Prodrome Sciences USA, LLC
FDA issued a warning letter to Prodrome Sciences USA, LLC (CEO Dayan B. Goodenowe, Ph.D.) following an inspection that found the company conducted a clinical investigation of ProdromeNeuro™ Oil on 29 human subjects with mild to moderate dementia without submitting a required Investigational New Drug (IND) application, in violation of 21 CFR 312. The company claimed the product was a dietary supplement exempt from IND requirements, but FDA determined the study design — including neurocognitive outcome assessments and enrollment of dementia patients — established the product was being investigated as a drug. FDA found the company's corrective action plan inadequate because it lacked sufficient detail on how future IND compliance would be ensured, and warned that failure to adequately address the deficiencies may lead to further regulatory action.
Flagged claims (3)
these dietary alkylglycerols are found naturally in shark liver oil, which makes ProdromeNeuro™ Oil a dietary supplement that does not require an IND
the protocol stated that one outcome of the study was to provide subjects with some improvement in their cognitive status
the objective of Protocol Pro‐040‐Plasm‐01 was to evaluate the safety and tolerability of ProdromeNeuro™ Oil as a nutritional supplement
Required actions (2)
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.
Failure to address this matter adequately may lead to regulatory action.
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