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SKIN CARE CLAIMS: LEGISLATIVE UPDATE

Executive Summary

SKIN CARE CLAIMS: LEGISLATIVE UPDATE to bring the FD&C Act into line with scientific advances in skin treatment was urged by skin care product researcher Gary Grove, PhD, at a July 14 House subcommittee hearing on cosmetics safety issues. Grove contended that science may have outstripped the FD&C Act definition of a cosmetics claim versus a drug claim. He suggested that the subcommittee "carefully consider" whether the 50-year-old act "needs to be revised to reflect the recent technological advances made in cosmetic and skin care science." Grove, who is VP-R&D for the K.G.L. skin care research testing center and head of the University of Pennsylvania's Skin Study Center in Philadelphia, also suggested that cosmetics manufacturers be allowed to create "principles of conduct" guidelines to outline permissible marketing and promotional practices and to standardize methods used to determine what claims can be made for products. The hearing was held by the Small Business/Regulation and Business Opportunities subcommittee, chaired by Rep. Wyden (D-Ore.). The principles of conduct "should specifically advocate advertising claims that stress product performance claims that can be scientifically verified," Grove said. The principles "should also stress that all instrumental tests be relevant to the 'real world' and always be supported by appropriately designed subjective assessments by non-biased panelists and expert graders," Grove added. Grove's suggestion for more self-policing by the industry echoes FDA's approach in recent years and bears resemblance to a 1987 proposal to the agency from a coalition of anti-aging product skin care marketers. In addition, as an ad to ensuring accurate product labeling, FDA has proposed the establishment of a Cosmetic, Toiletry and Fragrance Association expert committee to set guidelines for defining cosmetic terms. Commissioner Young raised the idea most recently at CTFA's 1986 Annual Scientific Meeting. In 1987, a coalition of cosmetics companies which had received FDA regulatory letters for anti-aging skin care products with unapproved new drug claims proposed a "framework for reaching agreement on the metes and bounds of acceptable terminology." The proposal, which FDA rejected in November, also suggested that the agency should modify the application of the term "drug" for skin care products beyond its literal meaning under the Food, Drug & Cosmetic Act. Wyden's interest in the cosmetics industry appears to have been piqued by recent publicity for anti-aging cosmetics and FDA actions against them. In an opening statement, Wyden noted that over a year after the agency initiated regulatory action against certain skin care claims, "nearly all of these 'fountain of youth' products are still on the shelves. Many have not changed their claims and not one of them has been tested by FDA." The July 14 hearing was the first of several proposed by Wyden. At the next hearing, tentatively set for September, representatives of FDA, the Federal Trade Commission and the Occupational Safety and Health Administration are expected to testify.

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