Stop Anti-Aging Claims, FDA Says : Companies Get 30 Days to Change Labels of Skin Creams

The Food and Drug Administration told cosmetic companies Monday that they have 30 days to stop claiming their over-the-counter creams can reverse or retard aging of the skin.

In letters to 22 companies, the FDA effectively cut off discussions that started last spring when the agency warned the manufacturers that some of the claims they were making for their products might subject them to the same kind of regulation applied to drugs.

The latest letter said the time for talking has passed.

“We believe that FDA has clearly stated its views regarding the types of claims that can appropriately be made on cosmetic skin care products and the types of claims that make skin products unapproved new drugs,” wrote John M. Taylor, associate commissioner for regulatory affairs.

“Accordingly, we do not believe that a detailed review or a prolonged discussion regarding individual product labeling is necessary. We hope that you will make the changes in your labeling that are necessary to bring it into compliance with the act and with FDA’s stated views.”

The Food, Drug and Cosmetic Act defines cosmetics, which can be sold without pre-approval by the FDA, as products intended to cleanse or to beautify superficially.

Violations May Be Punished

When the FDA started questioning some claims being made for so-called anti-aging creams, the cosmetic companies said they wanted to work out a cooperative solution. The agency then agreed to a series of time extensions.

Some companies modified their labels, but the FDA said last November that it could not accept the labeling claims continuing to appear on many products.

The latest letter said the agency will examine the labeling and promotions of the creams in 30 days and that a product still in “substantial violation” may be subject to immediate regulatory action. This could include seizure of products on shelves and court injunctions against further distribution.

Although the letter went to 22 companies, the FDA said the policy applies to the entire industry.

In its warnings last year, the agency said that when a product is said to counteract, retard or control the aging process or to rejuvenate, repair or renew the skin, the statements are drug claims because they indicate that a “function of the body, or that the structure of the body, will be affected by the product.”

The FDA said it was “unaware of any substantial scientific evidence that demonstrates the safety and effectiveness” of the so-called anti-aging skin care products.

The FDA action does not involve Retin-A, a prescription acne medication that was widely publicized recently after a study suggested that it was effective in removing small wrinkles caused by sun damage to the skin.