FDA Detects Undeclared Sildenafil and Tadalafil in OTC Male Sexual Enhancement Products

FDA Detects Undeclared Sildenafil and Tadalafil in OTC Male Sexual Enhancement Products

By Helen Whitaker, Senior Editor

The FDA routinely identifies and alerts consumers that many male enhancement dietary supplements labeled as “natural” or “herbal” contain undisclosed prescription-strength pharmaceutical ingredients, primarily PDE5 inhibitors such as sildenafil, tadalafil, and their analogs [1][2]. These hidden compounds can cause dangerous interactions (especially with nitrates), leading to severe hypotension, cardiovascular events, or other adverse effects. The agency issues public notifications via its recalls and safety alerts system because these products are sold over-the-counter without approval or adequate labeling [3].

Data from FDA monitoring between 2023 and 2024 show that sildenafil (the active ingredient in Viagra), tadalafil (the active ingredient in Cialis), vardenafil, and structural analogs appear frequently as undeclared ingredients [1].

Undeclared Ingredients Detected

The FDA has documented sildenafil, tadalafil, vardenafil, and structural analogs as commonly found undeclared ingredients in male sexual enhancement products sold as dietary supplements [1]. These synthetic PDE5 inhibitors are not disclosed on product labeling despite their pharmaceutical potency.

Products are widely available online, in retail stores, and through international shipments, and are often labeled “all natural” [1].

Health Risks Associated With Hidden PDE5 Inhibitors

FDA reports indicate that the primary health risk from these hidden PDE5 inhibitors is a significant drop in blood pressure when combined with nitrates, along with risks of heart attack, stroke, or priapism [2]. Such interactions are linked to the pharmacological action of the undeclared compounds.

These risks are associated with use in individuals who may be taking medications for cardiovascular conditions or who have underlying health factors, according to agency safety information [2].

FDA Identification Process and Enforcement Actions

The FDA identifies tainted supplements through sampling, consumer reports, and marketplace monitoring, and has issued hundreds of alerts since the early 2000s regarding products marketed illegally as unapproved drugs [3]. These actions occur under the agency’s authority over dietary supplement safety and medication health fraud [2][3].

The agency publishes notifications on its Recalls, Market Withdrawals, & Safety Alerts page to inform the public of identified products [1].

What this means

The findings indicate that claims of “all natural” or “herbal” composition do not ensure the absence of synthetic PDE5 inhibitors. FDA data link these undeclared ingredients to potential cardiovascular interactions, particularly in combination with nitrates. Regulatory alerts reflect only those products that have been sampled or reported; the agency’s database provides one record of identified cases. The information underscores that these products are classified as unapproved drugs when they contain hidden pharmaceutical ingredients.

Limitations

New tainted products enter the market continuously; no comprehensive testing exists for every supplement sold. FDA alerts reflect only sampled or reported products. This article does not provide individualized medical advice and cannot replace consultation with a healthcare provider. Data on actual adverse event incidence is limited to voluntary reporting systems.