The U.S. Food and Drug Administration (FDA) has sent warning letters to four companies that the agency said are illegally selling honey-based products that may pose a significant health risk to consumers.
The warning letters were sent to Thirstyrun LLC, also known as US Royal Honey LLC; MKS Enterprise LLC; Shopaax.com; and 1am USA Incorporated, dba Pleasure Products USA.
The FDA said its laboratory found that samples of products from the four companies contained active drug ingredients that were not listed on the product labels, including the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA-approved drugs used to treat men with erectile dysfunction.
Potentially dangerous interactions
Sildenafil and tadalafil are prescription drugs, so they can not be used unless they're provided by a licensed health care professional. The agency said the potential risks are significant.
For example, it says the undeclared ingredients 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.
"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," said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin.
McMeekin says unidentified ingredients are not only dangerous, but they may prove to be deadly in some cases.
“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," she said.
The warning letters informed the companies it is a violation of federal law to market a product as food when it also contains active drug ingredients. According to the FDA, the companies were likely aware of their products’ drug-like properties because they are being marketed for “sexual enhancement” on various websites, online marketplaces, and possibly in some retail stores.
The FDA has ordered the four companies to respond to the letter within 15 days and present evidence to show that the products do not violate U.S. law.