On July 12, the FDA announced that it issued warning letters to four companies for illegally selling honey-based products that could pose a significant health risk to consumers due to the presence of active drug ingredients not listed on the product labels. The FDA’s laboratory testing found that product samples contained 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 and both 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.

It is a violation of federal law to market food products containing tadalafil and/or sildenafil. The warning letters cited that some of the products are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and lack FDA approval. Additionally, some of the products are represented as dietary supplements even though tadalafil and sildenafil are excluded from the dietary supplement definition.

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. 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.

As recently as April 2022, the FDA had previously warned consumers about more than 10 honey-based products that contained hidden drug ingredients, like tadalafil and sildenafil. In December of 2020, the FDA also warned consumers to avoid products with hidden drug ingredients sold through Amazon, eBay, Walmart, and other retailers. As noted in the press release, the FDA has stated that the Agency 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.”