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J&J CLEAN & CLEAR ACNE PRODUCTS LABELING CHANGES

This article was originally published in The Tan Sheet

Executive Summary

J&J CLEAN & CLEAR ACNE PRODUCTS LABELING CHANGES are being prepared by the company to bring the products in compliance with the FDA final monograph for over-the-counter acne products. Johnson & Johnson expects to submit a proposal for its label changes to FDA within the next two weeks. The company's action follows the receipt of a Nov. 1 warning letter from FDA citing one of its Clean & Clear acne products, Oil Controlling Astringent. The warning letter states that "while the article does contain an active ingredient in compliance with [the monograph], it fails to bear the required labeling." The agency pointed out that "the label lacks the appropriate statement of identity . . . indications . . . warnings . . . and directions for use." FDA also noted that "the labeling requirements listed in quotation marks [in the rule] must be declared on the label exactly as stated." Clean & Clear Oil Controlling Astringent contains 2% salicylic acid. While only one product was cited by the FDA warning letter, J&J said it plans to revise labeling for all acne products in the Clean & Clear line. In addition to the astringent, the acne products include Blemish Fighting Pads and Blemish Fighting Stick. Other products in the line are a Foaming Facial Cleanser, Facial Cleansing Bar and Skin Balancing Moisturizer. J&J acquired the Clean & Clear line from Revlon in late 1991, shortly after the final monograph on OTC acne products was issued in August 1991. Although the line was restaged by J&J in the fall of 1992, some labeling was apparently not revised to accommodate the new requirements of the final acne rule. J&J's restaging involved reformulation and reinforced promotional activity, including a total ad spending allocation of approximately $ 8 mil. in the first year.
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