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Ayurvedic Concepts GastriCare and Prostacare G-I, prostate claims are drug claims -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

GASTRICARE AND PROSTACARE G-I, PROSTATE CLAIMS CITED BY FDA as unapproved drug claims in a Jan. 6 "courtesy letter" to Houston, Tex.-based Ayurvedic Concepts. The Dietary Supplement Health & Education Act of 1994 "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," the letter states. "The statements that you are making for these products suggest that they are intended to treat or mitigate disease," FDA told the company.





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