FDA IRE TAKES ON NEW WRINKLE(S)

While straining with biomedical problems of literally life-and-death consequences, the Food and Drug Administration also is firing away at a benign fantasy, namely, that modern science can at last counter the fearsome aging processes that produce facial wrinkles. Prove it or deflate your advertising, the FDA recently warned half a dozen major manufacturers of skin creams and lotions for which wondrous qualities have been advertised.

Science actually can do little or nothing about the ravages of time, as evidenced by the inexorable march of crow's feet and creases, even in dermatologically free-spending high society, plus prosperity in the face-lift trade. But even so, there's reason to wonder why the hard-pressed FDA is challenging pseudo-scientific fairy tales that arouse such lovely hopes and inflict no harm. Unlike the deficit, the bomb, reignited inflation, and doctors' bills for the uninsured, wrinkles do not make the top 10 list in the pollsters' inventory of contemporary concerns. But, viewed against the cosmetic abundance that fills the world's drug stores and supermarkets, wrinkles obviously rank high on the index of silent human anxiety.Customers for anti-wrinkling compounds pay extravagant sums for the products that have drawn the FDA's ire. But a mere $50 to $200 an ounce is modest for such astonishing scientific triumphs as "night repair cellular recovery," "cell renewal," "a 59 percent average reduction in crow's feet," and rebuilding of "the intercellular network of your skin." The advertisement for one product says that it "helps fresh new skin cells surface faster." Another claims to provide skin with "vital nourishing supplements," and then there's a product that is said to assist "the proper uptake of oxygen and blood supply to the cells."

The customers pay willingly, even enthusiastically, and apparently without complaint, for the FDA mentioned no complaints in recently blowing the whistle against claims by such luminaries of the trade as Estee Lauder, Avon Products, Christian Dior, and Alfin Fragrances. The firms cannot be accused of exploiting the medically needy, since their products, unlike antibiotics and other life-saving drugs, are necessities only in a very selfish and optional sense. Furthermore, there's no danger that these enticingly described potions are diverting wrinkle sufferers from truly effective treatments. If any medicine could really defeat wrinkles, could it possibly remain top secret?

In dealing with cosmetics, the FDA usually confines its surveillance to safety and purity, and does not look too closely if all that's involved is a bit of paint, ointment and suggestions of romance just around the corner.

The big change is advertisements for the new anti-wrinkle compounds. They boast of profound biological interventions in the aging process, to the point where, the FDA charges,the manufacturers are suggesting that their products can "affect the structure and function of the human body." When that's involved, the law empowers the FDA to require the manufacturer to prove not merely safety and purity, but also effectiveness - which is very costly to study and difficult to prove, especially if it's not there.

The challenged manufacturers have asked for extra time to reply to the charge that they are claiming medicinal powers for their products and therefore must prove the value of their goods under the rules that govern pharmaceutical drugs. Delay can only mean that some of the greatest legal talent in the nation is being mobilized for a showdown over the public's right to pay monumental sums for harmless face creams.

In terms of legalistics, the FDA has a right to challenge the manufacturers' brazen claims. But the real question is, why bother? No one can say that the customers - all volunteers - are harmed or fleeced. After all, they keep coming back for more, even as nature takes its facial toll. The products in question have not aroused concerns about safety. Pricing is none of the FDA's business. Nor is fantasy, which is the principal ingredient of the cosmetics industry.

* 1987, Daniel S. Greenberg

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