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This article was originally published in The Tan Sheet

Executive Summary

ALCOHOL MAXIMUM CONCENTRATION OF 5% "PREFERRED" BY FDA although the agency is allowing an alcohol maximum limit of 10% for systemic OTCs under a proposed rule published in the Oct. 21 Federal Register. The agency proposed in the rule that "OTC drug products for oral ingestion should not contain more than the minimum amount of alcohol needed as a solvent for the active ingredient, for preservative purposes, or for taste enhancement." FDA invited "specific comment on the proposed 10% maximum alcohol concentration, including specific data and reasons that might support lowering this concentration to a 5% limit." FDA suggested in the proposed rule that "lower concentrations would help limit potential misuse of products for their alcohol content and reduce undesirable alcohol ingestions by adolescents." However, FDA said it has not received data that demonstrate "a difference in safety between 5% and 10% alcohol" in orally ingested OTC drugs. The proposed rule would set a mandatory maximum limit for alcohol concentrations in OTC systemic products at 10% for anyone 12 years of age and over, at 5% for products aimed at children six to under 12 years of age, and at .5% for children under six years of age. The maximum concentrations proposed by FDA conform with the recommendations made by the agency's OTC Drug Advisory Committee at its inaugural meeting in December 1992. At the meeting, the committee decided to adopt the limits recommended by the Nonprescription Drug Manufacturers Association in a voluntary industry program announced prior to the meeting. The committee also discussed the appropriate level of alcohol in OTC products including the pharmaceutical role of alcohol, the pharmacokinetics and pharmacodynamics of alcohol, safety issues concerning specific levels of alcohol in OTC drugs and labeling requirements for products with alcohol. FDA, however, is proposing to make the alcohol limits mandatory. The agency noted that "a voluntary program may not involve all OTC drug manufacturers and their products" and "would not be enforceable by the agency." FDA said it intends to implement the proposed alcohol limits as well as related labeling requirements through NDAs and final monographs. Alcohol content statements would have to appear both on outer packaging and on the product container. The proposed rule states that a "product's alcohol content should be prominently and conspicuously displayed in the product's labeling . . . and visible to consumers at the time of purchase." FDA is proposing that alcohol content levels "appear on the front (principal) display panel of the product's labeling and that the information be in a size reasonably related to the most prominent printed matter on the panel." FDA noted that alcohol content "will also need to appear on the immediate container label when the immediate container is marketed in another retail package." This "dual labeling," FDA suggests, will be helpful for consumers at the time of purchase and for later usage once the outer package has been discarded. Labeling for OTC products containing alcohol would also have to include directions that suggest physician supervision when using a product for children under a certain age. In addition, the proposal states that "if age limitation statements differ" for other ingredients in the product, then "directions referring to the higher age limitation should be used." Products containing less than 5% alcohol will not be able to claim "alcohol free," as proposed by NDMA. FDA maintains that "this designation would be misleading because it infers that the product contains no alcohol whatsoever," which FDA said could be potentially harmful for individuals taking an alcohol-deterrent medication. FDA will allow the "alcohol-free" claim for products that do not, in fact, contain any alcohol. FDA estimates that a limited number of orally ingested OTC products will be affected by the regulation due to their alcohol content level, including certain OTC liquid cough-cold products, internal analgesics and laxative drug products. Written comments on the proposed rule will be accepted by FDA until until January 19, 1994.

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