CLARINS REFORMULATING SUNSCREENS WITHOUT METHOXYDIBENZOYLMETHANE in response to an FDA regulator letter The firm informed FDA of its decision in a May 31 letter from its outside counsel Eugene Lambert (Covington & Burling). Clarins will "not dispute the position . . . that it should not use methoxydibenzoylmethane as an active ingredient in a sunscreen drug product in the absence of an approved new drug application, " Lambert said. In a regulatory letter issued in February, FDA alleged that methoxydibenoylmethane is a "new drug" requiring premarket approval. The agency asserted that the ingredient was not recommended by the OTC Topical Analgesics Panel in its report on sunscreens. In addition, the agency said it is unaware "of any substantial scientific evidence which establishes that this ingredient is generally recognized as safe and effective for its intended uses." Lambert indicated that Clarins will consider filing an NDA for the ingredient. "As soon as practicable, technical personnel from the company will meet with representatives of the Division of the Anti-infective Drugs to detemine what information would be necessary to process an NDA," Lambert said. The Clarins products that list butyl methoxydibenzoylmethane as an active ingredient are: Clarins Total Sun Screen, SPF 9; Clarins Sun Wrinkle Control Cream, SPF 6; Clarins Sun Care Milk, SPF 4.5; Clarins Sun Care Milk, SPF 3.5; Clarins Self Tanning Milk, SPF 3.5 and Clarins Sun Care Oil, SPF 2. FDA said the firm may sell the remaining stock of its sunscreen containing the ingredient and that a recall is unnecessary since the ingredient poses no imminent danger. The FDA action and Clarins' response may put other firms on notice. At least one other firm, Avon, is understood to be using the ingredient in several skin care lines.
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