The U.S. Food and Drug Administration (FDA) has criticized the creator of Moose Jaw, Sask.’s controversial Dr. Goodenowe Restorative Health Center, accusing him of endangering research participants in a recent clinical trial of his supplements.
On January 20, the FDA issued a public warning letter to Dayan Goodenowe and Prodrome Sciences USA, LLC, his company that produces pills and oils claiming to address conditions like ALS, Alzheimer’s, and autism.
Between 2020 and 2021, Goodenowe conducted a clinical trial involving 29 individuals to assess the safety and tolerance of his product, ProdromeNeuro, in 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 highlighted the potential risks to patient health, it did not report any adverse incidents among the participants. This incident is the latest in a series of controversies involving Goodenowe, who is currently under investigation by Moose Jaw police and Saskatchewan’s consumer affairs regulator.
The FDA investigation initiated in December 2024 found that Goodenowe failed to submit an Investigational New Drug (IND) application, a prerequisite for conducting clinical trials. An IND application provides the FDA with essential information, including data from animal testing and details about the drug’s ingredients and production process.
Following the FDA’s warning, the Frontiers journal added an “expression of concern” to the article, indicating a review by their Research Integrity team. Goodenowe defended his actions, stating that ProdromeNeuro, being a natural supplement derived from shark liver oil, did not require an IND. However, the FDA disagreed, asserting that the product was being used as a drug to treat dementia and therefore required regulatory approval.
In response to the FDA’s concerns, Goodenowe stated he had hired a consultant to address the issues and committed to enhancing his company’s compliance with regulations. Despite these efforts, the FDA maintained its warning, citing insufficient steps to prevent future violations.
Goodenowe’s expansion plans into China and Japan are proceeding despite the ongoing scrutiny. He faces multiple investigations and lawsuits related to the efficacy of his supplements and his research practices. The FDA’s actions serve as a cautionary signal for regulators and healthcare professionals regarding Goodenowe’s operations.
