The U.S. Food and Drug Administration has warned four companies for illegally selling honey-based products with hidden active drug ingredients, including tadalafil and sildenafil.
The warning letters were issued to Thirstyrun LLC, also known as US Royal Honey LLC; MKS Enterprise LLC; Shopaax.com; and 1am USA Incorporated dba Pleasure Products USA. Their products are promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.
According to the agency, the companies violated federal law by selling active drug ingredients in products marketed as foods, like honey. They also made unauthorized claims that their products treat disease or improve health.
The FDA in a laboratory testing found that the product samples contained active drug ingredients such as Cialis (tadalafil) and Viagra (sildenafil), which are not listed on the product labels. Cialis and Viagra are FDA approved drugs used to treat men with erectile dysfunction. Sildenafil and tadalafil are restricted to use under the supervision of a licensed health care professional.
Further, some of the products cited in the warning letters are also unapproved new drugs as they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval.
The FDA noted that these undeclared ingredients are likely to interact with nitrates found in some prescription drugs, such as nitroglycerin, and would lower blood pressure to dangerous levels.
People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
The agency urged consumers to remain vigilant when shopping online or in stores, and to seek effective, FDA-approved treatments.
The FDA has requested responses from the companies within 15 working days about their plans to address these issues. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
The FDA has previously warned consumers about more than 10 honey-based products containing hidden drug ingredients, including sildenafil and tadalafil, sold through Amazon, eBay, Walmart and other retailers.
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