The FDA has sent warning letters to four US based companies selling honey which purported to improve sexual performance.
Laboratory tests determined that the product contain small amounts of sildenafil (the ingredient in Viagra) and tadalafil (the generic form of Cialis). The manufacturers did not disclose the fact that the medications were contained in the products.
Use of sildenafil and tadalafil, which belong to a class of drugs called PDE5 inhibitors, can pose serious health risks for men with certain heart conditions, or men taking prescription drugs containing nitrates. The drugs can cause a serious drop in blood pressure. This is why PDE5 inhibitors require a doctor’s prescription in the United States.
The FDA issues the letter on July 12, 2022, and gave the companies 15 days to respond. Failure to address the issue may result in fines or seizure of products.
The companies found to be in violation are:
- Thirstyrun LLC (also known as US Royal Honey LLC).
- MKS Enterprise LLC.
- 1am USA Incorporated dba Pleasure Products USA
According to the FDA letter, “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.”
Products containing undisclosed medical ingredients are a continuing problem.
In February, the FDA released an advisory that several herbal supplements sold on Amazon were tainted with tadalafil and sildenafil, which are phosphodiesterase type 5 (PDE5) inhibitors.
Product identified include Red Mammoth pills from Celebrate Today (Brentwood, New York), Red Pill capsules from our Favorite Shop (Jackson, New Jersey), and several products from Positive-Health (Wilmington, Delaware). The agency announced that the manufacturers are conducting voluntary recalls of their products.