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OTC drugs labeling proposal could create barriers for multilingual labels, CTFA maintains.

This article was originally published in The Rose Sheet

Executive Summary

FDA OTC DRUG LABELING PROPOSAL COULD CREATE A BARRIER FOR MULTILINGUAL LABELS on cosmetic-drug products, Cosmetic, Fragrance and Toiletry Association VP-Legal/General Counsel Tom Donegan said at a May 8 OTC "feedback" meeting with FDA on the proposed rule on standardized OTC labeling. "We're concerned that the rule might go so far as to make [it] impossible" for companies to develop a "universal" label that can be used in the U.S. as well as Canada, the EU "and other parts of the world," Donegan maintained. CTFA has been working with both the Canadian and EU governments to harmonize labeling requirements.
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