The FDA is advising consumers not to purchase or use Blue Steel or Hero products marketed as dietary supplements throughout the U.S. because they are considered unapproved drugs and have not been proven to be safe or effective, and could dangerously affect a person’s blood pressure level.
The agency said that the products are promoted and sold over the internet for the treatment of erectile dysfunction (ED) and for sexual enhancement, and are advertised as all natural and labeled as dietary supplements.
However, Blue Steel and Hero products do not qualify as dietary supplements because they contain undeclared and unapproved substances that are similar in chemical structure to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED, according to the agency.
“Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking.”
The FDA said that undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and could lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates, the FDA said. FDA chemical analysis revealed that both Hero and Blue Steel contain substances that are similar in chemical structure to sildenafil; however, they are not components of an FDA approved drug. Additionally, the products’ labels do not list any of the substances.