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FDA consumer comprehension OTC label study requires "more focused effort," CTFA declares.

This article was originally published in The Rose Sheet

Executive Summary

FDA CONSUMER COMPREHENSION OTC LABEL STUDY REQUIRES "MORE FOCUSED EFFORT," CTFA maintains in March 30 comments responding to the agency's over-the-counter drug labeling study, the "Evaluation of Proposed OTC Label Format Comprehension," or "Study A." FDA conducted the 1,200-subject study to examine the effectiveness of four different labeling formats in communicating the safety and efficacy of OTC products. Deeming the acquired study data "ultimately irrelevant" to labeling of cosmetic-drugs, the Cosmetic, Toiletry and Fragrance Association suggests FDA either "disregard this study [or] initiate a more focused effort to develop meaningful consumer research on OTC drug labeling." Results from Study A, completed in November, are available on FDA's Web site at www.fda.gov.
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