FDA Warns on "Blue Steel", "Hero" SupplementsMar 26, 2008 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) is warning consumers to not purchase or use both the “Blue Steel” and “Hero” products. Both of these products are being marketed as supplements for erectile dysfunction and sexual enhancement and are being labeled and marketed as dietary supplements throughout the United States. Blue Steel and Hero are considered unapproved drugs—the FDA is calling these products illegal drugs—they have not been proven to be safe or effective and, as a matter-of-fact, the FDA is saying that these illegal drugs pose serious health risks. Blue Steel and Hero products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level.
These products are promoted and sold over the Internet 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 which are similar in chemical structure to sildenafil, the active ingredient in Viagra. Viagra is an FDA-approved prescription drug for erectile dysfunction. "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, M.D., 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. Both products distributed by Active Nutraceuticals or the Marion Group, Carrollton, Georgia.
The undeclared ingredients in these products may interact with nitrates found in some prescription drugs, such as the heart medication nitroglycerin. These products can also lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and erectile dysfunction is a common problem in men with these medical conditions. Because men with these conditions may have been advised against taking medications for erectile dysfunction, they may seek products like Blue Steel and Hero because the products are marketed as "all natural" or as not containing the active ingredients in approved erectile dysfunction medications. FDA chemical analysis revealed that both Hero and Blue Steel contain substances similar in chemical structure to sildenafil; however, they are not components of an FDA approved drug. It’s important to note that these products’ labels do not list any of these substances.
The FDA is advising consumers who may have used Blue Steel or Hero to discontinue their use and consult their health care professional if they have experienced any adverse events which could be related to these products. Also, consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. The FDA recommends consumers speak with their health care professional about FDA‑approved treatments for erectile dysfunction; the FDA may take further regulatory actions to protect consumers from these illegal products.