FDA Issues Warning Against Honey-Based Sexual Supplements
The FDA warns against honey-based sexual supplements with hidden drugs, urging men with erectile dysfunction to consult doctors for proper diagnosis, treatment, and monitoring of potential side effects.
Leading Honey-Infused Intimate Enhancers Might Not Be As Wholesome As They Seem
The United States Food and Drug Administration (FDA) recently issued cautionary notices to four manufacturers of honey-derived sexual performance-boosting supplements. After investigation, the FDA discovered that these products contain the same active components found in Cialis and Viagra—prescription medications formulated to address erectile dysfunction.
In a public announcement made on Tuesday, the FDA revealed that their internal laboratory examinations detected the presence of tadalafil (Cialis) and sildenafil (Viagra) in several items, such as "Royal Honey for Him" and "X Rated Honey for Men." In addition, the FDA emphasized the potential hazards these pharmaceuticals pose to individuals concurrently consuming other prescription drugs containing nitrates (e.g., nitroglycerin) and those prescribed to manage diabetes, high cholesterol, and cardiovascular diseases. Such interactions could lead to critically low blood pressure levels.
Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs, expressed concern via the FDA's release, stating, "Contaminated honey-based products like these are dangerous because consumers are likely unaware of the risks associated with the hidden prescription drug ingredients in these products and how they may interact with other drugs and supplements they may take."
The United States Food and Drug Administration (FDA) has identified four enterprises: Thirstyrun LLC (operating under the alias US Royal Honey LLC), MKS Enterprise LLC, Shopaax.com, and 1am USA Incorporated doing business as Pleasure Products USA.
As per the FDA's disclosure, these companies have been marketing honey-infused aphrodisiac supplements through online platforms and potentially in select brick-and-mortar retail establishments.
The implicated organizations have been given a 15-day window to either rectify the concerns associated with their merchandise or present justifiable evidence demonstrating that their offerings do not breach existing regulations. In the event of non-compliance, the FDA has indicated its intent to pursue legal recourse, which may encompass confiscating the products in question, as outlined in the official press statement.
An Unregulated Industry
Dietary supplements inhabit a largely unmonitored marketplace, as they do not undergo evaluation by the Food and Drug Administration (FDA).
One such supplement, "Royal Honey for Men," asserts that it confers unparalleled vigor, proclaiming itself as "the ultimate and most potent natural source of sexual prowess and testosterone enhancement," per its promotional materials. The product's ingredient list features prominent components often found in testosterone boosters and sexual performance enhancers, such as Tribulus Terrestris (a fruit-bearing plant), Tongkat Ali (a type of shrub-like tree), and ginseng (a root).
Franklin Lowe, M.D., Vice Chairman of the Department of Urology at Montefiore Medical Center and a Professor at Albert Einstein School of Medicine, warned the public in an NBC News interview, saying, "Individuals should exercise considerable caution when considering the consumption of numerous products and supplements. Unfortunately, the lack of regulation means that most people remain uninformed about their contents."
Dr. Lowe further emphasized, "The information provided on the label does not always accurately reflect the true contents within the bottle or the pill. This case serves as a prime illustration of that discrepancy."
A Growing Danger
The FDA continues to issue alerts regarding the increasing number of contaminated sexual enhancement products. In April, nearly a dozen honey-based sexual supplements containing concealed drugs were flagged by the FDA. Moreover, in 2019, the FDA cautioned that sexual enhancement pills available online might secretly include ingredients such as sildenafil, the primary component of Viagra.
Dr. Jack Jeng, Chief Medical Officer at Hone Health, emphasizes the critical importance of men experiencing erectile dysfunction seeking medical advice. He explains, "Erectile dysfunction serves as a risk indicator for cardiovascular disease and may be attributed to underlying issues such as low testosterone. A physician can assess your medical history and conduct lab tests to establish the most suitable course of action. In cases where medication is deemed necessary, your doctor will issue a prescription and closely monitor its effectiveness and potential side effects."
Drugs often has side effects, such as Mounjaro.
