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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
March 25, 2008

Media Inquiries:
Stephanie Kwisnek, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Warns Consumers Not to Use "Blue Steel" and "Hero" Products
Products are illegal drugs and pose serious health risks

The U.S. Food and Drug Administration is advising 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. These products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level.

These products are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. 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 ED.

"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."

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, these men 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 ED drugs.

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’ label do not list any of these substances.

The FDA advises consumers who have used either of these products to discontinue use and consult their health care professional if they have experienced any adverse events that they feel are related to the use of these products. 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 that consumers should talk to 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.

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, Ga.

For more information, visit: http://www.fda.gov/consumer/updates/erectiledysfunction010408.html

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