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Analgesic alcohol "specific warning" format may disrupt information flow -- NDMA.

This article was originally published in The Tan Sheet

Executive Summary

ANALGESIC ALCOHOL "SPECIFIC WARNING" FORMAT MAY DISRUPT FLOW of label information to consumers, the Nonprescription Drug Manufacturers Association says in Jan. 28 comments on FDA's proposed alcohol warnings for analgesics. Echoing its previous comments on FDA's proposed overall OTC drug labeling revision regs, NDMA objects to the requirement for "specific" warnings, such as the Reye syndrome warning, on OTC product labeling. "We continue to believe that this aspect of FDA's proposal may cause disruption of the logical flow of warnings information, depending on the OTC medicine, and consumer confusion as to the relative importance (or unimportance) of the warnings," NDMA states.
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