The founder of the Dr. Goodenowe Restorative Health Center in Moose Jaw, Saskatchewan, Dayan Goodenowe, and his company, Prodrome Sciences USA, LLC, have received a warning letter from the U.S. Food and Drug Administration (FDA). The FDA criticized Goodenowe for conducting a clinical trial on his supplements that jeopardized the safety and well-being of the participants. The trial, which took place between 2020 and 2021, involved 29 individuals testing the product, ProdromeNeuro, for patients with mild to moderate dementia.
The FDA highlighted that Goodenowe failed to submit an Investigational New Drug (IND) application, which is required to ensure the safety and validity of clinical trials. The warning letter expressed concerns about the potential risks posed to the study participants and the integrity of the data collected during the research. Despite these findings, the letter did not report any adverse outcomes experienced by the subjects.
This latest development adds to the ongoing controversies surrounding Goodenowe. Last year, he faced scrutiny from various sources, including CBC reports and investigations by Moose Jaw police and Saskatchewan’s consumer affairs regulator. The FDA initiated its investigation in December 2024, revealing Goodenowe’s non-compliance with regulatory requirements.
In response to the warning letter, Goodenowe stated that the issue stemmed from a miscommunication and assured that it would be resolved promptly. However, the FDA emphasized the seriousness of the violations and the need for comprehensive corrective measures to prevent similar incidents in the future.
Despite these challenges, Goodenowe remains determined to expand his operations, with plans to enter the Chinese and Japanese markets. His ambitious initiatives include establishing a network of health facilities and centers in these countries. However, regulatory authorities, such as Health Canada, have cautioned that Goodenowe must adhere to licensing requirements and regulations before manufacturing and distributing his supplements in Canada.
The FDA’s actions have raised concerns among experts and regulators, emphasizing the importance of compliance with research protocols and ethical standards in medical studies. The repercussions of Goodenowe’s actions serve as a cautionary tale for researchers and highlight the need for stringent oversight in the healthcare industry.