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OTC Labeling Trade Dress Issue Resolved In FDA Technical Amendment

This article was originally published in The Rose Sheet

Executive Summary

Labeling of over-the-counter drug products may include light type on a dark background providing the combination results in a highly readable contrast, FDA asserts in a technical amendment to the OTC label reform rule published in the Jan. 3 Federal Register.

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OTC trade dress

CTFA supports FDA's technical amendment to OTC labeling rule, which loosens trade dress guidelines and allows use of dark-on-light and light-on-dark type. "The amended version of the final rule provides appropriate recognition of the value of trade dress" for manufacturers and consumers, the trade group says in March 17 comments. In previous verbal and written arguments, CTFA maintained that as originally drafted, the reg would restrict product distinctiveness. FDA granted the amendment in January (1"The Rose Sheet" Jan. 10, p. 9)

OTC trade dress

CTFA supports FDA's technical amendment to OTC labeling rule, which loosens trade dress guidelines and allows use of dark-on-light and light-on-dark type. "The amended version of the final rule provides appropriate recognition of the value of trade dress" for manufacturers and consumers, the trade group says in March 17 comments. In previous verbal and written arguments, CTFA maintained that as originally drafted, the reg would restrict product distinctiveness. FDA granted the amendment in January (1"The Rose Sheet" Jan. 10, p. 9)

OTC Drug Labeling Implementation Date Extended One Year To 2002

FDA is extending the OTC drug labeling implementation date to May 2002 to allow time for the agency to develop "forthcoming guidances" regarding a number of outstanding concerns from trade organizations.

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