LOW-DOSE TOLNAFTATE EFFICACY STUDY FOR ATHLETE'S FOOT
This article was originally published in The Tan Sheet
Executive Summary
LOW-DOSE TOLNAFTATE EFFICACY STUDY FOR ATHLETE'S FOOT will be sponsored by Westport, Conn.-based Winning Solutions to support inclusion of a lower allowable dose of the ingredient tolnaftate in the FDA antifungal monograph. Winning Solutions petitioned FDA to keep open the OTC Topical Antifungal Drug Products monograph in order to "provide additional time" to prove the efficacy of tolnaftate at a dosage level of less than 1%. Winning Solutions has contracted Carrollton, Texas-based Stephens and Associates to conduct a 200-patient study testing .1% and .5% tolnaftate against the 1% dosage level required under the 1982 tentative final monograph. Winning Solutions indicated the study would begin "shortly." In a July 30, 1993 citizen petition, Winning Solutions said the study will "determine if a lower level of tolnaftate, specifically a level of less than 1%, in an aloe vera-based antifungal lotion for topical application in the treatment of athlete's foot, is as effective as the 1% level approved" by the OTC anti-microbial panel. To support the petition, Winning Solutions provided FDA with the results of a 1992 in vitro study that, according to the company, "indicate that lower levels of tolnaftate . . . provide nearly the same results as those at the 1% level." In addition, Winning Solutions asserts that consumers are "best served" by products containing lower levels of tolnaftate "because the consumer cost per ounce is significantly lower, and because the need for a higher level of tolnaftate is not necessary to obtain the antifungal effect desired." Founded in 1981, Winning Solutions sells a variety of aloe vera cream and lotion products including: Miracle Rub, an arthritis pain reliever, V-loe, an anti-itch vaginal cream; and Chafe-Guard, an anti-chafing lotion. Winning Solutions products are available only through mail order catalogues such as Harriet Carter Gifts, Solutions, Vermont Country Store, Nature's Bounty, Nutrition Warehouse and Star Vitamins. The company's products are not supported by national advertising. Winning Solutions received a warning letter from FDA on June 9 relating to the company's promotional claims for its low dose tolnaftate/aloe vera athlete's foot product Miracle Foot Repair as well as the product's formulation. In the letter, FDA notes that the current formulation of Miracle Foot Repair -- .1% tolnaftate, 60% aloe-vera and Salicylic Acid -- is not included in the OTC antifungal TFM and, therefore, "may not be introduced into interstate commerce." In response to Winning Solutions' proposal to relabel the product by placing aloe vera in the list of inactive ingredients, FDA told the company that any claims concerning aloe vera that appear on the label should be deleted. "The featuring in the label of inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation is misleading," FDA states in the warning letter. Aloe vera claims that appear on the revised labeling include "Miracle of Aloe . . . 60% Aloe . . . Unique formula with 60% Aloe Vera gel and special polymers to penetrate." FDA also pointed out that "the labeling [for Miracle Foot Repair] fails to bear adequate directions for use for the conditions for which it is offered." In response to the letter, Winning Solutions said it is repackaging its product to address FDA's concerns. The company said that the new packaging for the product will include aloe vera as an inactive ingredient and will delete all claims for aloe in the labeling. Winning Solutions indicated that it will continue to market its low dose Miracle Foot Repair while FDA reviews the company's petition.