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FDA BANS 102 CATEGORY III OTC DRUG INGREDIENTS

Executive Summary

FDA BANS 102 CATEGORY III OTC DRUG INGREDIENTS in a catch-all proposed rule published in the Nov. 7 Federal Register. The ban covers 19 over-the-counter (OTC) drug categories (monograph reports) including cold, cough, allergy, brochodilator and antiasthmatics; digestive aid drug products; dandruff/seborrhea, dermatitis/psoriasis products; and external analgesics. Manufacturers are required to discontinue the use of the listed ingredients by April 1991. In addition to the Category III (more study required for approval) ingredients, the notice also proposes to withdraw approximately 130 Category II (unsafe) ingredients. Following the broad sweep of the Nov. 7 notice and the previous action against 111 diet aid ingredients (see related item below), there will about two dozen monograph areas remaining with Category II and Category III items still on the market. The two recent actions appear to bring the agency within striking distance of cleaning up the bulk of Category II and Category III ingredients, without having to go through the painstaking monograph-by-monograph process. The product groups not covered by an existing final monograph or the catch-all notice include: antifungal, antimicrobial, external analgesic and skin protectant diaper rash products; skin protectants, external analgesics and internal remedies for fever blisters/cold sores; external analgesics for insect bites and stings and poison ivy/oak/sumac; internal analgesics for muscle cramps; topical hormones; menstrual products; oral health care antimicrobials; oral mucosal injury products; overindulgence remedies; pediculicides; skin protectants for insect bites and stings, poison ivy/oak/sumac and for use as astringents; sunscreens; vaginal drug products and contraceptives; and cough/cold combination products. In a Nov. 7 release, FDA cited four examples of products that would be required by the ban to drop ingredients. American Home Products' Donnagel, a diarrhea treatment, contains final rule-listed ingredients atropine sulfate, hyoscyamine sulfate and scopolamine hydrobromide, according to FDA. The firm said the product is being reformulated. FDA also named anti-dandruff treatment Tegrin Lotion (Block Drug) since it contains allantoin. Block is also reformulating its product. Pine tar, an ingredient banned for the indication of dandruff, seborrheic dermatitis and psoriasis, is found in GenDerm's Packer's Pine Tar Shampoo and Pine Tar Soap. The firm is reformulating the shampoo named by FDA, replacing pine tar with coal tar and a pine scent. GenDerm will begin shipping the reformulated shampoo after January. Rydelle Labs' Aveeno bath products line contains a banned ingredient: colloidal oatmeal. Colloidal oatmeal no longer is permitted as a treatment for dandruff, seborrheic dermatitis and psoriasis. Aveeno labeling in the Physicians Desk Reference for Nonprescription Drugs stops short of a direct indication for seborrheic dermatitis, stating that Aveeno "can be used in the care of itch due to dry skin, rashes, psoriasis, hemorrhoidal and genital irritations, poison ivy/oak, and sunburn." The firm has no plans to reformulate Aveeno. In the cold and cough remedies category, Warner-Lambert's Halls Mentho-Lyptus tablets contain eucalyptus oil, which was banned in lozenges as a cough/cold-treating agent. However, Halls contains menthol with the eucalyptus oil, a combination use okayed by FDA in an August 1988 tentative final monograph ("The Pink Sheet" Aug. 15, 1988, p. 6).

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