ISOThrive, Inc. – FDA Warning Letter, Jun 30, 2023

The FDA issued a Warning Letter to ISOThrive, Inc. following an inspection from June 26 to June 30, 2023, which reviewed ISOThrive's role as a sponsor of clinical investigations for the investigational drug (b)(4). The inspection, part of FDA’s Bioresearch Monitoring Program, identified objectionable conditions and non-adherence to the Federal Food, Drug, and and Cosmetic Act (FD&C Act) and 21 CFR Part 312.

The primary violation cited was the failure to submit an Investigational New Drug (IND) application for clinical investigations of (b)(4), specifically Protocols (b)(4) and (b)(4), which enrolled 176 and 112 human subjects, respectively, between July 2020 and March 2021. ISOThrive argued these studies were IND-exempt because (b)(4) is a dietary supplement, and the studies focused on tolerability, not disease treatment. However, the FDA determined that (b)(4) was intended for use as a drug in these studies, as it was investigated for treating specific diseases, thus requiring an IND.

ISOThrive's July 20, 2023, response to the Form FDA 483 was deemed inadequate as it lacked sufficient detail on corrective actions to ensure future compliance with IND regulations. The FDA emphasized that failure to have