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Consumer OTC Drugs

GumTech Relabeling DentaHealth Gum after Receiving "Courtesy" Letter

This article was originally published in The Tan Sheet

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Executive Summary

GumTech International is planning to change the labeling of DentaHealth Gum from a dietary supplement format to meet drug labeling requirements after receiving an Aug. 18 "courtesy" letter from FDA stating the anti-plaque claims made for the product are unapproved new drug claims.

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