The FDA uses different standards when evaluating the risks and benefits of products used for cosmetic treatments than for therapeutic uses of products. Steven K. Galson, M.D., M.P.H., acting director for the FDA's Center for Drug Evaluation and Research, adds that products like tretinoin and Restylane that are not indicated for serious or life-threatening conditions are subject to close examination by the agency because of the benefit-to-risk ratio.

"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).

"There's a lot of serendipity in drug development," says the FDA's Wilkin. A pill to help smokers quit, for example, evolved out of the unexpected observation that a drug intended to treat depression also seemed to take away the desire to smoke. Bupropion was first marketed in 1989 by GlaxoSmithKline as an antidepressant under the name Wellbutrin. After doctors noticed that patients being treated with Wellbutrin gave up smoking spontaneously, studies were done to show that the product could help smokers quit, as well. As a result, the slow-release form of bupropion, marketed as Zyban, was approved by the FDA in 1997 as an aid to smoking cessation treatment.