Device claims to protect athletes’ brains, but records reveal doubts at FDA

“The science is real,” McAfee said. “Hopefully this is something that helps the next generation.”

A C-shaped piece of springy metal coated in plastic that retails for $199, the Q-Collar is designed to apply pressure to the jugular veins, based on the theory that restricting the flow of blood from the skull limits how much the brain can jostle. “Like a seatbelt for your brain,” as Q30 puts it.

Since earning Food and Drug Administration clearance in 2021, Q30 has sold tens of thousands of Q-Collars to athletes as young as 13, and has gained supporters in Congress who are trying to steer the Defense Department to consider the device.

But internal FDA documents show that some of the agency’s reviewers doubted Q-Collar research showed the device offered meaningful protection against brain injury, damage or disease. The agency agreed to clear it, the records show, only after Q30 added language to its owner’s manual stating the device does not prevent concussions and that any claims it protects against long-term cognitive problems have “not been demonstrated.”

This language is nowhere to be found in Q30’s promotional materials, raising concerns among some experts in neuroscience and concussion research that the company is exaggerating the device’s proven benefits.

The FDA documents are part of a new peer-reviewed investigation of the Q-Collar published in BMJ, the journal owned by the British Medical Association. The researchers who wrote the BMJ investigation obtained the FDA documents via the Freedom of Information Act and shared the records and their research paper with The Washington Post in advance of publication.

Q30 executives declined interview requests.

“Q30 Innovations is proud of the Q-Collar’s place as the first and only device ever cleared by the FDA to help athletes protect their brains …,” the company wrote in a statement in response to written questions. “The FDA’s medical experts made a thorough evaluation of the data and made the right call on the benefits outweighing the little to no risk of wearing the Q-Collar.”

The BMJ paper, published by two medical researchers, including one longtime critic of the Q-Collar, calls for the FDA to review its decision to clear the device. An FDA spokesperson declined to comment to The Post, citing the government shutdown.

This summer, an FDA spokesperson did reply to BMJ for its investigation.

“The clinical study data reviewed by the FDA supported the safety and effectiveness of this device as an aid in the protection of the brain from effects associated with repetitive sub-concussive head impacts. The data do not demonstrate that the device can prevent concussion or serious brain injury,” the spokesperson wrote.

It isn’t unusual for the FDA to sign off on a new medical device with ambiguous evidence that it works.

But those devices must be marketed and promoted with language that doesn’t exaggerate or overstate the device’s limitations in labels the FDA approves.

In promotional materials on its website and YouTube channel, Q30 and its executives repeatedly state that the device is proven to protect the brain from injuries and may even prevent long-term damage and disease.

“We reduce injury caused by repetitive subconcussive impacts,” Q30 chief executive Tom Hoey said in a recent video ad. “That could be what’s going to minimize these longer term health conditions, whether it’s dementia, whether it’s CTE,” he said, referring to a neurodegenerative disease linked to head trauma and football.

Q30, in its statement to The Post, defended its marketing as “consistent with the letter and spirit of the law.”

Customer reviews highlighted on Q30’s website suggest that wearing the device has given some athletes a greater sense of comfort, despite any uncertainty over its actual benefits.

“After the concussion my son received this year, he was kind of scared getting back into football,” reads one review. “But knowing that he had the Q-Collar on his neck he felt safe and secure.”

After coming up with the idea, Smith connected with Hoey, a sporting goods manufacturing executive, who decided to co-found Q30, based in Westport, Conn., and make the Q-Collar the company’s signature product.

When Q30 executives began touring the country in the early 2010s, seeking investors and interest in their product, they had a compelling sales pitch: a concussion-prevention device inspired by, of all things, the woodpecker.

“Why doesn’t a woodpecker get a concussion?” Jamison Float, Q30’s vice president of innovation, told the Columbus Dispatch in 2015. “It was that little seed of thought that led to Dr. Dave basically spending a year of his life, and immersing himself in the physiology of the woodpecker.”

A woodpecker can hammer its head into trees millions of times without suffering brain injuries, Float explained, because it naturally restricts its jugular vein, filling its skull with just enough blood to serve as a natural cushion.

“What if we do the same thing the woodpecker does?” Float told the Dispatch, before slipping a Q-Collar around his neck.

“Everybody is so caught up in their own research, nobody has the time, even if they agree something doesn’t sound right, to devote to trying to debunk it,” said Smoliga, who now works in Tufts University’s physical therapy program, in an interview. “I did.”

In 2018, Smoliga collaborated with Lizhen Wang, a woodpecker researcher from China, on an editorial in the British Journal of Sports Medicine that argued Q30 executives were misrepresenting the bird’s physiology.

Several characteristics protect the woodpecker against brain damage, Smoliga and Wang wrote, including a spongy bone structure in the skull and a beak that dissipates shock. But they were unable to find any support in published research for Q30’s theory the bird compresses its jugular veins to fill its skull with blood.

“There is a lot of research on woodpeckers, and we couldn’t find it anywhere,” Smoliga said. “The only people who have proposed it are associated with the Q-Collar.”

Q30 and its executives, who used to mention the woodpecker routinely in interviews and on social media, appear to have dropped references to the bird from Q-Collar promotional materials.

Smith, the inventor, acknowledged in an interview with The Post that he never studied woodpeckers or reviewed published research on them. Looking at photos of the bird and its bone structure online, he said, led him to develop a theory that humans could protect their brains from damage by restricting their jugular veins.

“I’m not a woodpecker veterinarian,” Smith said. “I am someone who understands physiology.”

Q30, in its response, dismissed concerns over woodpecker physiology as irrelevant to current disputes about the Q-Collar and its benefits.

“Whatever inspired the inventor’s creativity, the safety and effectiveness of the Q-Collar was proven by years of research and development,” the company wrote.

From 2014 through 2018, Q30 funded several clinical trials examining the Q-Collar’s safety and effectiveness on high school athletes playing football, ice hockey and soccer.

Instead of focusing on if the Q-Collar prevented concussions, these studies examined differences between the brains of subjects who wore the Q-Collar and those who didn’t, through a type of brain scan and analysis called diffusion tensor imaging, or DTI, which measures how water moves through the brain’s white matter.

“The term ‘concussion’ is confusing for everyone. There just isn’t a universal definition …,” wrote Olan, a neurosurgeon and associate professor at George Washington University School of Medicine. “DTI can show clear images of changes to the brain. … If the brain scans of two football teams showed changes in white matter from the team without the collar and no, little or just less change in the team with the collar, I’d rather see players wearing the collar than not.”

But other brain imaging experts interviewed by The Post emphasized that there is little consensus in the field over how DTI results connect to actual brain injury, including the type of subconcussive injuries thought to lead to later life problems like dementia and CTE.

Talavage, the head of the biomedical engineering department at the University of Cincinnati, has led his own studies of high school football players using DTI, documenting what he and others think were signs of brain inflammation caused by repetitive subconcussive hits.

As he reviewed Q30’s research, Talavage said, he came to believe the device offered some protection.

“The athletes who had worn the Q-Collar … still showed some evidence of inflammation, but … it was meaningfully less than the athletes who had not worn the Q-Collar,” Talavage said. “I think the collar is doing something, and it’s probably doing something that is good. … But I would not say it is proven to protect the brain from injury.”

Other experts were even more skeptical.

Because there was no similar device on the market, Q30 needed to put it through the FDA’s “de novo” clearance process, for devices with low to moderate risk, to sell it in the United States. While drugmakers have to show convincing evidence that a new prescription drug is effective to win the agency’s blessing, Q30 had to show only that the benefits of its device likely outweighed the risks, which the FDA classified as moderate.

In 2024, Smoliga submitted a FOIA request to the FDA, seeking all documents relating to its decision to clear the Q-Collar. Earlier this year, the agency released to him nearly 6,000 pages of heavily redacted memos that show the FDA reviewers had the same concerns about DTI results expressed by Q-Collar critics.

“I recommend this de novo be declined due to the lack of evidence of effectiveness,” FDA statistician Xuefeng Li wrote in a December 2020 memo.

A February 2021 memo shows other reviewers, including the FDA’s expert on medical imaging, had also shared doubts.

“The medical imaging expert states that DTI imaging may not exhibit clinically meaningful results,” the memo states. “… Overall, the team still feels uncertain about the clinical meaningfulness of DTI imaging.”

But others on the team of eight reviewers found the Q-Collar research compelling.

Christopher Loftus, a neurosurgeon on the review team, concluded, “there is evidence of clinical benefit,” according to the February 2021 memo.

The FDA decided to clear it, but pointedly listed its doubts in its clearance document: the study results were uncertain; the link between the key data and brain function was unclear; the evidence only predicted a benefit, rather than showing a clinical effect in athletes.

“Given the urgent need for protection of the brain following mild head impacts,” the document states, “the probable benefits outweigh the probable risks.”

The agency worked with Q30, documents show, to “update the labeling to mitigate specific areas of uncertainty.” This labeling, which the FDA required in the Q-Collar owner’s manual, included the following statements: “The Q-Collar has not been demonstrated to prevent long-term cognitive function deficits, and the ultimate impact on clinical outcomes has not been evaluated. … Data do not demonstrate that the device can prevent concussion or serious brain injury.”

The FDA’s news release announcing the decision was worded cautiously, stating that the Q-Collar “may reduce the occurrence of specific changes in the brain that are associated with brain injury.”

Q30, on its website, touts the FDA sign-off with a less vague summary of what Q-Collar research has found.

“FDA-cleared and proven to help protect the brain from impacts during sports,” the website states.

Q30’s website contains a wealth of information about the Q-Collar, including a section under the heading “What it doesn’t do.”

The bullet points underneath assure potential buyers that the Q-Collar does not negatively impact athletic performance, or reduce blood flow through the carotid arteries.

There are no warnings, however, that the device has not been shown to prevent concussions. Nor is there a warning that any claims it prevents longer-term cognitive problems and disease have not been proven.

The company’s executives and NFL ambassadors offer no such caveats, either.

“The Q-Collar gives me an extra, added layer of protection. … It keeps my head in the game,” says Tennessee Titans running back Tony Pollard in a video ad titled “Protect Your Future.”

“The Q-Collar is the first and only device that protects from these subconcussive injuries,” says Wayne Olan, the GWU neurosurgeon and Q30 medical adviser, in one video ad. “There is no real question anymore — [t]he athletes who are making this a part of their protective gear are more protected.”

“The FDA officially cleared the device. … This clearance means that number one, the device is safe for you to wear, but number two, it’s proven effective,” says Suzanne Williams, Q30 vice president of sports marketing, in another.

Two former FDA officials who reviewed the Q-Collar materials offered differing assessments to The Post about whether the company’s marketing is exceeding what the FDA permitted it to say.

“Essentially [the FDA] is saying, ‘We have no idea if it works,’” said Alberto Gutierrez, who spent 25 years regulating devices at the FDA before leaving the agency in 2017.

Gutierrez said the FDA should have followed up to ensure that the Q-Collar was marketed in line with the limitations on its label. “The webpages tell me they have not,” he said.

But Lowell Schiller, a former senior FDA official who consults on regulatory policy, said the agency’s clearance was complicated and vague, and left Q30 marketers with a difficult task.

“How that gets translated to language a consumer can understand, while also not overstepping the limitations, is challenging,” he said.

Q30 also highlights customer reviews on the website, under the heading “Real Customers, Real Reviews.”

Several of them describe parents feeling reassured that their children, who suffered concussions, could safely return to contact sports.

“My son’s first year wearing for football as a 120lb sophomore with previous concussions. It makes a dramatic impact on his self-confidence knowing he’s protected,” reads one.

“Incredibly revolutionary product,” reads another. “Purchased for my son who had a concussion with a brain bleed that required surgery from onfiled (sic) contact.”

Chris Nowinski, chief executive of the Concussion Legacy Foundation and an advocate for prohibiting tackle football under age 14 due to risks including CTE, found these reviews both alarming and tragic.

“These appear to be parents who are concerned about the long-term risks … and the Q-Collar is the reason why their kids are still playing,” said Nowinski, who noted that research has consistently found the risk of developing CTE is associated with how long someone plays a contact sport, not the number of concussions.

Q30 dismissed this concern in its statement to The Post.

“Our customer feedback includes scores of parents who consulted their doctor about using the Q-Collar. Critics out there guessing about how decisions are being made are just making assumptions,” the company wrote.

Q30 has gained two powerful supporters from its home state, in Connecticut’s two senators, both Democrats.

In an April 2024 news release, Sen. Chris Murphy praised Q30 and said he had “helped secure over $15 million in federal investment through the Department of Defense to support Q30.” Murphy’s office did not reply to repeated requests for more information about the funding.

And last October, Sen. Richard Blumenthal told a Connecticut television station that he was “pressing the Department of Defense to consider using this device on the battlefield and in training wherever it can save our military men and women from the concussive impacts.”

Blumenthal’s office declined to comment on these efforts. A spokesperson for the Defense Department also declined to answer questions regarding any money it has given Q30, which has spent $720,000 over the last five years on lobbying and consultants, according to an analysis of lobbying disclosure reports by the nonprofit OpenSecrets.

Q30 has developed a product specifically for military and law enforcement called Q-Collar Tactical. It comes in black and camouflage, and retails for $249. (Q30 declined to answer why the tactical model is more expensive.)

Four years after the FDA authorization, Q-Collar hasn’t seen sales skyrocket to the degree its top executives expected, according to a story last October in the Milwaukee Business Journal.

Q30 expected to sell hundreds of thousands of collars in just the first year after getting FDA clearance, according to the story, which was based on an interview with a Q30 manufacturing partner. In 2024, this partner said, Q30 sold about 50,000 collars.

But the manufacturer remained optimistic about future sales, in part, because of recent events that again had highlighted the risks of head trauma in sports: Miami Dolphins quarterback Tua Tagovailoa’s repeated concussions and legendary quarterback Brett Favre’s announcement that he was battling Parkinson’s disease.

And the company has earned some repeat customers, including Richard Deems, head football coach at Peyton High School outside Colorado Springs.

This season is the third in which Deems’s entire team wears Q-Collars.

“Since we’ve implemented the use of Q-collars, our concussions per season have probably dropped from 3 to 5 per season to 0 to 1,” he said.

Told about the debate over Q-Collar research, and the company’s own admission the device doesn’t prevent concussions, Deems acknowledged the possibility of a placebo effect.

“But personally, I’m a believer,” he said, offering what he found a compelling anecdote.

“I’ve seen kids get lit up and hop right back up, wearing a Q-Collar,” he said. “In the past, that kid would’ve been messed up.”