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Testing by the FDA found that products being sold throughout the East Coast could pose a significant health risk to consumers due to the presence of drug ingredients that can be found in Cialis (tadalafil) and Viagra (sildenafil).
Officials noted that those drugs are used to treat erectile dysfunction and are “restricted to use under the supervision of licensed health care professionals.
The undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels, according to the FDA.
Americans with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates are at the greatest risk of suffering side effects from the products, the agency noted.
The warning letters were issued to:
- Thirstyrun LLC (also known as US Royal Honey LLC);
- MKS Enterprise LLC;
- Shoppax.com;
- 1am USA Incorporated dba Pleasure Products USA.
Companies marketing food products containing tadalafil and/or sildenafil violate federal law, officials added.
Some of the products cited in the warning letters are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval, they continued.
“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,” FDA Associate Commissioner for Regulatory Affairs Judy McMeekin stated.
The warning letters “outline how companies violated federal law by selling active drug ingredients in products marketed as foods, like honey, and by making unauthorized claims that their products treat disease or improve health,” according to the FDA.
In some cases, the companies alleged that their products claim reference diseases that can only be diagnosed or treated under medical supervision.
Additionally, some products cited in the warning letters are represented as dietary supplements even though tadalafil and sildenafil products are excluded from the dietary supplement definition.
The tainted products are being promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores, officials noted.
“Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers,” McMeeken continued. “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.”
Moving forward, the companies in question will have up to 15 days to address how they will rectify the issue to the FDA or provide their reasoning for why they are not in violation of the law.
If they fail to do so, officials said the companies will result in potential legal action, product seizure, or an injunction.
The warnings come on the heels of the FDA previously warning customers about nearly a dozen similar honey-based products that contain hidden drug ingredients that were sold through Amazon, eBay, Walmart, and other retailers.
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