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FDA sends "courtesy letters" to three zinc lozenge makers for cold claims.

This article was originally published in The Tan Sheet

Executive Summary

THREE ZINC LOZENGE MAKERS RECEIVE FDA "COURTESY LETTERS" stating that the products' structure/function claims to treat the common cold are drug claims. The FD&C Act "makes clear that a statement included in labeling...may not claim to diagnose, mitigate, treat, cure or prevent a specific disease or class of diseases," FDA points out in its May 22 letter to Rx Vitamins. "The statement that you are making for Zinc Lozenges suggests that this product is intended for at least one of these purposes in that it claims to reduce the duration of symptoms caused by the common cold," the agency declares
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