FDA warns about dietary supplements

March 26, 2008

The U.S. Food and Drug Administration has advised consumers not to use "Blue Steel" or "Hero" dietary supplements.

The FDA said it considers the supplements to be unapproved drugs that haven't been found safe or effective. The agency also said the products contain undeclared ingredients that might negatively affect a person's blood pressure.

Both products -- touted as "all natural" dietary supplements -- are promoted and sold over the Internet for the treatment of erectile dysfunction and for sexual enhancement. However, FDA officials said 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 erectile dysfunction.

Sildenafil might interact with nitrates found in some prescription drugs and can lower blood pressure to dangerous levels, the agency said.

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 are distributed by Active Nutraceuticals or the Marion Group of Carrollton, Ga.

Copyright 2008 by United Press International

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