FACE-OFF : Sales Wrinkles : Once a company claims that a product can affect skin beneath the surface, it becomes a drug rather than a cosmetic--and the rules change.

Few things seem to be as loathsome to American women as a new wrinkle or an old one that won’t go away. To prevent them--and get rid of ones they already have--consumers spend millions of dollars each year.

But just how effective are those daytime moisturizers and nighttime “repair” creams at stopping or reversing the tracks of time?

According to the federal Food and Drug Administration, not very.

Unlike drugs, cosmetics manufacturers are not required to conduct tests or submit their product to the FDA for pre-market approval. And, except for a few color additives and prohibited ingredients, manufacturers can use just about any raw material they want as a cosmetic ingredient.

But once a company claims that a product can affect the skin beneath the surface, repair cells, prevent the formation of lines or take existing lines away, the FDA’s regulations change.

The otherwise cosmetic product then legally becomes a drug--and must meet the pre-marketing testing and review requirements for a drug.

That process, according to the FDA, can cost a cosmetic manufacturer hundreds of thousands of dollars.

“In the last few years, there has been increased activity in terms of looking at cosmetics that make drug claims,” said Wayne Stevenson, who is with the federal Food and Drug Administration’s office in Washington, D.C. “FDA enforcement has been stepped up.”

The FDA, however, isn’t the only agency that takes an interest in the purported effectiveness of cosmetic products.

In the last few years, the Federal Trade Commission has sued several companies for what it asserted was deceptiveness in the advertising or labeling of products.

“Certainly, with cosmetics, it is a difficult line to draw between where the puffery is permissable--such as that you will look beautiful and gorgeous--and making assertions that are false or unsubstantiated,” said Ann Guler with the FTC’s Los Angeles office.

Guler said the FTC has asked several cosmetics companies to provide scientific substantiation for their claims, which they were unable to do.

What cosmetics claims have failed to pass muster with the FTC? Among them:

* The claim by one cosmetics company that daily use of its skin cream would “reduce the visible signs of aging” and provide “a beneficial environment for the skin’s natural renewal process.” The company was enjoined from similar claims about the product in October, 1991 and fined $100,000.

* The implication by one company that there is an abnormal condition called “acid skin” and that regular use of a specific cream could neutralize it.

* The advertisements by several companies that their products could “produce a youthful appearance” and “strengthen the muscles of the face.”

* The claim by one company that its product was made from the oil of cactus plants, which “lubricates skin to suppleness” and “stimulates fatigued glands into releasing precious drops of moisture” confined at the bottom of each pore.

* The claim that a product could restore so-called “youth glands” by releasing oxygen that is absorbed through the skin.

* The advertisement by a company that its product was made from substances extracted from living tissues, which had the ability to supply the skin with “precious youth-giving elements.”

Why are the advertisements followed so carefully and challenged so forcefully?

“With a TV or a calculator or other things consumers buy, it either works or it doesn’t,” said the FTC’s Guler. With cosmetics, “it’s difficult to know what is being accomplished and what constitutes a good value. People believe what they read.

“We see these kind of claims all the time,” she added. “When we do, we go after them.”