The FDA hit Bensenville, Illinois-based Empire Distributors with a warning letter for selling an unapproved new drug product containing the active ingredients for FDA-approved erectile dysfunction drugs.
The FDA ran a laboratory analysis of the company’s Rhino Black 5K Plus, marketed on the firm’s website and Amazon as a dietary supplement with claims of “immediate energy” and “increased stamina” on its labeling, among others. The testing confirmed that the product contained undeclared sildenafil and tadalafil, the active ingredients in Viagra and Cialis, respectively, making the product an unapproved new drug.
The agency flagged the potential for serious health risks or dangerous interactions with other drugs. It warned that the undeclared ingredients could interact with nitrates contained in some prescription drugs, such as nitroglycerin, and could lower blood pressure to dangerous levels. The agency said the product poses a greater risk for men with diabetes, high cholesterol, high blood pressure and heart disease, as they frequently take nitrates.