As football season gets under way, the news is filled with stories about the toll concussions suffered by players can take on the brain, and even the Center for Disease Control has offered advice on the subject.  Last month the FTC announced a complaint and settlement with a marketer that promised that its mouthguard could reduce the risk of sports-related concussions.  The FTC announced the proposed settlement with Brain-Pad, Inc. and its President Joseph Manzo that bars the defendants from misrepresenting the health benefits of mouthguards or other athletic equipment designed to protect the brain from injury. Following the settlement, Brain-Pad cannot make unsupported claims that its 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’s ads claimed the mouthguard “creates new brain safety space!” and “reduces risk of concussions from lower jaw impacts!” by opening an airway when an athlete has his or her teeth clenched.  The packaging also touted the device as being “tested and proven to reduce risk of internal head injuries and concussions from lower jaw impacts” and “biochemically tested & proven!”

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The FTC looked at Brain-Pad’s testing for the mouthguard and concluded that the company did not have competent and reliable scientific evidence to support its health claims.  The FTC noted that even though the product can help protect an athlete’s teeth and maybe even reduce impact to the lower jaw, the FTC described it as “a big leap” to claim that the device also reduces the risk of concussions.

Simultaneous with its announcement of the settlement, the FTC also released guidance for marketers on sports concussion prevention claims.  The agency warns that even though brain injuries have become a serious concern for parents, players and coaches alike, a marketer or advertiser must be able to back up all of their promises with competent and reliable evidence to substantiate any prevention or reduction claims. Unlike in Iovate and Reebok, the FTC did not specify the number or type of testing required to constitute competent and reliable scientific evidence, and this probably is due to the difficulty of conducting controlled testing on this type of claim.  The FTC’s enforcement action is consistent with its effort to closely scrutinize advertising impacting children and claims involving health and safety.