Which sexual‑enhancement supplements have received FDA warnings for adulteration or false claims?
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Executive summary
The FDA has repeatedly warned that dozens—and by some counts hundreds—of products marketed as sexual‑enhancement “supplements” are adulterated with undeclared prescription drugs or make false claims; specific named products in recent FDA notifications include mR.7 SUPER 700000, VITALITY, and Ram It & To The Moon, and agency databases and studies document hundreds more tainted formulations over years [1] [2] [3] [4]. Academic analyses and FDA pages warn that the problem is concentrated in male enhancement pills and single‑use blister‑pack products sold online or at corner stores and that many contain PDE‑5 inhibitors such as sildenafil or tadalafil not listed on labels [5] [4] [6].
1. FDA’s public list and the scale of warnings: more than anecdotes
The FDA maintains a Health Fraud/Tainted Products database and has issued hundreds of warnings, advisories, recalls and press notices about adulterated dietary supplements—from 2007–2016 the agency identified 776 adulterated supplements and found sexual‑enhancement products to be the largest category implicated (353 of 776), a pattern reinforced by ongoing FDA public notifications [5] [4].
2. Recent named products the FDA singled out
In specific public notices the FDA warned consumers about mR.7 SUPER 700000, a male sexual‑enhancement product sold online that the agency said may be harmful due to hidden drug ingredients [1], and VITALITY, another sexual‑enhancement product promoted on zen‑herbs.com that the FDA advised consumers not to buy because of undisclosed drug chemicals [2]. The FDA’s recall announcements have also named products such as Ram It & To The Moon after laboratory analysis found sildenafil and tadalafil in the product [3].
3. The usual adulterants: PDE‑5 inhibitors and analogues
Multiple analyses and FDA testing show a repeating pattern: purported “herbal” or “natural” sexual‑performance supplements are frequently tainted with phosphodiesterase‑5 (PDE‑5) inhibitors—sildenafil, tadalafil, vardenafil—or analogues of those drugs, sometimes at high or inconsistent doses that create safety risks and dangerous interactions with nitrates [4] [7]. Academic surveys in the U.S. and Europe have documented that adulterants can change over time as manufacturers attempt to evade detection [8] [9].
4. Where these pills are sold and why detection lags
FDA sampling and third‑party studies find adulterated sexual‑enhancement products most often online, through international mail shipments, and in single‑serving blister packs sold at gas stations or corner stores—formats that are harder to trace back to repeat customers—while products in bottles and sold at pharmacies are less likely, though not immune [4] [6]. FDA enforcement can issue warnings and request recalls, but recalls are often voluntary and product reformulation or removal from marketplaces is uneven [10] [11].
5. Industry pushback and the enforcement gap
Trade groups and some sellers argue that not all claims on supplements are equivalent to drug claims and criticize delays or selective actions; reporting indicates the FDA first identified several tadalafil‑tainted products in mid‑2023 but moved later to notify large platforms such as Amazon, prompting industry calls for swifter platform enforcement [11]. The FDA and researchers counter that market incentives—high profit and low regulatory barriers—drive intentional adulteration and that many companies do not voluntarily recall tainted lots after agency notice [10] [12].
6. Practical takeaway: names, patterns and limits of reporting
The clearest, documented examples in recent FDA notices and recalls are mR.7 SUPER 700000 and VITALITY (public notifications), and Ram It & To The Moon (a recall for sildenafil/tadalafil contamination), while dozens to hundreds of other brand‑named supplements appear across the FDA database and in peer‑reviewed analyses that catalog adulterants and repeated warnings [1] [2] [3] [4] [12]. This reporting reflects the FDA’s public notices and academic compilations; it does not purport to be an exhaustive list of every tainted product at a given moment because the agency’s database and enforcement actions evolve over time [5] [4].