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FDA's "PHYSIOLOGIC" DEFINITION OF DRUG

Executive Summary

FDA's "PHYSIOLOGIC" DEFINITION OF DRUG v. COSMETIC SKIN CARE CLAIMS ignores the interactive relationship between the stratum corneum and the epidermis, a coalition of 12 skin care manufacturers maintained in a Sept. 11 proposal to FDA. The "stratum corneum and the epidermis operate as an integrated unit; whatever affects one inevitably affects the other," the proposal states. Therefore, FDA's assertion that a "proper cosmetic would exert its 'physical' effects only on the stratum corneum" is not correct, the proposal asserts. According to the proposal, FDA defines cosmetics as products having only "physical" effects on the skin and those products which have a "physiological" effect on the structure or function of the skin as drugs. To FDA, "a product is a drug even though sold only to improve the appearance of the user if it is claimed to achieve this purely cosmetic effect by 'physiological' as opposed to 'physical' means," according to a summary of FDA's position by the skin care coalition. The proposal was submitted as part the coalition's effort to arrive at an acceptable definition of cosmetic claims for skin care products. The group had submitted an earlier proposal to the agency in July ("The Pink Sheet" Aug. 3, T&G-4). The firms in the coalition received regulatory letters from FDA for promoting their products as effective against skin aging. The agency considered the promotions to be unapproved new drug claims. However, the coalition maintains that skin care research has shown that a variety of products and ingredients considered by both the public and FDA to be cosmetics "permeate" below the stratum corneum into the epidermis. These products or ingredients may "have a physiological effect or, through physical means, affect the physiology and therefore appearance of the skin," according to the proposal. For example, cosmetic ingredients "associated with significant absorption" into the epidermis or deeper include: panthenol, ascorbic acid, tocopherol acetate, butylated hydroxytoluene (BHT), an antioxidant, and lecithin, according to the coalition proposal. The coalition's proposal suggests a framework for identifying acceptable cosmetic claims in three areas: skin physiology, aging, and environmental protectants. For physiologic claims, the coalition said it is willing to "limit our discussion to the epidermis, and to place off-limits claims related to dermal mechanisms and effects." Claims about the aging process that are "product neutral" and are truthful and not misleading should be allowed, such as: "Everyday, ultra-violet light damages cells and ages your skin," the coalition maintains. Other aging-related claims that should be acceptable are those for the temporary reduction in appearance of fine lines, wrinkles or loss of elasticity, for example: "Helps reduce many signs of facial aging."

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