The mouthguard company Brain-Pad Inc. never claimed that its products prevent concussions. Instead, advertisements have long promised that the devices can "reduce the risk" of a head injury and create "brain safety space."
But even these nuanced assertions are unproven and misleading to consumers, according to the Federal Trade Commission, which last month began cracking down on false health claims made by companies marketing concussion safety products.
In a recent settlement with the FTC, Brain-Pad President and CEO Joseph Manzo essentially agreed to remove references to concussions from all packaging and marketing material. Brain-Pad and Manzo are barred from making unsupported claims that the mouthguards reduce the risk of concussion from lower jaw impacts or can decrease the chance of a head injury in general.
The August agreement also prohibits Brain-Pad and Manzo from misrepresenting the health benefits of any mouthguard or other athletic equipment designed to protect the brain from injury. The FTC would not comment on whether the company name, which alludes to brain protection, was an issue.
The heightened concern over the long-term dangers of repeated traumatic head injuries has spawned a thriving industry of concussion-related safety products, from "intelligent" chin straps and mouthguards to high-tech helmets and "neuroprotective" sports drinks. But experts stress that no product — including helmets and mouthguards — can prevent the brain from slamming into the skull after an impact.
"Concussions occur not as a result of the forces experienced by the skull but by those experienced by the brain," said University of Michigan neurologist Jeffrey Kutcher, head of the sports neurology section of the American Academy of Neurology.
Meanwhile, there is little published data to support claims by companies that their products can curb the risk of a concussion or speed healing once one has occurred.
A mouthguard is an essential piece of equipment for athletes who want to protect against bruises, lacerated lips and cracked or broken teeth. It can also reduce some impact to the jaw.
"But it's a big leap to say these devices also reduce the risk of concussions," said David Vladeck, director of the FTC's Bureau of Consumer Protection.
"We don't think it's a 'big leap,'" Manzo countered in a phone interview. Pennsylvania-based Brain-Pad disagrees with the FTC charges, "but we can't afford to fight a lengthy battle so we backed off," he said.
Unlike single-arch mouthguards that offer protection for either the upper or lower teeth, Brain-Pad's mouthpieces, which cost between $8 and $35, fit on both the upper and lower jaw. According to Brain-Pad, the dual-arch mouthpiece repositions and secures the lower jaw down and slightly forward and locks it into a safe position.
"The theory is that a properly placed mouthguard would provide separation and cushioning" by opening up the joint, said Jason Mihalik, co-director of the Matthew A. Gfeller Sport-Related Traumatic Brain Injury Research Center at the University of North Carolina. "There could be a greater amount of space where the force can be dissipated, less bone-on-bone contact, less force transmitted to the brain and decreased risk of injury."
But epidemiological studies to prove that haven't been done, Mihalik said. In addition, very few impacts are directed to the jaw. "The large majority of impacts (in football) are to areas outside the jaw, including face, back, sides and the top of the head," he said.
Brain-Pad has been claiming that its mouthguards reduce the risk of concussions for more than a decade. In 2004, at the request of competitor Shock Doctor Inc., the National Advertising Division of the Council of Better Business Bureaus reviewed the company's assertions.
In a 31-page decision, the division ruled that evidence was sufficient to support Brain-Pad's narrow claim that the products "reduce the risk of lower-jaw impact concussions."
But the division recommended that the company drop or reword a host of other statements, including that the mouthguards "drastically" reduce the risk of head injury and that the product was "endorsed and recommended in over 200 countries by sports organizations, associations and athletes around the world."
Then at a Senate hearing in October, U.S. Sen. Tom Udall, D-N.M., held up a Brain-Pad mouthguard as an example of a concussion-related product being marketed through dubious health claims.
Concerned that some companies are "taking advantage of the (concussion) fears of parents, coaches and athletes," Udall has introduced legislation that would require football helmets to meet safety standards. It would also increase potential penalties for manufacturers that use false injury-prevention claims to sell helmets and other sports equipment.
"The potential harm ... is far more than simply the financial harm of paying more for something that isn't likely to work as claimed," Kutcher testified at the hearing, which focused on the marketing of sports equipment as "anti-concussion" or "concussion reducing." "It is the harm that comes from having a false sense of security, from not understanding how the injury occurs, and what can actually be done to prevent it."
Manzo said he was "in shock" when he saw a video of Udall making fun of his product. "We were never even asked to attend the hearing or asked for our data," he said. "And we've been fighting for 20 years for ... standards. Mouthguards are the only piece of gear that we mandate kids wear that have no standards at all."
Brain-Pad worked with the FTC for months before voluntarily changing its packaging to say the jaw-joint protector is "proven to reduce impact to the base of the skull and TMJ."
"We took the word 'concussion' out of the conversation," Manzo said. "There are plenty of injury prevention qualities that we can use."
Teams and athletes, meanwhile, are left to make their own decisions about the value of the mouthguards. The men's lacrosse team at McGill University in Montreal initially tried the Brain Pad 3XS jaw-joint protectors last season with the hope of reducing concussions, said head coach Tim Murdoch.
Despite the FTC's ruling, the team plans to give athletes the option of using the mouthguards this fall, Murdoch said. "We have no empirical evidence they reduced concussions, but they've had a positive effect on the team," he said. "I do think they are a good product. We're just trying to give athletes the best protection we can."
A player's teeth, at the very least, are likely to benefit. Published literature heavily supports the use of mouthguards to prevent dental injuries.
"It becomes a question of, what is the product designed to do?" Mihalik said. "What can you claim it can do? From a parent's standpoint, I think protecting a $3,000 investment in a child's braces is important."