On Tuesday, the U.S. Food and Drug Administration (FDA) issued warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers.
The FDA’s laboratory testing found that product samples contained active drug ingredients 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.
Sildenafil and tadalafil are restricted to use under the supervision of a licensed health care professional. These 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, Pharm.D., “Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers. 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.”
Tuesday’s 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. These products are promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.
The warning letters were issued to:
- Thirstyrun LLC (also known as US Royal Honey LLC),
- MKS Enterprise LLC,
- 1am USA Incorporated dba Pleasure Products USA
Companies marketing food products containing tadalafil and/or sildenafil violate federal law. 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. In some cases, product claims 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 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. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
Consumers using or considering using any over-the-counter product marketed for sexual enhancement should talk to a health care professional first, as some ingredients may interact with medications or dietary supplements. The FDA’s health fraud products database can help consumers identify nearly 1,000 of these potentially dangerous products.
The FDA previously warned consumers about more than 10 honey-based products containing hidden drug ingredients. The FDA’s laboratory testing found that product samples contained undeclared active ingredients, including sildenafil and tadalafil. The agency also previously warned consumers to avoid products with hidden drug ingredients sold through Amazon, eBay, Walmart and other retailers. The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market and urges stores, websites, and online marketplaces to stop selling these products.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.