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FDA OTC label comprehension studies do not target low-literacy consumers -- CTFA.

This article was originally published in The Rose Sheet

Executive Summary

FDA OTC LABEL STUDIES TEST CONSUMER PREFERENCE, NOT INFORMED DECISIONS, CTFA maintains in June 13 comments to the Office of Management & Budget. Responding to a call for comments by FDA on its proposal to conduct four consumer OTC drug label comprehension studies, the Cosmetic, Toiletry and Fragrance Association asserts that "major parts of the research seem directed at testing consumer preferences...rather than determining whether the new label formats will in fact produce more informed and appropriate decision-making about the use of OTC products." The "proper goal is not what the consumer prefers, it is what label information and format will best enable the consumer to properly use these products," the trade group maintains.
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