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 conditions 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. 

“You’ve lost an entire structure. You’re working in a structure that you’ve created yourself,” she explained. 

CBC asked Goodenowe for comment. In an email, he said it’s all based on a miscommunication that will “be resolved in the near future,” though he didn’t explain the nature of that miscommunication or how it will be resolved. 

This conflict is not slowing down Goodenowe’s plans. Over the past few months he has announced he’s expanding into China and Japan. 

This is just the latest drama surrounding Goodenowe, 57, and his companies. 

Last year, a series of CBC investigations raised questions about claims Goodenowe has made regarding the effectiveness of his supplements. 

American ALS patients paid Goodenowe $75,000 US to attend his three-month live-in program on the promise that the Dr. Goodenowe Restorative Health Center in Moose Jaw, Sask. had “a 100 per cent success rate in stopping the progression and in restoring function of people with ALS.”

Several of those patients or their families told CBC that ALS symptoms continued to worsen while in the program and afterward, despite the fact Goodenowe told CBC that every client “leave(s) that centre better than they came in.”

Goodenowe has acknowledged there are no scientific studies backing up his ALS claims but he does point to anecdotes, testimonials of his clients who have reported improvements while on the supplements. 

After CBC’s Nov. 30 story, the provincial government called for investigations by the College of Physicians and Surgeons and Saskatchewan’s consumer protection authority. In addition, the Moose Jaw Police Service launched a criminal investigation after a complaint by the Opposition NDP. 

Goodenowe sued CBC for its reporting, alleging it is defamatory. He said CBC was publishing untruths as part of what he believes may be a conspiracy with the ALS drug industry, the ALS association and the NDP to undermine his business, which he says is seen as “a direct threat to the ALS drug industry.”   

In Goodenowe’s Targeted Plasmalogen Supplementation study, researchers reported that after four months of taking Goodenowe’s ProdromeNeuro, the majority of the participating dementia patients experienced improved mobility and a minority “displayed significant cognitive improvement.”  

“The success of the ProdromeNeuro trial marks a significant step in Alzheimer’s research, with potential implications for other diseases such as Parkinson’s, multiple sclerosis, and autism,” Goodenowe concluded in a July 2022 post on his website. 

In speaking of the study in an August 2022 interview on YouTuber Brian Crombie’s channel, Goodenowe said “the people that were the most severely cognitively impaired benefited the most,” adding “we do believe that we can rebuild human brains. There’s no reason why you can’t turn a raisin back into a grape.” 

According to the warning letter, Goodenowe defended his decision to not file an IND application in correspondence with the FDA. 

He claimed that because ProdromeNeuro is natural — “a blend of naturally occurring alkylglycerols … found naturally in shark liver oil” — it is therefore “a dietary supplement that does not require an IND.” 

The FDA said Goodenowe was mistaken. 

It said that under the law, even natural substances can be deemed drugs if they are being tested in the “diagnosis, cure, mitigation, treatment or prevention of disease.” 

“ProdromeNeuro Oil was intended for use as a drug, not as a dietary supplement,” the FDA said, because Goodenowe was using it to treat patients with mild to moderate dementia in an effort to improve their cognitive and functional abilities.

Following the investigation, Goodenowe took some corrective action, according to the warning letter. 

He told the FDA he hired a consultant to help resolve the conflict with the FDA and to assist his company in complying with the law. In addition, he committed to a comprehensive review of his training programs with a focus on “the differences between clinical studies involving dietary supplements and clinical studies involving investigational drugs.”  

That wasn’t enough to stop the FDA from publicly releasing this warning letter, because, the agency said, Goodenowe’s plan didn’t sufficiently explain how he would prevent similar violations in the future.

In an email to CBC, Goodenowe suggested that the source of the FDA’s concern was not directly his fault. He said that a company he hired to review the ethics and protocol of the study, Sterling IRB, made a mistake. 

“The procedural concern raised by the FDA was missed by [Sterling IRB], which could have been easily fixed at the time,” Goodenowe said. “We are working with the FDA to resolve the issue.” 

CBC asked Goodenowe why, if this matter can be “easily fixed,” he failed to provide this missing information to the FDA at any point during the past year. The regulator first raised the issue of the missing IND with Goodenowe on Jan. 10, 2025 — more than a year ago.  

His Texas-based communications official replied that Goodenowe “has nothing further to add at this time.”

Research ethics expert Janice Parente told CBC Goodenowe is incorrect when he refers to his conflict with the FDA as a “procedural concern.” 

“Conducting research with an unapproved drug on humans without regulatory approval is not a procedural issue — it’s breaking the law,” she said. 

Timothy Caulfield, a law professor at the University of Alberta and internationally recognized expert on policy and ethical issues in medical research, says FDA warning letters are serious matters for researchers and for those tasked with regulating them. 

“I definitely think that this should be a red flag to regulators across Canada about this provider,” he said. 

The Goodenowe centre is a private, unregulated company that operates outside of the medical system. Goodenowe is not a medical doctor and is therefore not regulated by the College of Physicians and Surgeons. 

“I think this should highlight for regulators more broadly that action needs to be taken,” Caulfield said. 

When CBC spoke with Goodenowe last year, he touted his expertise, saying “there’s no one in the world that does more science than I do.” He also said he had “lots of experience with the FDA,” including having submitted IND applications in the past. 

“I interact very extensively with regulatory agencies and I have a very positive relationship with them and I continue to have one,” he said. 

Caulfield said given all of that, he can only think of a couple of possibilities that might help explain why Goodenowe failed to seek the FDA’s approval for his research.

“He was either so naive and so oblivious to the regulatory requirements, or he knew about them and was trying to sidestep them,” said Caulfield. “And for someone who’s positioning himself as a sophisticated researcher … either one of those conclusions is not very complimentary.” 

CBC asked the company behind Frontiers in Cell and Developmental Biology, Frontier, why it published this article, given that the researchers had failed to submit the required regulatory approvals. 

Elena Vicario, director of research integrity for the company, told CBC by email that when the article was published back in 2022, the journal believed all of the required regulatory rules had been followed because the ethics of the study had been reviewed by Sterling IRB.  

“In line with all publishers, we require proof of approval by an IRB who check and verify all regulatory compliance,” said Vicario. “We published the article on the basis that the IRB had checked this regulatory requirement.” 

Sterling IRB did not reply to CBC’s emails when asked for comment. 

Parente told CBC that Frontier’s approach — blaming the IRB — is a cop-out.  

“I think it’s way too easy for anyone to point the finger,” she said. “The onus is on the journal if they want good research published, that it have IRB approval, that it have regulatory approval, and that it be registered. They have to do their due diligence on all three things.” 

Goodenowe is not a medical doctor, so for this study, he partnered with a Dr. Sheldon Jordan, a board certified neurologist based in Santa Monica, California. 

In a joint news release in 2020, Goodenowe and Jordan announced the study, writing “the Regenesis project, a clinical research program led by expert neurologist Dr. Sheldon Jordan, is investigating the ProdromeNeuro oil supplement.” Jordan is listed as a co-author. 

Jordan has not replied to CBC’s emails, but an employee of his company told CBC “I wanted to clarify that Dr. Jordan and our group have not been involved with Dr. Goodenowe or his organization for several years.”

Despite the recent conflict, Goodenowe is pushing forward with his business.  

In April, he announced a $100 million expansion of his operations in Moose Jaw — the Moose Jaw Vitality Project. He says he’s providing “free access to cutting-edge health services and monitoring technologies for all residents of Moose Jaw, Saskatchewan.”

More recently, he announced that he’s also expanding into Japan and China. 

In October, he announced a partnership with a Chinese firm to build “a nationwide Perpetual Health network in China, including 1,000 rehabilitation centers over the next three to five years,” says the news release.

“This ambitious initiative will also include 100 Dr. Goodenowe-branded blood testing and digital brain imaging centers across the country.”

Currently, he is making his Prodrome supplements in the U.S., but he has recently announced plans to start manufacturing them in Canada.