What FDA warnings have been issued about sexual‑enhancement supplements since 2011?
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Executive summary
Since 2011 the FDA has repeatedly warned that dozens—indeed hundreds—of sexual‑enhancement supplements are adulterated with undeclared prescription drugs or analogues, issuing public notifications, warning letters and recall notices and maintaining a running online database of tainted products [1] [2] [3]. The agency’s alerts show a persistent pattern: products marketed as “natural” often contain PDE‑5 inhibitors such as sildenafil (or analogues), warnings have continued into 2024–2025 for named brands, and enforcement faces limits because adulterated products keep reappearing and companies must often voluntarily recall [2] [4] [5] [6] [7].
1. What the FDA has warned about — scope and common hidden ingredients
The FDA’s public notifications and its Health Fraud/Tainted Products database make clear that sexual‑enhancement supplements are the single largest category of tainted dietary supplements identified by the agency, with more than 350 different sexual‑enhancement products found to contain unapproved pharmaceutical ingredients over multi‑year reviews [3] [8]. Peer‑reviewed analyses of FDA warnings from 2007–2016 found 353 adulterated sexual‑enhancement products and showed the most common adulterants were phosphodiesterase‑5 inhibitors (PDE‑5 inhibitors) such as sildenafil or sildenafil analogues, accounting for nearly half of sexual‑enhancement adulterants [2] [9].
2. Notable clustered warnings and the 2016 announcement
The FDA has periodically issued cluster warnings; for example, in January 2016 the agency announced warnings against 40 products marketed as dietary supplements that contained undeclared PDE‑5 inhibitors, illustrating how the agency sometimes acts en masse when widespread adulteration is detected [4]. Scholarly reviews cite that FDA warnings include varied document types—public notifications, warning letters, recalls and press announcements—and that certain products have been named in multiple, separate warnings, indicating persistent market presence despite earlier alerts [2].
3. Recent named product alerts (2024–2025) and continuing vigilance
The FDA’s Medication Health Fraud notifications continue to name specific products: ENDUREA was the subject of a January 2, 2024 consumer advisory for hidden drug ingredients [5], VITALITY drew a February 10, 2025 notification [6], and mR.7 SUPER 700000 was singled out in a November 21, 2025 alert warning consumers not to purchase or use it because of hidden pharmaceutical chemicals [10]. The agency’s ongoing subscription notifications underscore that the problem is current, not historical, and the FDA explicitly warns that many such products are marketed as “all natural” despite containing undeclared drugs [1] [10].
4. Regulatory and enforcement realities — why warnings don’t end the problem
Analyses and news reporting emphasize enforcement constraints: the FDA can issue warnings, import alerts and request voluntary recalls, but actual removal often depends on firms’ compliance and marketplace dynamics; journalists and experts note that the agency’s alerts are numerous but companies are responsible for recalls and adulterated products can reappear online or change adulterants to evade detection [7] [11] [12]. Academic work documents that some products were listed in multiple warnings and that adulterants shifted over time—tactics consistent with attempts to evade routine screening [2] [12].
5. Health risks, criminal cases, and the broader evidence base
The FDA’s pattern of warnings is grounded in measurable risks: studies show undeclared APIs (active pharmaceutical ingredients) in sexual‑enhancement supplements can cause serious adverse effects, particularly when consumers take nitrates or other interacting drugs, and enforcement has occasionally escalated to criminal investigation and Department of Justice actions—e.g., a 2019 DOJ plea related to illegal importation and sale of tainted sexual‑enhancement supplements covering activity from 2011–2017 [4] [9] [11]. Peer‑reviewed literature and public‑health reviews repeatedly warn that the quantity and quality of hidden prescription drugs in these products are variable and potentially dangerous [3] [9].
6. What reporting does not settle and alternative perspectives
Available sources document the FDA’s warnings and the scientific findings of adulteration, but they do not present detailed industry rebuttals or the full legal outcomes for every warninged product; therefore reporting cannot quantify how many alerts led to lasting market removal versus rebranding or online persistence without further investigation [1] [2]. Consumer‑safety advocates frame FDA warnings as essential evidence that supplements marketed for sexual enhancement are high‑risk, while some industry stakeholders argue for clearer testing standards and faster enforcement mechanisms; the public record shows both persistent adulteration and regulatory limits to immediate market control [7] [11] [12].