FDA Issues Warning to Supplement Developer Over Patient Safety

The U.S. Food and Drug Administration (FDA) has issued a warning to Dayan Goodenowe, founder of the Dr. Goodenowe Restorative Health Center in Moose Jaw, Saskatchewan. The agency alleges that a recent clinical trial involving his supplements jeopardized the health and safety of research participants. On January 20, 2025, the FDA publicly released a warning letter directed at Goodenowe and his company, Prodrome Sciences USA, LLC, which produces supplements claiming to halt or reverse diseases such as ALS and Alzheimer’s.

The FDA’s investigation, initiated in December 2024, centered on a clinical trial conducted between 2020 and 2021. This study assessed the safety and tolerability of Goodenowe’s product, ProdromeNeuro, among 29 individuals diagnosed with mild to moderate dementia. The trial’s findings were published in the journal Frontiers in Cell and Developmental Biology in 2022. While the FDA’s letter emphasizes that the study posed risks to patient health, it clarifies that there were no reported adverse outcomes among participants.

FDA Raises Concerns Over Regulatory Compliance

The FDA’s letter indicated that Goodenowe failed to submit an Investigational New Drug (IND) application prior to commencing the study. Such an application is required to demonstrate that the proposed study will not expose subjects to unnecessary risks and includes detailed information about the drug’s ingredients and manufacturing processes. The FDA stated that Prodrome Sciences’ non-compliance “raises significant concerns about the safety and welfare of enrolled subjects” and casts doubt on the “validity and integrity of the data collected during the investigation.”

In response to the FDA’s warnings, the Frontiers journal added an “expression of concern” to Goodenowe’s published study, noting that the journal’s Research Integrity team is conducting an investigation regarding compliance with local legislation. Research ethics expert Janice Parente commented on the implications of such oversight, stressing that patients are often unaware of the risks associated with non-compliant studies, as they operate under the assumption that trials are conducted ethically.

Goodenowe acknowledged the situation in an email, attributing the issue to a “miscommunication” that he believes will be resolved soon. Despite the controversy, he has announced plans to expand his operations into China and Japan.

Ongoing Investigations and Controversies

This warning is part of a broader scrutiny surrounding Goodenowe’s claims and practices. In 2024, several investigations by CBC highlighted concerns about the efficacy of his supplements. Some patients, including an American ALS patient who paid $75,000 USD for a three-month program at the health center, reported worsening symptoms while under Goodenowe’s care. Tragically, this patient passed away in December 2024.

Goodenowe maintains that there are no scientific studies supporting some of his claims, yet he references anecdotal evidence from clients who assert they experienced improvements while using his products. Following these revelations, the provincial government called for investigations by the College of Physicians and Surgeons and Saskatchewan’s consumer protection authority, while the Moose Jaw Police Service opened a criminal investigation due to a complaint from the Opposition NDP.

In his defense, Goodenowe has filed a defamation lawsuit against CBC, alleging that unfavorable media coverage is part of a conspiracy involving the ALS drug industry to undermine his business.

Regulatory experts have weighed in on the implications of Goodenowe’s situation. Timothy Caulfield, a law professor at the University of Alberta, emphasized that FDA warning letters serve as significant alerts to regulators and medical professionals. He suggested that Canadian regulators should take note of the FDA’s actions and consider the potential risks associated with Goodenowe’s practices.

Despite the spotlight on his controversial methods, Goodenowe has ambitious plans. In April, he announced a $100 million investment in a community health project in Moose Jaw, which he claims will provide free access to advanced health services for local residents. He has also established partnerships aimed at expanding his supplement distribution in Asia, including plans to manufacture his products in Canada.

As Goodenowe navigates these challenges, the FDA’s warning underscores the critical importance of regulatory compliance in clinical research, particularly when patient safety is at stake. The outcome of ongoing investigations may have lasting implications for both Goodenowe and the broader field of health supplement research.