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OTC antacids

This article was originally published in The Tan Sheet

Executive Summary

FDA extends comment period to May 4, at the request of NDMA, for a proposal that would disallow claims for overindulgence on sodium bicarbonate-containing antacids, according to an April 14 Federal Register notice. In a March 28 letter to FDA, NDMA argued that most companies marketing such products "were not anticipating changes in the monographs for antacids" and therefore "have had insufficient time" to address issues brought up in the notice. The Feb. 2 proposal originally carried an April 4 deadline for comments ("The Tan Sheet" Feb. 7, p. 4)

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