FDA Issues Warning Letter Over Dr. Goodenowe’s Unapproved Dementia Supplement Trial
FDA warns Moose Jaw health centre founder over unapproved dementia supplement trial
On February 1, 2026 CBC reported that the U.S. Food and Drug Administration issued a warning letter to Dayan Goodenowe, founder of Moose Jaw’s Dr. Goodenowe Restorative Health Center, after a 2020‑21 clinical trial of his product ProdromeNeuro was found to lack required regulatory approvals. The trial enrolled 29 patients with mild‑to‑moderate dementia and was published in 2022 in Frontiers in Cell and Developmental Biology. Goodenowe claimed the supplement was a natural dietary product and did not need an Investigational New Drug (IND) filing, a claim the FDA rejected because the product was marketed as a drug for disease treatment. The letter also noted that the study’s data integrity was compromised. Goodenowe is now facing investigations by Moose Jaw police, Saskatchewan’s consumer affairs regulator, and a Canadian health‑care probe.
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