Four companies selling honey-based products containing unlisted active drug ingredients have received warning letters from the U.S. Food and Drug Administration (FDA). The companies promoted these products as sexual enhancers, and laboratory testing revealed that they contained active ingredients found in drugs for erectile dysfunction — namely, tadalafil (Cialis) and sildenafil (Viagra), the FDA announced (opens in new tab) Tuesday (July 12).
Tadalafil and sildenafil may be used only under the supervision of a licensed health care professional, in part because they interact with common prescription medications known as nitrates. Nitrates are commonly taken by people with diabetes, high blood pressure, high cholesterol and heart disease and work by causing blood vessels to dilate, thus increasing the flow of blood and oxygen to the heart, according to the medical database StatPearls (opens in new tab).
Tadalafil and sildenafil also cause blood vessels to dilate, so if someone takes these drugs at the same time as nitrates, their blood pressure may plummet to dangerously low levels. Severely low blood pressure can be life-threatening because vital organs may not receive an adequate supply of blood and oxygen, and this deficit can lead to shock, irreversible organ damage and death, according to the Mayo Clinic (opens in new tab).
"Tainted 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," Judy McMeekin, the FDA's associate commissioner for regulatory affairs, said in the agency's statement.
Related: Men who took erectile-dysfunction drug had blue-tinted vision for days
"Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers," she said. "We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that put their health at risk, and instead seek effective, FDA-approved treatments."
The four companies that received warning letters include Thirstyrun LLC (also known as U.S. Royal Honey LLC), MKS Enterprise LLC, Shopaax.com, and 1am USA Incorporated dba Pleasure Products USA. The FDA said these companies violated federal law by allegedly selling active drug ingredients in products marketed as foods and by making unauthorized claims that their products treat disease or improve health.
Specifically, the products — including Etumax VIP Royal Honey for Him, Dose Vital Honey for Men, Secret Miracle Royal Honey for Her and X-Rated Honey for Men — were promoted as sexual enhancement products.
"The FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law," the FDA statement reads. "Failure to promptly address the violations may result in legal action, including product seizure and/or injunction."
The FDA encourages consumers to speak with a health care provider before trying any over-the-counter product marketed for sexual enhancement. Consumers can also refer to the FDA's health fraud products database (opens in new tab) to check if a product has been flagged as potentially hazardous.
Consumers and health care providers can report adverse reactions related to specific products through the FDA's MedWatch (opens in new tab) program or the Safety Reporting Portal (opens in new tab).
Originally published on Live Science.
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[06-15-2021] Update: FDA attempted several times to contact ahmedjamilmuslim to discuss how the company can protect consumers from these dangerous products. This product was sold by ahmedjamilmuslim via eBay. See FDA’s press release for additional information.
[12-17-2020] The Food and Drug Administration is advising consumers not to purchase or use Royal Honey, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.
FDA laboratory analysis confirmed that Royal Honey purchased from eBay.com contains tadalafil, the active ingredient in Cialis, an FDA-approved prescription drug for erectile dysfunction. FDA approval of Cialis is restricted to use under the supervision of a licensed health care professional. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
Please refer to the links below for more information:
Tainted Sexual Enhancement Products
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Beware of Fraudulent ‘Dietary Supplements’
The Food and Drug Administration is advising consumers not to purchase or use Royal Honey, a product promoted and sold for sexual enhancement on various websites, including eBay.com, and possibly in some retail stores.
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