- For immediate release:
Today, the United States Food and Drug Administration (FDA) issued warning letters to four companies for illegally selling honey products that may pose a significant health risk to consumers. FDA lab tests found product samples to contain active drug ingredients not listed on 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 limited to use under the supervision of a licensed healthcare professional. These undeclared ingredients can interact with nitrates found in some prescription medications, such as nitroglycerin, and can lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
“Contaminated honey products like these are dangerous because consumers are likely unaware of the risks associated with the hidden ingredients of prescription drugs in these products and how they may interact with other drugs and supplements they can take,” the FDA’s associate commissioner for regulatory affairs said. Judy McMeekin, Pharm.D., “Products marketed with unidentified ingredients can be dangerous and, in some cases, fatal to consumers. We encourage consumers to remain vigilant when shopping online or in-store to avoid purchasing products that put their health at risk, and instead seek out effective, FDA-approved treatments.
Today’s warning letters describe how the companies violated federal law by selling active drug ingredients in products marketed as food, such as honey, and making unauthorized claims that their products treat diseases 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 sent to:
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 are not FDA approved. In some cases, product claims refer to conditions that can only be diagnosed or treated under medical supervision. Additionally, some products cited in the warning letters are depicted as dietary supplements even though tadalafil and sildenafil products are excluded from the definition of dietary supplements.
The FDA has requested responses from the companies within 15 business days indicating how they will address these issues or providing their reasoning and supporting information as to why they believe the products are not in violation of the law. Failure to promptly remedy violations may result in legal action, including seizure of the product and/or an injunction.
Consumers using or considering using any over-the-counter product marketed for sexual enhancement should first consult a healthcare practitioner, 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 has previously warned consumers about more than 10 honey products containing hidden medicinal ingredients. FDA lab tests found product samples to contain undeclared active ingredients, including sildenafil and tadalafil. The agency also previously warned consumers to avoid products with hidden medicinal 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 is urging stores, websites and online marketplaces to stop selling these products.
If a consumer believes a product may have caused a reaction or 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 Security Report Portal.
The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.