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Warning letter cites hormone creams

This article was originally published in The Tan Sheet

Executive Summary

Louisville, Ky.-based Cosmed Labs receives a warning letter from FDA saying online information and labeling position four products as hormone-containing drugs. The products - AIM Renewed Balance Body Cream, Products of Nature Natural Woman Progesterone Cream, Products of Nature Relevamine GS and Dr. Janet's Glucosamine Cream - are listed in the Aug. 3 letter. FDA also points out a number of the "objectionable" claims, including one for the glucosamine cream stating "the ingredients in this formula work to soothe joints." The agency says the products are unapproved drugs because all topically applied hormone products, except those containing hydrocortisone, are considered new drugs. Further, three of the formulas are misbranded because the adequacy of their indications has not been established, and all four are adulterated because production methods do not conform to drug good manufacturing practices

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