"Because these products are for cosmetic purposes, they must be extraordinarily safe," Galson says. This means that the FDA may allow someone to incur a greater risk from products that treat medical conditions, rather than from those that are intended for cosmetic purposes. "We generally won't tolerate much risk for a drug whose primary use is cosmetic," he says.

Welcome Side Effects
Many cosmetic treatments are the result of common disease therapies whose unexpected side effects were pleasant surprises. Vaniqa (eflornithine hydrochloride), the first prescription drug for removing unwanted hair, is a topically applied version of a drug that was originally developed to treat African sleeping sickness. Similarly, minoxidil originally had been prescribed as an oral tablet to treat high blood pressure. As a result of side effects that included hair growth and reversal of male baldness, Rogaine (2 percent minoxidil) was the first drug approved by the FDA for the treatment of hair loss (androgenetic alopecia).