The court order alleges the defendants violated the FD&C Act by selling unapproved and misbranded drugs to U.S. consumers using more than 100 websites. According to the complaint, the label on the defendants’ products claimed—without FDA approval or clinical studies demonstrating safety and effectiveness—that the products could treat or prevent a variety of serious conditions, including erectile dysfunction, impotence and prostatitis (swelling and inflammation of the prostate gland). The complaint also stated the products were misbranded because they did not include adequate directions for use and their labels omitted material information.
FDA laboratory testing found some of the products contained undisclosed sildenafil, which is the active pharmaceutical ingredient in the prescription drug Viagra. The use of sildenafil, particularly when its presence is hidden from consumers, can pose serious health risks to patients with underlying medical issues, such as heart disease and high blood pressure.
"Despite our warning, the defendants refused to comply with the law, and they put consumers at serious risk," said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "Particularly egregious is the undisclosed presence of sildenafil, a potentially dangerous active pharmaceutical ingredient that requires a doctor’s prescription. We will continue to take aggressive action when we learn of unsafe products and dishonest marketing."
The FDA issued a warning letter to the companies after the agency conducted laboratory analysis that revealed the presence of an undeclared pharmaceutical ingredient in several products.
The U.S. Department of Justice filed the complaint on behalf of the FDA.