In this case, the companies are selling honey-based products and marketing them with claims that they improve health. Instead, they contain hidden prescription drugs.
“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., in a Tuesday press release.
The prescription drugs connected to the latest warning, tadalafil and sildenafil, are the active drug ingredients found in Cialis and Viagra. Both are FDA-approved drugs to treat men with erectile dysfunction but are restricted to use under the supervision of licensed health care professionals.
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
The FDA said it is finding an increasing number of illegally-marketed, adulterated honey-based or honey-flavored syrup products that test positive for active drug ingredients not listed on the label. This causes issues for people on medication for diabetes, high blood pressure, high cholesterol, or heart disease.
“Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers,” said McMeekin. “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.”
The products were promoted and sold for sexual enhancement on various websites, marketplaces, and possibly in some stores.
The FDA is also concerned that because the companies label their products as dietary supplements and sell them illegally, they are not subject to the same approval process and quality standards as medicine from the doctor. This means some products could contain only a small percentage of a normal prescription dose, while others contain multiple times the typical dose.
“If you are struggling with sexual performance issues, you may have a physical condition that is keeping your body from responding as it normally would,” the FDA said in a consumer alert. “Talk openly with your health care professional before considering any treatments.”
The FDA wants to know how they will address the issue or provide their reasoning and supporting information as to why they think the products are not in violation of the law. If they don’t, they face legal action, including product seizure and/or injunction. The companies were given 15 days to respond.