Honey-based sexual supplements may contain Cialis and Viagra ingredients, FDA warns
The Food and Drug Administration (FDA) has recently taken a significant step by issuing warning letters to four companies that are engaged in the sale of honey-based supplements marketed for sexual enhancement. These products have alluring names, such as "Royal Honey for Him" and "X Rated Honey for Men," but the FDA has raised serious concerns about their safety, stating that they may contain undisclosed pharmaceuticals.
According to the FDA, their own laboratory testing has revealed the presence of tadalafil and sildenafil in these honey products—active components that are also found in the well-known prescription medications Cialis and Viagra, used for treating erectile dysfunction. Alarmingly, these ingredients were not disclosed on the product labels, leading to potential safety and health risks for consumers who may unknowingly ingest these substances.
In a formal statement released on July 12, the FDA disclosed that the inclusion of such pharmaceuticals in these supplements poses a serious health risk to consumers, particularly for individuals who may be taking nitrates. This is especially pertinent for patients suffering from conditions like diabetes, high cholesterol, or heart disease, where an interaction with these drugs could cause a perilous drop in blood pressure. Furthermore, it is crucial to note that other consumers might also experience allergic reactions or sensitivities to these undisclosed medications.
The FDA emphasized that the unapproved addition of a drug into a food product intended for interstate commerce is a violation of federal law. The agency has mandated that the companies in question have a period of 15 days to either outline the steps they will take to rectify the situation or to justify their belief that their products comply with legal standards. Failure to respond adequately may result in serious consequences, including seizure of products, injunctions, or referral to the FDA’s Office of Criminal Investigations, as noted by an agency spokesperson.
The specific companies that have received these warning letters from the FDA include Thirsty Run LLC, also known as US Royal Honey LLC, 1am USA Incorporated doing business as Pleasure Products USA, Shopaax.com, and MKS Enterprise LLC. Notably, two of these companies have not responded to inquiries for comments. However, Shopaax.com did reference a recall notice for its product, “Kingdom Honey Royal Honey VIP,” while MKS Enterprise announced its intention to recall another product, “Dose Vital VIP Vital Honey.”
Additional products highlighted in the FDA's warnings encompass "Vital Honey for Men" and "Secret Miracle Royal Honey for Her." As stated by the FDA, these items are often available for purchase online and may also be found in certain retail stores.
These supplements typically make grand claims regarding their ability to enhance sexual performance and improve reproductive health. For instance, the product description for “Royal Honey for Men” touts it as being derived from "the most potent and natural source of sexual power and testosterone—Royal Honey" enriched with a mix of rich floral nectar and selected roots aimed at maximizing its effects. The ingredient list includes ginseng root and tribulus terrestris, a plant known for its potential health benefits.
Dr. Franklin Lowe, who serves as the vice chairman of the Department of Urology at Montefiore Medical Center and is also a professor at the Albert Einstein School of Medicine, issued a cautionary statement urging consumers to exercise extreme caution when considering the use of such supplements. He noted the unregulated nature of these products and emphasized that consumers often remain unaware of their actual contents. "What is included on the label does not necessarily correlate with what is truly in the bottle or the pill," he stated, highlighting the discrepancy.
Because dietary supplements are categorized and regulated as food products rather than pharmaceuticals, the FDA does not conduct safety assessments, effectiveness evaluations, or labeling verifications, and these products do not receive federal approval before hitting the market. It is worth mentioning that other sexual enhancement supplements have similarly been found to contain hidden active drug ingredients in prior instances.
The FDA has previously issued consumer warnings, specifically in April, regarding numerous other honey-based sexual supplements that were discovered to harbor drug ingredients. In 2019, an alert was raised concerning sexual enhancement pills sold through various online retailers, including Amazon, which contained undisclosed and potentially harmful ingredients like sildenafil.
In light of this ongoing issue, an FDA spokesperson stated that alerts about tainted sexual enhancement supplements have been an ongoing endeavor since at least 2007, with the first alert concerning honey-based products occurring back in 2017.
Elliot Lewis
Elliot Lewis is an intern for NBC News.