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In Brief: NuCel Lab warning letter

This article was originally published in The Tan Sheet

Executive Summary

NuCel Lab warning letter: Labeling for Resolve Topical Progesterone Cream indicating the presence of a hormone or hormone ingredient "implies therapeutic benefit or a physiological effect," and causes the product to be an unapproved new drug, FDA says in an Oct. 24 warning letter. The ingredient statement declares an herbal progesterone discorea villosa extract (wild yam root and rhizome), the letter says. The product is misbranded, FDA adds, because it does not bear adequate directions for use...





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