative names such as RIGIDRX, Rhino 69, WILDMAN and The Goat. The labels often claim the products to be “all natural” or “100% herbal.” Ingredients mentioned on labels include cordyceps, ginseng, licorice and cinnamon, just to name a few.

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But according to the FDA notices, what really makes these products work are the undeclared drug ingredients: sildenafil (the active ingredient in Viagra) and tadalafil (Cialis).

The concern expressed by the agency is that these drugs are not declared on the label and their dosages are unknown, presenting risks to unsuspecting consumers.

“FDA approvals of Cialis and Viagra are restricted to use under the supervision of a licensed health care professional. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates,” one such notice reads.

While those drug interactions are well established, Rich Kingston, PharmD, President of Regulatory and Scientific Affairs at SafetyCall International, said there are few case reports of people suffering harm from using the pills.

“The people who are using these are generally sexually active people who tend to be in a younger age group,” Kingston said, who is also a professor in the University of Minnesota School of Pharmacy.

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“But, as the advisory says, they still want people to be vigilant. These are drugs, so you must be careful,” he added.

Drugs have gone generic

Viagra and Cialis have long been off patent, and relatively low-cost generic versions are available. 

But a recent trade show that took place in September in Denver that was aimed at the alternative retail channel, the CHAMPS show, featured a whole section of male sexual enhancement products. That demonstrated a continuing thriving market for these products within that channel, which encompasses smoke and vape shapes, convenience stores and similar outlets.

Kingston speculated that the continued market for the products stems either from convenience or from the fact that this group of consumers is poorly informed about what generic drugs are available.

“You kind of wonder why these people bother, why they go around the current system,” he said.