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Executive Summary

FDA ACTION VS. ANTI-AGING PRODUCTS IN "SUBSTANTIAL VIOLATION" of agency regulations will be initiated within 30 days, FDA Associate Commissioner for Regulatory Affairs John Taylor said in a March 25 letter to 22 firms. The letter reiterates the agency's position that marketing statements claiming anti-aging properties for cosmetic skin treatments constitute unapproved new drug claims. Taylor's letter states: "Beginning 30 days after the date of this letter, any products found to be in substantial violation of the new drug and misbranding provisions of the [FD&C] act may be subject to regulatory action without prior notice." Although the letter does not set out what constitutes a "substantial violation" of the act, Taylor said that the agency believes it has "clearly stated its views regarding the types of claims that can be appropriately made on cosmetic skin care products and the types of claims that make skin products unapproved new drugs." Among the "drug claims" under fire from FDA are product claims to "counteract," "retard" or "control" aging, as well as "rejuvenate," "repair" or "renew" skin, the agency indicated in November. The letter responds to individual proposals that have been sent to FDA by a number of the companies over the past few months. The industry proposals outlined ways for FDA to correct regulatory violations in the marketing of the skin treatment products. FDA had asked for the industry input last November. Although all of the skin care marketers that responded to FDA's request indicated a willingness to make changes in labeling and/or advertising claims, the scope and specificity of the proposed changes varied significantly among the different companies, according to FDA. Taylor indicated FDA may be unwilling to negotiate on its strict interpretation of what constitutes a drug claim. "We do not believe," Taylor said, "that a detailed review or a prolonged discussion regarding individual product labeling proposals 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 companies cautioned by FDA include: Estee Lauder; Avon; Cosmair; Revlon; Chanel; Christian Dior; Elizabeth Arden; Shiseido; Clarins; La Prairie; Coty; Prince Matchabelli; Francis Denney; Princess Marcella Borghese; Orlane/Caron; Adrien Arpel; Almay; Rachel Perry; Max Huber Research Labs; and Jason Natural Cosmetics. This is the second time FDA has rejected the industry's position on these claims. When it requested individual proposals in November, the agency also rejected a 54-page proposal from a coalition of 12 skin care marketers attempting to broaden the definition of acceptable claims. By the end of April, companies will have had five months in which to initiate necessary changes to comply with FDA's position as stated at that time. The amount of time required to make the changes was one of the issues addressed in the individual company responses to FDA. While some marketers reportedly said they would move promptly to modify claims, others requested extended periods of time, according to FDA. Of the 23 receiving reg letters last spring, Alfin is the only one that has discontinued its skin care operations.

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