The U.S. Food and Drug Administration (FDA) has criticized the founder of the Dr. Goodenowe Restorative Health Center in Moose Jaw, Sask., stating that a recent clinical trial of his supplements jeopardized the safety of research participants.
In a warning letter released on Jan. 20, the FDA called out Dayan Goodenowe and his company, Prodrome Sciences USA, LLC, which produces pills and oils purported to aid in halting and reversing the progression of conditions like ALS, Alzheimer’s, and autism.
The FDA highlighted that from 2020 to 2021, Goodenowe enrolled 29 individuals in a clinical trial to assess the safety and tolerability of his product, ProdromeNeuro, for patients with mild to moderate dementia.
The study, titled “Targeted Plasmalogen Supplementation: Effects on Blood Plasmalogens, Oxidative Stress Biomarkers, Cognition and Mobility in Cognitively Impaired Persons,” was published in 2022 in the journal Frontiers in Cell and Developmental Biology.
Although the warning letter acknowledged the potential risks to patient health in the study, it did not report any adverse outcomes among the subjects.
This incident adds to a series of controversies surrounding Goodenowe. He has faced scrutiny from various sources, including the CBC, and is currently under investigation by Moose Jaw police and Saskatchewan’s consumer affairs regulator.
The FDA initiated an investigation in December 2024 and found that Goodenowe violated regulations by failing to submit an Investigational New Drug (IND) application before commencing the study.
An IND submission is necessary to provide the FDA with essential documentation, including animal testing data, to ensure the study does not expose participants to undue risks. The FDA’s warning letter raised concerns about the safety and integrity of the data collected during the trial due to the absence of this crucial information.
Following the FDA’s actions, the Frontiers journal issued a correction on the article, expressing concerns about compliance with local legislation and initiating an investigation.
Goodenowe defended his actions by claiming that ProdromeNeuro is a natural dietary supplement and does not require an IND. However, the FDA disagreed, asserting that using ProdromeNeuro to treat dementia patients classified it as a drug, requiring regulatory approval.
Despite these challenges, Goodenowe continues to expand his business ventures into China and Japan, aiming to distribute his supplements in these markets.
The ongoing investigations and regulatory issues surrounding Goodenowe emphasize the importance of adherence to research protocols and regulatory standards in the healthcare industry.