Executive Summary

In its latest warning on adulterated supplements sold as treatments for erectile dysfunction, FDA advises consumers not to use Blue Steel or Hero products distributed by Active Nutraceuticals because they are considered unapproved drugs and have not been proven to be safe or effective. The products contain undeclared and unapproved substances similar in chemical structure to sildenafil (Pfizer's Viagra), FDA says. "Because these products are labeled as 'all natural dietary supplements,' consumers may assume that they are harmless and pose no health risk," but the sildenafil may interact with nitrates found in some prescription drugs and can lower blood pressure to dangerous levels, the agency says (1"The Tan Sheet" Jan. 28, 2008, p. 11). Active, a unit of Carrollton, Ga.-based Marion Group, distributes Blue Steel in 10-count bottles or in blister packs and Hero in two-capsule blister packs...