Some over-the-counter sexual enhancement and energy products are being sold with hidden prescription drugs and other undisclosed ingredients, the U.S. Food and Drug Administration (FDA) has warned, prompting fresh alerts to consumers and health professionals.
In a notice on its website, the agency said it has identified products marketed for sexual enhancement and energy that contain ingredients not listed on their labels, including prescription drug components. The FDA emphasized that these hidden substances can pose serious health risks, especially for people with underlying conditions or those taking other medications.
What the FDA is warning about
According to the FDA notice, the agency has received and reviewed reports involving sexual enhancement and energy products that were promoted as dietary supplements or natural remedies but were later found to contain undeclared active ingredients.
The FDA stated that some of these products include components of prescription drugs used to treat conditions such as erectile dysfunction. Because these substances are not disclosed on the label, consumers cannot know what they are taking or how the products might interact with other medicines or health conditions.
The agency’s notification explains that products with undisclosed prescription ingredients do not meet the legal definition of a dietary supplement. Instead, they are considered unapproved drugs, which have not been evaluated by the FDA for safety, effectiveness, or quality.
Why hidden ingredients are dangerous
In its communication, the FDA highlighted several ways hidden drug ingredients can endanger consumers:
Drug interactions: Undeclared prescription components can interact with medications a person is already taking. The FDA noted that this is a particular concern for people using drugs for heart disease, high blood pressure, or diabetes, because some erectile dysfunction drugs can dangerously lower blood pressure when combined with certain heart medicines.
Underlying health conditions: The agency warned that people with cardiovascular disease or other chronic illnesses may be at higher risk of serious side effects if they unknowingly take a product containing a prescription-strength active ingredient.
Uncontrolled dosing: Because the hidden ingredients are not listed, consumers and health professionals cannot judge the dose or frequency of use. The FDA notice explained that this can lead to overdosing or prolonged exposure without any medical supervision.
False sense of safety: The FDA stressed that products marketed as “natural,” “herbal,” or “dietary supplements” may appear safer to consumers, even when they contain undisclosed drug substances.
The agency’s warning makes clear that these risks are not theoretical. Its notice references testing and investigations that revealed undeclared active ingredients in products sold for sexual enhancement and energy.
How the FDA identifies and responds to risky products
The FDA explained that it identifies problematic sexual enhancement and energy products through several channels, including product testing, adverse event reports, and surveillance of items sold online and in stores.
When the agency finds a product with hidden drug ingredients, it can take a range of actions, which may include public notifications, warning letters to companies, product seizures, or working with firms on voluntary recalls. The specific enforcement step depends on the product, the severity of the risk, and the company’s response.
In this latest notification, the FDA focused on informing consumers, healthcare providers, and retailers that some products in this category have been found to contain undisclosed ingredients. The agency urged people to be cautious about sexual enhancement and energy products that promise rapid or dramatic effects, especially when they are sold as dietary supplements.
The FDA also pointed readers to its online resources that list products found to contain hidden drug ingredients. These lists are updated as new information becomes available.
What consumers and clinicians are being urged to do
The FDA’s notice includes specific guidance for consumers and health professionals.
For consumers, the agency advised:
Be skeptical of products that sound too good to be true. The FDA warned that items claiming to work “instantly,” to be “guaranteed,” or to provide effects similar to prescription drugs may be more likely to contain undeclared ingredients.
Check FDA resources. The agency encouraged consumers to consult its public lists of tainted sexual enhancement and energy products before using items in these categories.
Talk with a healthcare provider. The FDA recommended that people discuss sexual health and energy concerns with a clinician rather than relying on unverified over-the-counter products.
Report problems. Consumers who experience side effects or suspect a product may be contaminated or mislabeled are urged to report it through the FDA’s MedWatch system, the agency’s safety reporting program.
For healthcare professionals, the FDA suggested they:
Ask patients specifically about use of over-the-counter sexual enhancement and energy products.
Consider the possibility of undeclared drug ingredients when evaluating unexplained side effects, particularly cardiovascular events or changes in blood pressure.
Report suspected adverse events or product quality problems to the FDA.
The agency’s notice underscored that clinicians may not be aware patients are using these products, since many people consider them supplements rather than medications.
What is at stake
The FDA framed the issue as a matter of patient safety and informed choice. When sexual enhancement and energy products contain hidden prescription drugs or other undisclosed ingredients, consumers lose the ability to make informed decisions about what they are taking.
The agency’s notification stressed that these products have not gone through the FDA’s review process for prescription drugs, which is designed to evaluate safety, effectiveness, and manufacturing quality. Without that oversight, there is no assurance that the dose is consistent, that contaminants are absent, or that the product will behave as expected in the body.
By publicly flagging sexual enhancement and energy products with hidden ingredients, the FDA is signaling to consumers and health professionals that extra caution is warranted in this corner of the marketplace. The agency indicated that it will continue monitoring products in this category and updating its notifications as new information emerges.
For now, the FDA’s central message is straightforward: some sexual enhancement and energy products sold as supplements or natural remedies have been found to contain undisclosed prescription drug ingredients, and using them can carry real medical risks. Consumers are urged to involve healthcare professionals in decisions about these products and to rely on FDA information when assessing their safety.
