FDA Cracks Down on Honey-Based Products Tainted With Undeclared Drugs

Warning letters have been issued by the Food and Drug Administration (FDA) to 4 companies illegally selling honey-based products containing undeclared ingredients, including active drug ingredients such as tadalafil and sildenafil.

According to the FDA, 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 Companies are in violation of the Federal Food, Drug, and Cosmetic Act, as products marketed as foods, like honey, were being marketed with unauthorized claims to treat a disease or improve health.

The products were being promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores. The letters also cited that certain products were represented as dietary supplements, even though the presence of tadalafil and sildenafil excludes them from the dietary supplement definition.

Sildenafil and tadalafil are both phosphodiesterase type 5 inhibitors. These drugs may potentiate the hypotensive effects of nitrates; administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is contraindicated. Additionally, these drugs can potentiate the hypotensive effects of alpha blockers and antihypertensive medications.

“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, PharmD, “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.”

Reference

FDA warns four companies for selling tainted honey-based products with hidden active drug ingredients. News release. US Food and Drug Administration. Accessed July 12, 2022. https://www.fda.gov/news-events/press-announcements/fda-warns-four-companies-selling-tainted-honey-based-products-hidden-active-drug-ingredients