In a settlement reached with the U.S. Federal Trade Commission (FTC), Brain-Pad and its president, Joseph Manzo, have been barred from making unsupported claims that the company's mouthguards reduce the risk of concussions from lower jaw impacts, reduce the risk of concussions generally, or have been clinically proven to do either. Brain-Pad denied the charges and stands behind its product but has altered its packaging in recent months to avoid a protracted legal battle.

The settlement 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.

According to the FTC, Brain-Pad and Manzo made their claims about the mouthguards' concussion-protecting qualities on product packaging and in Internet and print advertisements. On packaging for the Brain-Pad Pro-Plus Junior mouthguard, the defendants claimed the device “creates new brain safety space!” and “Reduces Risk of Concussions! From Lower Jaw Impacts.”

Similarly, packaging for the adult-size Brain-Pad Double Mouth Guard proclaims that the device, “Reduces risk of CONCUSSIONS! Protects Upper AND Lower Teeth!”

Mouthguards can help to shield a person's teeth from being injured, and some can reduce impact to the lower jaw, according to David Vladeck, director of the FTC's Bureau of Consumer Protection. “But it's a big leap to say these devices can also reduce the risk of concussions,” he stated in an FTC press release. “The scientific evidence to make that claim just isn't adequate.”

The FTC will publish a description of the consent agreement package in the Federal Register. The settlement agreement will be subject to public comment for 30 days, August 16 through September 17, 2012, after which the FTC will decide whether to make the proposed consent order final. Interested parties can submit written comments electronically or in paper form.

In a statement, Brain-Pad said the company and the FTC have been working together for months, and in that time, Brain-Pad has voluntarily altered its packaging and advertising claims to reflect the parties’ agreement. Brain-Pad believes in its products' ability to help reduce the risk of jaw impact concussions and has worked, and will continue to work, to analyze the science and support behind its products. There is much scientific debate over how best to reduce the risk of concussions across a wide variety of sports.

“As Brain-Pad made clear to the FTC, Brain-Pad does not claim, nor can anyone claim, that their protective devices prevent concussions. It is clear concussions occur under a varied set of circumstances and conditions,” the company said, “Brain-Pad is, however, confident that the claims that it does make about its products are true, where many of its business competitors have no science and no technology behind their claims. Brain-Pad is proud to do its part, both now and in the future, to help improve the sports environment, through education and protection, for youth and professional athletes.”

“Though Brain-Pad remains confident that its science and independent testing and research supports all of its prior claims, and Brain-Pad disagrees with the FTC, Brain-Pad believes that it is better to work with the regulating bodies’ in advancing the protection from injury as science and consumer knowledge continues to develop. Accordingly, despite its disagreement with the FTC’s allegations, Brain-Pad has agreed to modify its advertising to avoid a protracted legal battle and to further this collective goal. Thus, Brain-Pad has agreed to settle with the FTC. Settling does not mean Brain-Pad agrees with the FTC’s allegations; we do not.”

The company concluded that with debilitating injuries on the minds of all coaches and parents, the only acceptable result is that protective sports equipment must bring about a reduction of velocity impact forces.

“We have, in our scientific community, a great understanding of linear impact forces, which were greatly aided by the auto industry’s crash-test programs. However, lateral, angular and rotational forces are not understood as well. Current helmet testing protocols and equipment date from the late 1960s and should be updated to observe more than just skull fractures. It is time for athletes, coaches, trainers, sports medicine doctors, sports equipment manufacturers, regulating agencies, and state and federal governments to work together to understand the potential causes and detrimental effects of all injuries and to establish realistic standards of design to reduce, as much as possible, the incidence of injuries. Brain-Pad firmly believes the steps it has taken in tandem with the Federal Trade Commission review are steps in the right direction.”