WASHINGTON, DC (WXIN) — The FDA is issuing a warning to four companies selling products that are more successful than their marketing materials suggest.
In this case, companies sell honey products and market them claiming to improve health. Instead, they contain hidden prescription drugs.
“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 can interact with other drugs and supplements they can take,” the FDA’s associate commissioner for regulatory affairs said. Judy McMeekin, Pharm.D., in a press release Tuesday.
The prescription drugs linked to the latest warning, tadalafil and sildenafil, are the active medicinal ingredients found in Cialis and Viagra. Both are FDA-approved drugs to treat men with erectile dysfunction, but their use is limited under the supervision of licensed medical professionals.
The warning letters were sent to:
The FDA said it was discovering a growing number of illegally marketed honey-based or honey-flavored syrups that tested positive for active drug ingredients not listed on the label. This causes problems for people taking medication for diabetes, high blood pressure, high cholesterol, or heart disease.
“Products marketed with unidentified ingredients can be dangerous and, in some cases, fatal to consumers,” McMeekin said. “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 out effective, FDA-approved treatments.”
The products were promoted and sold for sexual enhancement on various websites, marketplaces and eventually in some stores.
The FDA is also concerned that because companies label their products as dietary supplements and sell them illegally, they may not go through the same approval process and quality standards as doctor’s drugs. This means that some products may only contain a small percentage of a normal prescription dose, while others contain many times the typical dose.
“If you are struggling with sexual performance issues, you may have a physical condition that prevents your body from responding as it normally would,” the FDA said in a consumer alert. “Talk openly with your healthcare professional before considering any treatment.”
The FDA wants to know how it will address the issue or provide its reasoning and supporting information as to why it believes the products are not in violation of the law. Failure to do so may result in legal action, including seizure of the product and/or an injunction. Companies had 15 days to respond.