Skin-Care ‘Drugs’? : Are Anti-Aging Creams More Than Cosmetics? Congress Hears Pros and Cons

NEXT WEEK, THE second in a series of House subcommittee hearings will examine the question of federal regulation of so-called anti-aging preparations in the $17-billion cosmetics industry. And for the first time, the big question about anti-aging products will be asked formally: What do they actually do?

Rep. Ron Wyden (D-Ore.), chairman of the Small Business subcommittee on regulation and business opportunities, believes that the cosmetics industry is “virtually unregulated” and questions whether anti-aging preparations, which promise reduced wrinkles and “younger” skin, should be treated as cosmetics. Wyden wonders if they should instead be considered drugs.

“These products have properties that can alter the structure of the skin,” he asserts. Moreover, he says, “We don’t know how safe these products are. And by the existing law, we couldn’t find out if we wanted to.”

The congressman cites products touted by advertisements and labels that claim that they “speed up the cell-renewal process,” “repair” the skin and make wrinkles “lift upward.” “The efficacy of such miraculous products would require active ingredients working well below the skin surface. ‘Speeding up the cell-renewal process’ implies a product containing far more than a little pigment and some moisturizer,” Wyden says.

Anti-aging products’ claims have been under fire for more than a year. The Food and Drug Administration has complained that if the lotions and creams could, in fact, do what their labels claim, they would indeed be drugs and thus be subject to extensive testing for safety and efficacy. The FDA, if it believes that a product has been mislabeled, has the authority to seize it.

In this case, any cosmetic with a label, packaging or advertising that contains a therapeutic claim would be considered a mislabeled product by the FDA. Complying with the federal agency’s demands, cosmetics companies have softened the language in their newest advertising and promotional material. However, the FDA has no way to regulate how the products affect the body.

According to a law written in 1939, a drug is defined as anything that alters the structure or function of the body. In contrast, cosmetics are supposed to simply cleanse, beautify, promote attractiveness or alter appearance without affecting the body’s structure or its functions.

Gary Grove, a skin physiologist and vice president of Philadelphia’s Skin Study Center, a laboratory that tests consumer products--primarily cosmetics--for manufacturers, agrees that the law should be re-examined.

“Fifty years ago, no one could foresee the advances in the field of cosmetics,” says Grove, who testified at Wyden’s first House subcommittee hearing in mid-July. “Today there are ingredients used in skin-care products that could alter the skin’s structure and function.

“I’m not anxious about the safety of what’s out there now because major cosmetics companies are very concerned about safety. They test their products. I’m more concerned about the future, when small companies, which don’t have the money to do sufficient testing, start selling anti-aging products.”

Wyden points out that the FDA currently does not have the funds or manpower necessary to safety-test existing and new cosmetic products, even if it had the authority to do so. “Nor does it have the authority to require that manufacturers prove the safety of products before they are marketed.”

However, major cosmetics companies have voluntarily tested products, and industry organizations have developed guidelines for testing and manufacturing procedures.

Grove cites the work of the Washington-based Cosmetic, Toiletry and Fragrance Assn., an organization of more than 250 cosmetics companies, which, since 1970, has conducted cosmetic-ingredient reviews that determine the safety of commonly used materials. However, Wyden points out, the group so far has only investigated about 300 of the more than 4,000 ingredients estimated to be used in today’s cosmetics.

Grove suggests that anti-aging products could be treated similarly to over-the-counter drugs. Such treatment would not require a complete revision of existing law.

Over-the-counter drugs are governed by monographs that stipulate that ingredients be approved by the government. “There’s an argument to be made for having monographs for anti-aging products,” Grove says. “That would put them in the drug category. Cosmetics companies wouldn’t like that, but it would be appropriate.”

Styling: Karen O’Neil