ISOThrive, Inc.
FDA issued this warning letter to ISOThrive, Inc. (CEO Jack Oswald) following a June 2023 inspection under the Bioresearch Monitoring Program. The agency found that ISOThrive conducted two clinical investigations of an investigational drug — marketed commercially as a dietary supplement — on a combined 288 human subjects without first submitting or having in effect an Investigational New Drug (IND) application, as required by 21 CFR 312. FDA determined the studies were designed to assess treatment of disease (not merely tolerability), making the product a drug under FD&C Act §201(g)(1) and disqualifying it from IND exemption. ISOThrive was directed to respond within 15 business days with corrective actions, with failure to do so potentially triggering further regulatory action.
Required actions (1)
Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future.
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