What FDA actions and warnings have targeted sexual‑enhancement supplements in the last decade?
Executive summary
The FDA has spent the last decade repeatedly warning consumers about sexual‑enhancement supplements that contain undeclared pharmaceutical ingredients, issuing public notifications, warning letters and maintaining a tainted‑product database to track these alerts [1] [2]. Studies and FDA advisory pages show hundreds of products identified as adulterated—many with PDE‑5 inhibitors such as sildenafil—yet enforcement routinely stops short of wholesale recalls or criminal prosecutions, leaving ongoing public‑health risk [2] [3].
1. What the FDA actually does: notifications, warnings and a public database
The agency’s primary tools against tainted sexual‑enhancement supplements are public notifications and Medication Health Fraud warnings posted online, supplemented by a “Tainted Products Marketed as Dietary Supplements” (now Health Fraud Product) database that lists products tied to prior warnings, recalls and letters [1] [4]. These actions are designed to alert consumers and retailers that specific products “may be harmful due to hidden drug ingredients,” language used repeatedly in FDA notices for products marketed for sexual enhancement, weight loss or bodybuilding [5] [6].
2. Scale and trends over the last decade: hundreds of warnings, sexual‑enhancement leading the pack
Analyses of FDA warning data from 2007–2016 identified roughly 776 adulterated supplements, with sexual‑enhancement products comprising the single largest category (about 45.5% of identified products) and nearly half of warnings concerning sexual‑enhancement formulations specifically [2] [7]. Researchers found that the bulk of these alerts have concentrated in the latter half of that decade and that online sampling and international mail screenings were common detection routes [2].
3. Hidden ingredients and clinical dangers the FDA highlights
The most frequent undeclared ingredients in sexual‑enhancement supplements are prescription phosphodiesterase‑5 inhibitors (PDE‑5 inhibitors) such as sildenafil or analogues, sometimes in unknown potency or mixed with other active drugs—creating risks of dangerous interactions (for example, with nitrates) and unpredictable side effects [2] [8]. Peer‑reviewed work and FDA communications emphasize that products marketed as “all natural” have repeatedly tested positive for these prescription agents, posing cardiac and other systemic risks [9] [8].
4. Enforcement reality: warnings frequently issued, recalls and prosecutions less common
While the FDA can issue warnings and post alerts, its actions often rely on voluntary company cooperation for recalls; news reporting notes that the agency “can send warning letters” but that it’s often up to companies to carry out recalls, a gap that critics say limits consumer protection [3]. Empirical reviews show many products were associated with multiple FDA warnings over time and that new undeclared ingredients continued to be found even after initial alerts—evidence that formal warnings alone have not eliminated the problem [2].
5. Recent, named examples underscore persistence of the problem
Even in 2024–2025 the FDA continued to issue product‑specific advisories—such as ENDUREA (Jan 2024), WILDMAN (Dec 2024), and VITALITY and mR.7 SUPER 700000 —each described in agency notices warning consumers not to purchase or use items promoted for sexual enhancement due to hidden drug ingredients [6] [10] [11] [5]. Independent surveys and state laboratory testing confirm adulterated products remain available at retail and online despite prior FDA listings [12] [4].
6. How to read the FDA’s record and competing perspectives
The FDA’s pattern of frequent alerts and a maintained tainted‑product registry documents an ongoing adulteration problem and a public‑health rationale for warnings, while industry and some critics point out limits in the agency’s power to compel recalls or consistently police online marketplaces—so the tension is between identification/notification and the harder work of removal and prosecution [3] [2]. Published studies cited here argue that—even with robust warning volumes—active pharmaceutical ingredients continue to be found in supplements marketed for sexual enhancement, underscoring the persistence of risk [13] [2].