ACTIVATED CHARCOAL CATEGORY I RECLASSIFICATION IS SUPPORTED by analysis of a new study, Requa Inc. contends in an Oct. 14 citizen petition submitted to FDA. Requa, manufacturer of Charcocaps, is seeking classification of activated charcoal as a Category I digestive aid for the indication of "relief of symptoms of gastrointestinal distress such as gas, pain, or cramps which occurs after eating." Activated charcoal was listed as Category III under a tentative final monograph issued Jan. 29, 1988. Requa said it "received assurance" from FDA at an October 1988 meeting "that one study attaining significant results would satisfy the requirements for upgrading the classification of activated charcoal." The company submitted a report, entitled "Study of Activated Charcoal Capsules in Decreasing Gastrointestinal Gas," that was based on a protocol "developed with input" from FDA, Requa said. The study, conducted by Mark Riggs, PhD, for Requa, analyzed 41 patients who consumed a gas-producing "test meal" and experienced symptoms within an hour. They were then randomized to receive two capsules of activated charcoal or placebo, with the opportunity for two more every half hour. Patients rated their symptoms every 10 minutes for two hours on a scale from 0 (none) to 3 (severe) in four categories: "Fullness or Bloating," "Pressure or Distension," "Pain and/or Cramping," and "Flatulence." The study found a statistically significant reduction in the mean duration of "Pain and/or Cramping" from 70 minutes on placebo to 30 with charcoal. Patient ratings of "overall symptom relief" were also higher for charcoal than for placebo. Other categories showed no significant differences. Riggs notes, however, that among patients entering the trial, "the overall trend . . . was for a predominance of more severe symptom history in the charcoal group." When a subgroup of patients with more severe past symptoms was analyzed, charcoal showed a significantly reduced median time to total relief. Requa also includes in its petition previously submitted trials attesting to the efficacy of activated charcoal. "These findings," Requa maintained, "provide ample support for reclassifying activated charcoal to a Category I digestive aid ingredient."
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