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OTC ANTIFUNGAL PRODUCTS WILL NOT BE ALLOWED TO MAKE CLAIMS FOR NAIL OR SCALP

This article was originally published in The Tan Sheet

Executive Summary

OTC ANTIFUNGAL PRODUCTS WILL NOT BE ALLOWED TO MAKE CLAIMS FOR NAIL OR SCALP infections under an FDA final rule published in the Sept. 2 Federal Register. After reviewing two studies to support OTC product claims for treating nail and scalp infections, FDA concluded in the final rule "that there is no basis for the continued marketing of any OTC topical antifungal drug products with claims or directions for use on the scalp or nails." FDA is giving companies until March 2, 1994 to eliminate "any claims or directions for using an OTC topical antifungal drug product on the scalp or on the nails," the notice states. The final rule retains the OTC Antimicrobial II Drug Product Panel's recommendation that OTC topical antifungal products bear the statement: "This product is not effective on the scalp or nails." Several manufacturers already carry a similar statement in antifungal product labeling. Product labeling for Fisons' Desenex and Ting lines and Ortho's Micatin products indicate that the products are not effective for use on nails and scalp. FDA estimated that the rule will affect "about a dozen" OTC topical antifungal drug products marketed with claims for this use. In a Sept. 3 press release, FDA listed several products making nail claims, including Kramer Labs' Fungi-Nail and Lee Pharmaceuticals' Lee's Antifungal Nail Treatment. FDA agreed with the findings of the OTC panel, which decided that "fungal infections of the scalp and nails . . . respond poorly to topical therapy partly because of the thickness of the nails and the depth of the hair roots." The panel report concluded that "both sites of infection provide inaccessible location for fungi, thus drastically decreasing the penetration of topical antifungals." FDA has not yet issued a final rule on OTC antifungals. FDA said it has "elected to act on OTC topical antifungal drug products bearing [nail and scalp] claims before finalizing the rest of the monograph in order to expedite removal from the market of products that lack adequate evidence of effectiveness." FDA looked at two studies testing combination antifungal ingredients for safety and efficacy in nail infections that were submitted to the agency in response to the December 1989 antifungal TFM. One of the studies was a randomized, double-blind clinical comparison of a product containing a combination of antifungal ingredients, including undecylenic acid, acetic acid, salicylic acid chloroxylenol and benzocaine, to the product's alcohol and benzocaine vehicle. FDA determined that the study had a "major flaw in that it was not designed to demonstrate the contribution of each of the five active ingredients . . . to the effectiveness of the product's total formulation." The second study was an uncontrolled trial that FDA said "did not provide any useful information to establish effectiveness." Anticipating the upcoming antifungal final monograph, FDA pointed out in the Sept. 2 notice that "several of the currently marketed products will also need to be reformulated after the final monograph is issued because they either contain monograph ingredients at nonmonograph concentrations or certain combinations of ingredients that are not included in the final monograph."
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