The FDA has warned four companies allegedly selling tainted honey products that may be contaminated with hidden active drug ingredients. The four companies are Thirstyrun LLC, also known as US Royal Honey LLC; MKS Enterprise LLC; Shopaxx.com; and 1am USA Incorporated doing business as Pleasure Products USA. The FDA says these products can “post a significant health risk to consumers.”
Laboratory testing conducted by the FDA found that the product samples contained active drug ingredients that were not listed on the product labels. They were the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs that are restricted to use under the supervision of a licensed health care professional. Those ingredients can interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.
Judy McMeekin, Pharm. D., who is the FDA Associate Commissioner for Regulatory Affairs, said in a statement, “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. 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.”
The federal law was violated because the companies are selling active drug ingredients in product marketed as foods. Some of the products are represented as dietary supplements, even though tadalafil and sildenafil are excluded from the legal dietary supplement definition. The companies are also allegedly making unauthorized claims that their products treat disease or impure health. The products are sold on various websites and online marketplaces and may be sold in some retail stores.
If you have taken these supplements and had an adverse health reaction, see your doctor. You can then report it to the FDA’s MedWatch Adverse Event Reporting System.
