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Rx WART REMOVERS MARKETED WITHOUT APPROVED APPLICATIONS

Executive Summary

Rx WART REMOVERS MARKETED WITHOUT APPROVED APPLICATIONS have prompted a round of warning letters from the FDA Center for Drug Evaluation and Research's Office of Compliance. At least 14 firms recently received warning letters about wart remover products. The products cited by FDA contain varying concentrations of salicylic acid and are sold as prescription drugs. "FDA is unaware of any substantial scientific evidence which demonstrates the above referenced drug product is generally recognized by qualified experts as safe and effective for the treatment of warts," the letter says. The agency added that it considers the products to be in violation of the FD&C Act since they are new drugs with no approved applications. The warning letter notes that "there are some manufacturers that market wart remover drug products as prescription drugs because they believe that such products are 'grandfathered' under the [FD&C Act]." Drugs are exempt from FD&C Act requirements only if they meet certain criteria; specifically, if the product "was marketed prior to June 25, 1938 [and] is exempt under the provision of section 201 (p) of the Act; or under section 107 (c) of the Drug Amendments of 1962 it must support any exemption by submitting evidence of past and present quantitative formulas, labeling, and also evidence of marketing." Any manufacturer that believes its product is exempt from section 505 "should submit the formulas, labeling and evidence of marketing," the letter states. Companies receiving the letter include Genderm (Occlusal-HP), Syosset Labs (Keratex gel and Verukan solutions) and Pedinol Pharmacal (salicylic acid cream, Sal-Acid plaster, Sal-Plant gel and Salactic film). Syosset Labs said it has stopped producing its wart remover drugs and Pedinol said it has ceased shipping its products. The agency pointed out that "the only legal mechanism now available for marketing wart remover drug products is as an OTC drug in full compliance with [the Final Rule for OTC Wart Remover Drugs] or as a prescription drug product covered by an approved new drug application." The final monograph was issued in August 1990 ("The Pink Sheet" Aug. 20, 1990, p. 11). The letter requests notification "within 15 working days of your receipt of this letter stating that you will discontinue the marketing of this drug or otherwise bring it into compliance."
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