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Warning letter

This article was originally published in The Tan Sheet

Executive Summary

Online retailer of Immune-Assist 247 supplement Anthony Peters receives an FDA warning letter for labeling that contains "serious violations" of the FDC Act. Claims on the website tout the product as an "adjunct therapy in HIV" treatment and report "amazingly positive" results for the product in human trials for HIV and hepatitis C. These claims and others classify Immune-Assist 247 as a drug under the FDC Act because the product is intended to diagnose, cure, mitigate, treat or prevent a human disease, FDA maintains. Additionally, the firm also is in violation of the FDC Act for marketing an unapproved new drug since a New Drug Application (NDA) has never been submitted for the product. FDA requests a response from Peters within 15 business days outlining the steps he is taking to rectify the violations...
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