Http:// FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA A smaller nose. Bigger breasts. Slimmer thighs. Plumper lips. Less hair on the body. Morehair on the head. Whether we're looking to tighten our tummies or lighten our laugh lines, America's fascination with youth and beauty has long fueled the development of medical products for cosmetic purposes. And if such "vanity drugs" can be shown to be safe and effective, the Food and Drug Administration just may approve.
The ongoing fight to delay or reverse the aging process has dermatologists and cosmetic plastic surgeons responding with products like Restylane (hyaluronic acid), one of a handful of soft tissue fillers recently approved by the FDA to treat facial wrinkles. Restylane is an injectable gel that acts as a filler to remove the wrinkle, producing instantaneous results. Such products are not as invasive as facelifts, eyelid surgery, and other reconstructive procedures. And they are more effective and last longer than creams,lotions and other topical products, whether over-the-counter or prescription. In addition, the fact that the treatments result in little or no downtime makes them more attractive to those seeking a quick fix. Without making a single incision, doctors can erase wrinkles, acne scars and sun damage in a matter of minutes.
"This is a huge industry," says Jonathan K. Wilkin, M.D., a medical officer in the FDA's Division of Dermatologic and Dental Drug Products. "The way people try to move the clock back is through the skin." Basically, he says, through various products and procedures, "they are addressing the effects of gravity on the skin over time." Aging Skin 101An increased understanding of the structure and function of the skin is helping to drive thedevelopment of products that reduce the visible signs of facial aging, according to the American Academy of Dermatology (AAD).
With aging, all skin cells begin to produce excess amounts of free radicals--unstableoxygen molecules that, under ideal circumstances, are removed by naturally occurringantioxidants within the skin's cells. In aging skin cells, antioxidants are in short supply.
The free radicals generated are left unchecked and cause damage to cell membranes,proteins, and DNA. These free radicals eventually break down a protein substance inconnective tissue (collagen) and release chemicals that cause inflammation in the skin. Itis a combination of these cellular and molecular events that leads to skin aging and theformation of wrinkles, the AAD says. As we get older, two components of our skin--collagen and elastin--degenerate, setting the stage for theappearance of wrinkles, creases, folds, and furrows. Thebreakdown of these components, accelerated by sun exposure and gravity, results in the sagging skin of oldage.
Illustration by Renée Gordon. Source: National Institute on Aging.
Considerable research has been done to understand the aging process, and studies now show that products containing bioactive ingredients (those that interact with living tissues or systems) can benefit sun-damaged, discolored, and aging skin, giving consumers new choices for restoring their overall appearance. But why is the FDA reviewing products that simply make people look and feel good when typically the agency evaluates disease-fighting treatments? "If something that is being implanted into the body could have health consequences, we'reconcerned about it," says Stephen P. Rhodes, M.S., chief of the FDA's Plastic and Reconstructive Surgery Devices Branch. "Wrinkle fillers affect the structure of the face and could have such health consequences." Facing FactsUnder the Federal Food, Drug and Cosmetic Act, the FDA legally defines products by their intended uses. Drugs are defined as products intended for treating or preventing disease and affecting the structure or any function of the body. A medical device is a product that also is intended to affect the structure or function of the body, but which does not achieve its primary intended purposes through the chemical action of a drug--nor is it dependent on being metabolized.
The hyaluronic acid in Restylane, although biosynthetically produced (formed of chemical compounds by the enzyme action of living organisms), is almost identical to that in all living organisms. Hyaluronic acid is a structural component of skin that creates volume and shape. Concentrations of hyaluronic acid throughout the body decline with age, causing undesirable changes in the skin. Restylane binds to water and provides volume toeasily fill in larger folds of skin left by tissue loss around the mouth and cheeks. "This makes it a structural action," says Rhodes, "much like a chin implant." In contrast, cosmetics are defined as substances that cleanse, beautify, promote attractiveness, or alter the appearance, without affecting the body's structure or function. This definition includes skin-care products such as creams, lotions, powders and sprays; perfume; lipstick; fingernail polish; and more.
Different laws and regulations apply to each type of product. Some products must comply with the requirements for both cosmetics and drugs. This happens when a product has two intended uses, such as an antidandruff shampoo. A shampoo is a cosmetic because it is intended to clean hair. An antidandruff shampoo is a cosmetic and a drug because it is intended to treat dandruff (which affects the follicles where the hair is formed) and clean hair.
Warning letters issued by the FDA recently to firms that marketed hair care products with claims such as restoration of hair growth and hair loss prevention illustrate an important distinction between the legal definitions of cosmetics and drugs. Warning letters officially inform companies that they may be engaged in illegal activities, and instruct manufacturers on how to bring their products into compliance with the law. Hair growers and hair loss prevention products, because of their mechanism of action, are considered drugs, not cosmetics, and these firms were not meeting the legal requirements for marketing a drug.
Unlike drugs and medical devices, neither cosmetic products nor cosmetic ingredients arereviewed or approved by the FDA before they are sold to the public. The agency only acts against cosmetic products found to cause harm after they are on the market.
Cosmetics or Drugs?Much confusion exists about the status of cosmetic products having medicinal or drug-likebenefits, 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 usedfor 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 EffectsMany cosmetic treatments are the result of common disease therapies whose unexpectedside 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 thistime.
"The fact that we don't participate in that market right now-I'm not sure that's reflective ofany particular deliberation or decision," he says. "That's just not where the science hastaken us." Before electing to have a cosmetic procedure Discuss it with a physician who can refer you to a specialist in the fields ofdermatology and aesthetic plastic surgery. Begin with a consultation to find the right doctor, and select one who is qualified todo the procedure you want. Make sure the doctor you choose is certified by an appropriate medical board.
Have realistic expectations about the benefits you want to achieve. Compare fees--insurance does not usually cover elective procedures.
Saving FaceAccording to the American Society for Aesthetic Plastic Surgery (ASAPS), nearly 7 millionAmericans 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 living90-plus years, today's anti-aging modalities offer people noninvasive procedures thatmimic true facelifts," says Craig R. Dufresne, M.D., a plastic and reconstructive surgeon inChevy Chase, Md., who performed Bradbard's surgery. However, Dufresne says hesuggested reconstructive surgery for Bradbard because "she wanted to deal withstructural changes to restore facial balance," which was more than the chemical action ofa drug could produce. "And skin product application (such as wrinkle fillers) following afacelift," adds Dufresne, "will actually allow the facelift or any other reconstructiveprocedure to last longer and make a great result even better." Top 5 Cosmetic Nonsurgical Procedures(2002) Source: American Society for Aesthetic Plastic Surgery Source: American Society for Aesthetic Plastic Surgery Seeking Professional AdviceSince it is often difficult for people to determine the validity of claims made about topical products and to decide among the overwhelming number of anti-aging procedures, how do people know what's right for them? "A good place to start is with a dermatologist," says Arielle N.B. Kauvar, M.D., clinical associate professor of dermatology at the New York University School of Medicine. "Dermatologists are trained in the health, function and disease state of the skin, and people could save time, money and confusion by seeking the advice of a dermatologist rather than guessing what might work for them." Kauvar says a dermatologist's recommendations can help consumers make informed decisions. "People shouldn't hunt and peck for products," she adds. "Not knowing what type of skin you have is why so many people try unnecessary products that can often do more harm than good." An expert in laser procedures, Kauvar says that, in the past, techniques for improving aging skin required invasive laser or surgical procedures, which produced open wounds and required long recovery times. Today, she says, people can choose from a variety of non-ablative (non-wounding) laser treatments that are designed to reverse, improve or erase the early signs of aging, take very little time to perform, and have a minimal, if any, recovery time.
While Bradbard wasn't interested in removing wrinkles at the time of her facelift, given what she knows about new technologies and drug delivery systems today, she says, "I would consider both non-invasive procedures and another facelift down the road, depending on how much my skin changes. I would ask my doctor what would give me the best results with the longest-lasting effects." Buyer BewareAnti-aging products that promise to diminish wrinkles and fine lines are found on many store shelves. However, dermatologists recommend that people consider only those procedures and products that have proven, over time, to be most effective at reversing theaging process. Most doctors agree that the leading product to prevent premature wrinkles and sun damage is sunscreen. A broad-spectrum sunscreen that protects the skin from both UVA and UVB rays, with a sun protection factor (SPF) of 15 or higher, can prevent the skin from looking older than it is.
According to the ASAPS, it's important to realize that although certain products and procedures are effective, they are also limited by the skin's normal aging process. A product that has been deemed effective for erasing wrinkles doesn't necessarily erase wrinkles--there are lots of variables that determine its effectiveness.
For example, the active ingredient in a drug must be delivered to the skin at a therapeutic concentration and remain in the skin long enough to have an effect. Also, because the composition of a man's body differs from a woman's, products or procedures can have different effects. The facial area in men contains hair, for example, and their skin is thicker. This means the blood supply is greater--and so is the risk of bleeding--but it also could mean better healing.
And cosmetic procedures come with risks. If a procedure is performed poorly, the physicaland emotional scars could be carried for life. Understand the risks and side effects that may be involved.
"My wanting to improve my appearance is like my husband's desire to restore a vintage automobile," says Bradbard. "We both want something to look good for as long as it can." American Academy of Dermatology PO Box 4014, Schaumburg, IL 60168-4014 (888) 462-3376 American Society for Dermatologic Surgery5550 Meadowbrook Drive, Suite 120, Rolling Meadows, IL 60008(800) 441-2737 American Society for Aesthetic Plastic Surgery11081 Winners Circle, Los Alamitos, CA 90720(888) 272-7711 FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility


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