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Executive Summary

Coal tar OTC products for dandruff, seborrheic dermatitis and psoriasis will have to "state the equivalent concentrations of coal tar contained in any coal tar solution, derivative, or fraction used as the source of the coal tar in the product," according to a change in the final monograph for OTC dandruff products. The final rule was published in the Federal Register on Dec. 4; it becomes effective in twelve months at the beginning of December 1992. The agency is mandating more information on coal tar concentrations in response to a comment that requiring the equivalent concentration would allow "consumers to compare 'apples with apples' when comparing two coal tar-containing preparations," the notice states. The final rule for "Dandruff, Seborrheic Dermatitis and Psoriasis Drug Products for Over-the-Counter Human Use" lists five "monograph condition" ingredients that are safe and effective out of the 33 ingredients reviewed by FDA. The regulation lists as safe and effective: coal tar preparations and salicylic acid for dandruff, seborrheic dermatitis and psoriasis; pyrithione zinc and selenium sulfide for dandruff and seborrheic dermatitis; sulfur for dandruff; and a combination of salicylic acid and sulfur for dandruff. A change in the lower limit for concentrations of zinc pyrithione is confirmed in the final rule for rinse-off dandruff control products. The lower limit is dropped to 0.3% from the 0.95% proposed in the tentative final monograph. The lower limit remains 0.95% for the control of seborrheic dermatitis. FDA informed Head & Shoulders manufacturer Procter & Gamble of the change in July 1990 ("The Pink Sheet" July 23, 1990, In Brief). The company received an NDA for a 0.3% lotion as a conditioner in March 1986 (Head & Shoulders Conditioner). The rule also notes that the agency did not include 0.6% micronized selenium sulfide as a monograph ingredient. An agency review of five clinical studies submitted by Selsun Blue manufacturer Ross Labs found that the data were "insufficient to establish the effectiveness" of the micronized ingredient, the notice states. FDA wrote Ross of its final decision in May 1991. The company had requested the ingredient's inclusion in the monograph in the summer of 1987 and sent in additional study data in response to an Oct. 10, 1989 request from FDA. The rule does not allow a combination of menthol and coal tar, nor does it include the combination of salicylic acid and coal tar as monograph ingredients. American Home Products' Whitehall Labs subsidiary, which manufactures Denorex, had sought to have the menthol combination included in the monograph. Whitehall provided studies it said showed that 1.5% menthol relieved scalp itching associated with dandruff. FDA found that "the data do not demonstrate that the combination product offers any advantage over the single ingredients alone." FDA informed Whitehall of its decision on March 20, 1991. Neutrogena in mid-1987 had submitted a proposed clinical protocol to evaluate the effectiveness of 2% salicylic acid/2% coal tar for scalp psoriasis. The Dec. 4 notice states that FDA has not received any results from the proposed clinical and "accordingly, this combination is not included in this final monograph." FDA pointed out, however, that the data may be submitted via a citizen petition requesting a monograph amendment. The agency's final rule is based on a review of 33 OTC active ingredients. Twenty-eight of the 33 ingredients were designated by FDA as "nonmonograph" (formerly Categories II and III). FDA earlier had banned 27 of the OTC dandruff, seborrheic dermatitis and psoriasis ingredients, including pine tar and allantoin, under a catch-all proposed rule published Nov. 12, 1990 that eliminated a total of 130 Category II and 102 Category III OTC active ingredients from 19 drug categories ("The Pink Sheet" Nov. 12, 1990, T&G-7). Menthol is the 28th ingredient on the list on nonmonograph ingredients. The 28 ingredients designated in the final rule by FDA as nonmonograph for dandruff, seborrheic dermatitis and psoriasis are: alkyl isoquinolinium bromide; allantoin; benzalkonium chloride; benzethonium chloride; benzocaine; boric acid; calcium undecylenate; captan; chloroxylenol; colloidal oatmeal; saponated cresol; ethohexadiol; eucalyptol; juniper tar; lauryl isoquinolinium bromide; menthol; mercury oleate; methylbenzethoniun chloride; methyl salicylate; phenol; phenolate sodium; pine tar; povidone-iodine; resorcinol; sodium borate; sodium salicylate; thymol; and undecylenic acid. As a result of the publication of the final rule, OTC products marketed for "cradle cap" will have to be removed from the market. Cradle cap products include Diaperene Cradol, which contains the active ingredient methylbenzethonium chloride, a Dec. 4 FDA "Talk Paper" notes. Diaperene products are manufactured by Lehn & Fink. FDA published the advanced notice of proposed rulemaking on Dec. 3, 1982 and the tentative final monograph for the products on July 30, 1986. FDA Commissioner Kessler signed off on the final rule on July 31 of this year, but it took four additional months before the reg cleared further reviews and reached the Federal Register.

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