The four warning letters were made public last week. They were sent to Thirstyrun LLC (also known as US Royal Honey LLC), MKS Enterprise LLC, Shopaax.com, 1am USA Incorporated dba Pleasure Products USA.
Honey as an aphrodisiac
The companies ostensibly were trading on the history of use of honey as an aphrodisiac. Honey is one of the oldest foods harvested by humans, with depictions of honey gathering found in Spanish cave paintings dated to about 8,000 years ago.
The health properties associated with honey go back almost as far. The complex combination of sugars and other constituents has noted antimicrobial properties. It has been used in wound care for centuries.
The ingredient has also been purported to be an aphrodisiac. It has been associated with fertility since Biblical times, with quotations alluding to the ‘land of milk and honey.’
Unlike some of honey’s other health properties, these assertions find no backing in modern nutrition research, however. According to the FDA warning letters, whatever sexual enhancement properties of the honey products might have is entirely due to the inclusion of undeclared pharmaceutical ingredients found in Cialis (tadalafil) and Viagra (sildenafil).
Dangers of hidden APIs with undeclared dosages
These ED drugs are contraindicated for men with high blood pressure, advanced cardiovascular disease and/or who are at a heightened risk of stroke. According to FDA, the danger posed by these products is not only in the hidden nature of the APIs, but in the complete lack of dosing information.
“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.”
In addition to the four warning letters made public last week, FDA updated a standing warning to consumers about other tainted products found in the market. That warning summed up the results of the most recent testing on an additional 15 products (beyond those mentioned the warning letters) done in 2022. Of the 15 products tested in 2022, five had ‘honey’ in their names.