Honey Laced With Erectile Treatment By NJ Company Violates Law: FDA

CLIFTON, NJ — You can catch more flies with honey than vinegar, but sometimes the sweet substance will also help you catch an unapproved method for treating erectile dysfunction and other ailments. Federal regulators sent a warning July 1 to a New Jersey-based company that sells "Vital Honey," which contains the active ingredient found in Cialis, according to the U.S. Food and Drug Administration.

Cialis is a federally approved treatment, but the use of the active ingredient tadalafil must come under the supervision of a licensed health care professional, according to the agency. The Passaic County-based MKS Enterprise LLC sells a product online called Dose Vital Royal Honey VIP Honey — or, Vital Honey — which contains tadalafil, according to federal regulators.

Companies marketing food products containing the drug violate federal law, according to the FDA. Additionally, the website claims that Vital Honey has several medical benefits, including lower cholesterol, decreases of prostate issues and prevention of arthritis and multiple sclerosis, the agency's letter states.

Federal health regulators haven't recognized Vital Honey as a safe and effective treatment for any of the listed ailments. Therefore, the FDA classifies the product as a "new drug," which means the agency must approve it for the market based on scientific data.

Patch contacted the email address listed on MKS Enterprise's website but has not yet received a response.

The company selling Vital Honey describes itself as a "small online retailer" on its website — wholesaleonline1.com. MKS Enterprise doesn't manufacture any products and doesn't have a physical store location, but the company says it's based in Clifton.

Products on the website include "male enhancement pills" with "real honey," according to the listing. But the FDA says the website's Vital Honey products violate federal law and can have dangerous consequences.

Tadalafil can interact with nitrates found in prescription drugs, such as nitroglycerin, and may lower blood pressure to "dangerous levels," according to the FDA. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates, the agency says.

"Your product Vital Honey is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner," the FDA's warning letter says. "Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes."

The FDA gave the company 15 business days within receipt of the letter to provide the agency with a written plan to prevent recurring violations. Failure to do so may result in legal action, including seizure and injunction.