INGROWN TOENAIL FINAL RULE CONTAINS NO MONOGRAPH INGREDIENTS

INGROWN TOENAIL FINAL RULE CONTAINS NO MONOGRAPH INGREDIENTS and, therefore, any product marketed for that use will be considered a "new drug" by FDA, effective March 9, 1994. The ingrown toenail final monograph primarily affects two ingredients that had been listed in Category III (data insufficient to demonstrate safety and efficacy) in the September 1982 tentative final monograph -- tannic acid and sodium sulfide. In addition, FDA said in the final monograph that it is "not aware of any data that establish the safety and effectiveness of anesthetic ingredients for the relief of . . . pain" associated with ingrown toenail. Consequently, the agency added, "benzocaine, chlorobutanol, and dibucaine are nonmonograph conditions for this use." FDA ruled on the two Category II (not safe and effective) ingredients in the TFM -- chloroxylenol and urea -- as part of the agency's "negative monograph" rulemaking in November 1990 when FDA cleared out 232 Category II and Category III ingredients. Those ingredients, FDA noted, "have already been removed from OTC ingrown toenail relief drug products." The agency noted in the monograph that it is "only aware of a few products containing other ingredients" including "two combination drug products containing chlorobutanol and tannic acid and one containing benzocaine and tannic acid." Whitehall's Outgro, which contains 25% tannic acid and 5% chlorobutanol, and Schering-Plough's Dr. Scholl's Ingrown Toenail Reliever, which contains 5% tannic acid and 5% chlorobutanol, are among the products that will be affected by the monograph. Two studies in support of monograph status for tannic acid and two studies in support of sodium sulfide were submitted to FDA in response to the proposed rule on ingrown toenail ingredients. FDA said it reviewed the new clinical data and "determined that [the studies] are inadequate to support the effectiveness of tannic acid for the relief of ingrown toenails." The agency found that subject selection criteria in the first tannic acid study were not followed and that the grading scale used in the study was "highly subjective" and contained "inconsistencies between investigators and subjects." The second study, FDA said, looked at tannic acid's effect on skin hardening and did not address any other ingrown toenail symptoms and, therefore, could only "provide support" for tannic acid as a "skin hardener." FDA found that the sodium sulfide studies supported the ingredient's effectiveness. However, the study also showed a "high incidence of adverse reactions" including burning sensations and irritation. FDA concluded that the incidence of side effects and the need for subsequent professional advice "makes this ingredient unacceptable for OTC use."