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OTC INTERNAL DEODORANT FINAL RULE: CHLOROPHYLLIN, BISMUTH SUBGALLATE

Executive Summary

OTC INTERNAL DEODORANT FINAL RULE: CHLOROPHYLLIN, BISMUTH SUBGALLATE are the only ingredients recognized as safe and effective in the Final Monograph on OTC Deodorant Drug Products for Internal Use, published in the May 11 Federal Register. The final rule indicates chlorophyllin copper complex and bismuth subgallate "to reduce odor from a colostomy or ileostomy" and also indicates chlorophyllin "to reduce fecal odor due to incontinence." Effective May 13, 1991, no other ingredients can be used in products marketed OTC as internal deodorants. Activated charcoal was among the ingredients formerly marketed for the indication but not accepted as safe and effective by the Advisory Review Panel on OTC Miscellaneous Internal Drug Products in 1981, when the notice of proposed rulemaking to establish the internal deodorant monograph was first published. Significant changes from the Tentative Final Monograph on the odor reducers, published June 17, 1985, include the addition of a new warning for products containing chlorophyllin: "if cramps or diarrhea occurs, reduce the dosage. If symptoms persist, consult your doctor." The final rule also revises the upper limit of recommended dosage for chlorophyllin from 200 to 300 mg daily and specifies "children under 12 years of age: consult a doctor." The recommended dosage for bismuth subgallate is 200 to 400 mg orally up to four times daily. Chattem's Nullo chlorophyllin tablets is among the products specifically marketed OTC as an internal deodorant. Also published in the May 11 Federal Register is the final rule for OTC products proposed for treatment of hypophosphatemia (abnormally low plasma level of phosphate in the blood) and hyperphosphatemia (abnormally high plasma level of phosphate). FDA decided that no ingredients should be available for OTC marketing to treat these conditions. FDA stated that hypophosphatemia and hyperphosphatemia "are not amenable to self-diagnosis or self-treatment," according to the notice. The final ruling is unchanged from FDA's TFM for phosphatemia published Jan. 15, 1985. The effective date of the final rule is Nov. 12, 1990. The final rule for hypophosphatemia/hyperphosphatemia also amends the monograph for OTC antacids. The rule revises the listing for aluminum phosphate, which is indicated for treating hypophosphatemia, to state that this ingredient is for use only in combination with other OTC antacid ingredients. The OTC antacid monograph is further amended to include professional labeling for a hyperphosphatemia claim for products containing aluminum carbonate. Although FDA believes OTC marketing of products specifically to fix phosphate imbalance would be inappropriate, since such conditions can only be detected by a doctor, the agency acknowledges that doctors already use aluminum-containing antacids to treat these conditions. For that reason, FDA decided to include professional labeling on the conditions for the OTC antacids. An accompanying change to professional labeling strengthens the warning against use of aluminum-containing antacids by renal-failure patients. The strengthened warning addresses the toxic effect of aluminum on bone mineralization in such patients.
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PS017428

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