After the Food and Drug Administration (FDA) discovered erectile dysfunction drugs in multiple honey products, Sopaax.com and MKS Enterprise LLC are both voluntarily recalling certain honey products. The FDA found via lab testing that the products contained undisclosed Viagra and Cialis, FDA-approved drugs used to treat erectile dysfunction, and sent both companies warning letters.
Shopaax.com on July 13 voluntarily recalled its Kingdom Honey Royal Honey VIP, per a notice posted by the FDA. The recalled product, sold in a golden box, containing 12 sachets of 20 grams of honey with different expiration dates stamped on the back side, was promoted and sold for sexual enhancement on various websites. The company stopped selling the product online and temporarily removed all other products on the website pending investigation after FDA testing found the product contains Sildenafil, the active ingredient in the FDA-approved prescription drug Viagra.
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Just days later, MKS Enterprise LLC on Monday recalled its Dose Vital VIP Vital Honey product for the same reason. The product comes in a black box and contains 12 sachets of 15 grams of honey with different expiration dates stamped on the back side. Per a recall notice, the recall was initiated after FDA laboratory analysis confirmed that the product contains the undeclared active pharmaceutical ingredient Tadalafil.
The recalls were issued shortly after the FDA in a July 12 release said it issued warning letters to four companies selling honey-based supplements that claim to provide sexual enhancement. The agency explained that its internal lab testing found Tadalafil and Sildenafil in the honey products, ingredients that were not listed on the label and are “only available by prescription.”
“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,” FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D., said in the release. “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 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 and outlined how the companies “violated federal law by selling active drug ingredients in products marketed as foods, like honey, and by making unauthorized claims that their products treat disease or improve health.” Although both Tadalafil and Sildenafilare FDA-approved drugs, they “are restricted to use under the supervision of a licensed health care professional.” They pose potentially serious health risks to some, as the drugs may interact with nitrates found in some prescription drugs, possibly lowering blood pressure to dangerous levels, the FDA said.
