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This article was originally published in The Tan Sheet

Executive Summary

ACTIVATED CHARCOAL DECLARED NONMONOGRAPH DIGESTIVE AID INGREDIENT in FDA's final rule for OTC digestive aid products, published in the Oct. 21 Federal Register. "Although data and information were submitted on activated charcoal," FDA explained, "they were not sufficient to support monograph conditions." Although no monograph ingredients are listed in the digestive aid final monograph, FDA said it would address the status of lactase enzyme in a future amendment to the monograph if data submitted to the agency support monograph status. FDA noted that two manufacturers have submitted results of "several new studies" to demonstrate the effectiveness of lactase enzyme derived from Aspergillus oryzae and A. niger. FDA is "currently reviewing these studies and is awaiting additional information form both manufacturers," the notice states. The two companies that have submitted data are J&J, which markets Lactaid, and Sterling Health, which sells Dairy Ease. The agency had dealt with all other digestive aid ingredients in its "negative" monograph final rules in November 1990 and May 10, 1993 ("The Tan Sheet" May 17, p. 3). Following these two final rules, charcoal and lactase enzymes were the only remaining ingredients awaiting a determination of monograph status by the agency. FDA outlined six studies that were presented to the agency to support the effectiveness of activated charcoal and explained that the "majority of the studies are not presented in sufficient detail for an in-depth agency review." Additionally, FDA noted, the "statistical significance of the findings cannot be verified because of the absence of individual subject data which have never been provided." The agency also determined that the subjects used in five of the six studies were "inappropriate," stating that it is "necessary that the studies be conducted in a population where all subjects have the condition in question." Most of the studies presented relied on volunteers. One investigator used subjects with a history of meal-induced gastrointestinal discomfort but the sample size used (21 subjects in the activated charcoal group and 20 in the placebo group) was too small to demonstrate a "clinically important difference," FDA said. FDA is giving companies until April 21 to remove their activated charcoal-containing OTC products from the market after which time they will be "subject to regulatory action," FDA said. Greenwich, Conn.-based Requa currently markets CharcoCaps, a line of digestive aids containing activated charcoal. In late 1991, the company submitted a petition to the agency requesting that the ingredient be reclassified from Category III (data insufficient to permit classification) to Category I (safe and effective). In April 1992, FDA responded in a letter to the company that the data submitted "do not support the effectiveness of activated charcoal as a digestive aid ingredient for the relief of the symptoms of gastrointestinal distress" and accordingly, activated charcoal "cannot be reclassified to Category I based on these data."

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