Home / Health / FDA Scolds Supplement CEO Over Risky Trials
FDA Scolds Supplement CEO Over Risky Trials
1 Feb
Summary
- FDA warns Dayan Goodenowe risked patient safety in dementia study.
- Goodenowe failed to file required investigational drug application.
- Supplements claimed to reverse diseases like ALS and Alzheimer's.
The U.S. Food and Drug Administration (FDA) has issued a stern warning to Dayan Goodenowe, founder of Prodrome Sciences and the Dr. Goodenowe Restorative Health Center, alleging that a recent clinical trial placed research subjects at significant risk. The FDA's investigation, which began in December 2024, found that Goodenowe failed to submit an Investigational New Drug (IND) application before commencing a study evaluating his ProdromeNeuro supplement for mild to moderate dementia.
This failure to provide necessary safety data and ingredient details to the FDA has raised substantial concerns regarding the safety and welfare of the 29 participants enrolled between 2020 and 2021. The FDA stated this oversight compromises the integrity of the collected data. Consequently, the journal that published the study, Frontiers in Cell and Developmental Biology, issued an "expression of concern" and launched its own investigation into compliance with legislation.
Goodenowe, who is not a medical doctor, claims ProdromeNeuro, a blend of naturally occurring alkylglycerols, is a dietary supplement. However, the FDA asserts it was intended for treating disease, thus classifying it as a drug requiring an IND. This situation follows previous scrutiny of Goodenowe's claims, including a 100% success rate promise for ALS patients, which has been disputed by former clients. Despite these ongoing conflicts, Goodenowe announced plans for a $100 million expansion in Moose Jaw and further business ventures in China and Japan.
