FDA Warns Against Vigor-25
FDA lawyers state Vigor-25, a product marketed as a dietary supplement to enhance male sexual performance, should not be consumed because it contains sildenafil, the active ingredient in the prescription drug Viagra.
Sildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and can dangerously lower blood pressure. The FDA is investigating the reported death of a 26-year old man, possibly associated with the use of Vigor-25.Aï¿½
Vigor-25, distributed by Piston Corp., is sold on Internet sites and possibly in some retail outlets.
“This product is dangerous to consumers because it claims to contain only natural ingredients when it actually contains a prescription drug ingredient,” said Deborah M. Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Tainted products place consumers at risk of injury and death, especially those consumers with underlying health conditions.”
FDA dietary supplement laws do not permit the use of pharmaceutical ingredients in a dietary supplement. FDA regulated dietary supplements which contain pharmaceuticals are considered adulterated and misbranded by FDA laws and require a new drug application to be allowed on the market. According to FDA laws, dietary supplements are only allowed to contain ingredients which are generally recognized as safe for use in a food or those which were in the food supply prior to 1994.
FDA lawyers have found products marketed as dietary supplements that contain active ingredients in FDA-approved drugs or variations of these ingredients.Aï¿½As a result, FDA is advising customers to stop using any sexual enhancement products who have experienced side effects.
Ms. Capote represents businesses with regulatory compliance issues and litigation. She focuses her practice on representing clients before regulatory agencies, such as the Consumer Product Safety Commission, Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Customs and Border Protection (CBP) and United States Department of Agriculture (USDA).