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This article was originally published in The Tan Sheet

Executive Summary

LACTASE ENZYME SUBGROUP EXEMPTED FROM "NONMONOGRAPH" STATUS in a final rule removing 415 Category II (not recognized as safe or effective) and Category III (data insufficient to permit classification) OTC ingredients from consideration in seven separate monographs. Published in the May 10 Federal Register, the final reg removes Aspergillus oryzae enzymes from consideration, but adds parenthetically: "except lactase enzyme derived from Aspergillus oryzae." The agency explained that it received three comments pointing out that "new information on lactase enzyme derived from A. oryzae had been submitted to the administrative record in the rulemaking for OTC digestive aid drug products" and asking that Aspergillus oryzae enzymes therefore be deleted from the list of "nonmonograph" ingredients. Acknowledging that "lactase enzyme is the only enzyme derived from A. oryzae for which the agency has received any data in the rulemaking for OTC digestive aid drug products," FDA concluded that "the comments are correct in stating that this particular enzyme should be excluded from this final rule." Lactase enzymes are active ingredients in such OTC lactose intolerance products as Johnson & Johnson's Lactaid and Sterling Health's Dairy Ease. Camphor in concentrations exceeding 3% and menthol in concentrations exceeding 1% in fever blister and cold sore treatment drug products also were not included in the list of "nonmonograph" active ingredients. FDA noted that the ruling "was intended to apply to the higher (counterirritant) concentrations of camphor and menthol only." Aside from the two clarifications, the list of 415 Category II and Category III ingredients remains essentially unchanged from the proposed rule published on Aug. 25, 1992. OTC products containing these ingredients must come off the market by Nov. 10, 1993 or be reformulated, the notice stipulates. FDA explained that the 415 ingredients were removed from consideration because "no substantive comments or new data were submitted to support any of these active ingredients to monograph status." The ingredients cited will be considered nonmonograph "regardless of whether further testing is undertaken to justify further use," FDA declared. The agency suggested that "nonmonograph" ingredients may be used in OTCs "as inactive ingredients in product formulations . . . provided that no drug claims are made" for them. However, the agency added that the inactives should demonstrate "an appropriate purpose and be safe and suitable for use." The seven OTC monographs covered in the final rule include: digestive aid products; external analgesic drug products; skin protectant drug products; topical antifungal drug products; internal analgesic drug products; orally administered menstrual drug products; and pediculicide drug products. The final rule also denies a request by Kramer Laboratories "that the proposed prohibition of salicylic acid in OTC topical antifungal drug products be expressly limited . . . and not include its use as an adjuvant keratolytic." Kramer argued that "the criteria used by the agency to determine that an ingredient has been 'abandoned' have not been met for salicylic acid as an adjuvant keratolytic because the company had submitted data in support of the ingredient," according to the notice. In denying the request, FDA said it did not consider the submitted data "substantive."

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