FDA warns ‘Dr. Goodenowe’ health centre founder that his recent supplement study put patient health at risk

The U.S. Food and Drug Administration (FDA) has rebuked the founder of Moose Jaw, Sask.’s controversial Dr. Goodenowe Restorative Health Center, alleging that a recent clinical trial of his supplements put the safety and welfare of research subjects at risk.

On Jan. 20, the FDA publicly posted a warning letter to Dayan Goodenowe and his company Prodrome Sciences USA, LLC, which manufactures pills and oils that he has claimed can help stop and reverse the progression of diseases like ALS, Alzheimer’s and Autism.

The FDA says that between 2020 and 2021, Goodenowe enrolled 29 people in a clinical trial evaluating whether his product, ProdromeNeuro, was safe and tolerable for patients with mild to moderate dementia.

The study, 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.

While the warning letter does say the study put patient health at risk, it does not suggest any of the subjects actually suffered adverse outcomes.

This is just the latest in a series of conflicts Goodenowe has found himself in the midst of. Last year, he was the subject of several CBC stories and is now under investigation by Moose Jaw police and Saskatchewan’s consumer affairs regulator.

The FDA, which began its investigation in December 2024, said Goodenowe broke the rules by failing to file an Investigational New Drug (IND) application with the FDA before beginning the study. 

In an IND, researchers are required to provide the FDA with documentation — including animal testing data — showing the proposed study won’t expose subjects to unnecessary risks. It also details the ingredients of the drug and how it’s made. 

The FDA's warning letter said Prodrome Sciences' failure to submit that information "raises significant concerns about the safety and welfare of enrolled subjects,” adding that fact “raises concerns about the validity and integrity of the data collected during the conduct of this clinical investigation.” 

A few days after that letter appeared on the FDA’s website, the Frontiers journal posted a correction on the article, flagging it with an “expression of concern.”

“With this notice, Frontiers states its awareness of serious concerns regarding the compliance with local legislation in relation to the article,” says an editor’s note. “Our Research Integrity team is conducting an investigation in full accordance with our procedures.”

Research ethics expert Janice Parente says when researchers fail to follow the rules, patients are put at risk without their knowledge. 

“They’re under the impression that because doctors are running the trial, that it’s all on the up and up,” said Parente, author of Ethics on Trial: Protecting Humans in Canada’s Broken Research System. 

She said by missing this crucial step, Goodenowe was essentially regulating himself.