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Controversy at the Cosmetics Counter : Beauty Firms and the FDA Debate How Anti-Aging Products Can Legally Be Marketed

Monday, in Washington, representatives of many of the nation’s largest cosmetics companies will meet with the Food and Drug Administration to determine how to legally market products now making “anti-aging” claims.

Earlier this year, the FDA issued 23 regulatory letters to various firms, including Revlon, Estee Lauder and Avon, regarding their anti-aging treatments. Such products are claimed to rejuvenate the skin, the FDA says, and for them to do so, they must affect the physiology of the skin. Therefore, the products are drugs subject to FDA approval under the Food, Drug and Cosmetics Act, the agency explained in its letters. The act established the definitions of cosmetics and drugs in 1938.

“In all cases, the regulatory letters were sent because of label statements,” Heinz J. Eiermann, director of the color and cosmetics division of the FDA, says. “Because of the claims, the agency has taken the position that the products are new drugs. The law prohibits the marketing of new drugs without an approved new-drug application. That means that the companies have to demonstrate to the FDA that the products are safe and effective under conditions of use claimed in their labeling. The question of safety is not at issue; we’re just saying to these companies that you have not proven to the FDA that your products are safe and effective. The approval should have been obtained before the products were put on the market.”

Shortly after receiving the letter, a spokesman for Avon said it “will take the position that these are cosmetic products, and these are cosmetic claims.” Other manufacturers complained that the 49-year-old law is not in step with cosmetics technology. William Pendergast, a Washington attorney who represents Estee Lauder, says laws governing cosmetics “have to grow with science. The FDA has to be flexible. It has always worked that way for food and drugs. However, we think we can accommodate 1987 science to the 1938 law.”

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Washington attorney Stuart Pape, who represents several firms involved, declined to comment until after the meeting.

Some critics say the beauty industry does not want its anti-aging products to be labeled as drugs because it does not believe that they can stand up under FDA scrutiny. Consumer advocate Ralph Nader, for one, calls anti-aging claims “ridiculous.”

Nader, founder of the Center for Study of Responsive Law in Washington, says: “Cosmetics firms are trying to have it both ways--making drug claims without tests for efficacy. . . . If anti-aging products did what they claim, they would be drugs. But the point is they don’t work.”

By definition, a cosmetic cleanses, promotes attractiveness, beautifies or alters the appearance, but it does not claim to do so by changing the body’s structure or function, Eiermann says.

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“The lay person understands the word drug to mean a product that has some therapeutic effect, like cold medicine,” he says. “But under the law, a drug is a product that intends to affect the structure or functions of the body. Therefore, an antiperspirant is legally a drug because it claims to reduce the flow of perspiration. A wrinkle is not a disease; however, a product that claims to reduce wrinkles is intended to alter the structure of the body and therefore is legally a drug.”

Products such as Avon’s Bioadvance, Christian Dior’s Capture, Estee Lauder’s Night Repair and Alfin’s Glycel, which use scientific-sounding ads and label statements to make claims about their effects, blur the line between drugs and cosmetics.

Ads for Glycel, for example, are particularly controversial because they include the endorsement of heart-transplant pioneer Dr. Christiaan Barnard. The copy describes how Glycel’s active ingredient “penetrates the outer layer of the skin” via a “transdermal carrier system” to the skin’s basal layer.

Consumers may be distressed to find their favorite creams missing from store shelves until the disputes are settled. But Nader says the FDA is acting in the public’s interest in this case.

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If a product makes unrealistic claims, “the consumer is left with another disappointment,” he says. But if the FDA determines that anti-aging treatments are drugs--and if they pass the agency’s tests--consumers then can choose from among highly sophisticated products that they know are safe and effective.


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