Using Medicine to Improve Appearances : Cosmetics or Drugs? Side Effects

by Food and Drug Administration (FDA)

(Page 2 of 3)

Cosmetics or Drugs?

Much confusion exists about the status of cosmetic products having medicinal or drug-like benefits, says Linda Katz, M.D., M.P.H., director of the FDA's Office of Cosmetics and Colors. Although the FDA does not consider the term "cosmeceutical" to be a valid product class, Katz says it is used throughout the cosmetic industry to describe products that are marketed as cosmetics but that have drug-like effects. Tretinoin (retinoic acid), the biologically active form of vitamin A, for example, is not prohibited from use in cosmetics. However, when it is used topically for treating mild to moderate acne, sun-damaged skin, and other skin conditions, it is recognized by the FDA as a drug. This is because it acts deep at the skin's cellular level by increasing collagen.

According to the AAD, the answer to whether or not cosmeceuticals really work lies in the ingredients and how they interact with the biological mechanisms that occur in aging skin. The regulatory question the FDA faces when considering such products, Katz says, "is whether or not a manufacturer is making a structure or function claim."

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.

Some pharmaceutical companies, however, apparently aren't ready to enter the vanity drugs arena. Patrick Davish, the global product communications spokesman for Merck & Co. Inc., says that the drug company has no "cosmetic" drugs in its product pipeline at this time.

"The fact that we don't participate in that market right now-I'm not sure that's reflective of any particular deliberation or decision," he says. "That's just not where the science has taken us."

Saving Face

According to the American Society for Aesthetic Plastic Surgery (ASAPS), nearly 7 million Americans underwent surgical and nonsurgical cosmetic procedures in 2002. Laura Bradbard was one of them.

Despite the sudden explosion of such "lunchtime" techniques as Restylane for erasing wrinkles, and Botox (botulinum toxin type A) for smoothing out frown lines, Bradbard, of Gaithersburg, Md., opted for a longer-lasting reconstructive facelift that included a chin implant, eyelid surgery, and surprisingly, only a few days of pain-free recovery.

"None of this was medically necessary," admits Bradbard, a 48-year-old FDA press officer, "but I had been feeling worn out and tired. What I saw in the mirror was sad." Bradbard says she didn't get a facelift to look younger; she only wanted her face to look more balanced. In the end, she says, "My doctor gave me a chin that geometrically fit my face," and a look that she says makes her feel better about herself.

Like Bradbard, others are spending a lot of money to look good. "With patients living 90-plus years, today's anti-aging modalities offer people noninvasive procedures that mimic true facelifts," says Craig R. Dufresne, M.D., a plastic and reconstructive surgeon in Chevy Chase, Md., who performed Bradbard's surgery. However, Dufresne says he suggested reconstructive surgery for Bradbard because "she wanted to deal with structural changes to restore facial balance," which was more than the chemical action of a drug could produce. "And skin product application (such as wrinkle fillers) following a facelift," adds Dufresne, "will actually allow the facelift or any other reconstructive procedure to last longer and make a great result even better."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.