FDA warns consumers about unapproved E.D. products

ROCKVILLE, Md. The Food and Drug Administration on Tuesday advised consumers not to purchase or use “Blue Steel” or “Hero” products marketed as dietary supplements throughout the United States because they are considered unapproved drugs and have not been proven to be safe or effective. Both products are distributed by Active Nutraceuticals or the Marion Group.

The Blue Steel and Hero products are promoted and sold over the Internet for the treatment of erectile dysfunction and for sexual enhancement, the FDA stated. They’re touted 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 E.D.

“Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” stated Janet Woodcock, director of 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.”

Blue Steel is sold in bottles containing 10 blue capsules or blister packs containing two blue capsules. Hero is sold in blister packs containing two blue capsules.