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The Federal Trade Commission testified before Congress this week on actions it has taken to help ensure that concussion protection claims made for football helmets and other sports equipment are truthful and supported by reliable scientific evidence.
Testifying on behalf of the Commission before the House Energy and Commerce Committee’s Subcommittee on Commerce, Manufacturing and Trade, Richard Cleland, Assistant Director for Advertising Practices in FTC’s Bureau of Consumer Protection, outlined the agency’s enforcement efforts. The testimony notes that as awareness of the danger of concussions has grown, manufacturers have started making concussion-protection claims for an increasing array of sports-related products.
“Given the dangers that concussions pose for young athletes engaged in sports, it is essential that advertising for products claiming to reduce the risk of this injury be truthful and substantiated,” the testimony states.
The testimony points out that in August 2012 the Commission announced a settlement with the marketers of the Brain-Pad mouth guard. The Commission alleged that Brain-Pad, Inc. and its president lacked a reasonable basis for their claims that Brain-Pad mouth guards reduced the risk of concussions, especially those caused by lower jaw impacts, and that they had falsely claimed that scientific studies proved that those mouth guards did so. The order in that case prohibits these and other deceptive claims.
In November 2012, after the order in the Brain-Pad case became final, the Commission staff sent out warning letters to 18 other manufacturers of sports equipment, advising them of the Brain-Pad settlement and warning them that they might be making deceptive concussion protection claims for their products, according to the testimony.
The Commission staff also investigated concussion risk reduction claims made by three major manufacturers of football helmets: Riddell Sports Group, Inc., Schutt Sports Inc., and Xenith, LLC. The staff closed the investigations without taking formal action. All three companies discontinued potentially deceptive claims in their advertising, or had agreed to do so, the testimony stated.
The Commission will continue monitoring the market to ensure that advertisers do not mislead consumers about their products’ concussion-protection capabilities, or the science behind them. The Commission’s approach will be balanced, to avoid inadvertently chilling research or impeding development of new technologies and products that truly do provide concussion protection, the testimony concluded.
The Commission vote approving the testimony and its inclusion in the formal record was 4-0.
Sports Brain, a Chicago based-organization concentrating on the implementation of comprehensive concussion baseline testing and concussion management programs to youth, high school, college, and professional sports organizations, will showcase two systems aimed at fighting the concussion crisis at the NFL Combine today and tomorrow at the Indiana Convention Center.
“Having traveled around the country the last few years evaluating different emerging concussion technologies, we believe that these two systems fit in Sports Brain’s model because we can provide these services to many current and former athletes,” said Roy Kessel, Founder of Sports Brain.
The LENS, or Low Energy Neurofeedback System, is a neurofeedback system that uses feedback directly to the skin of the scalp, and requires no visual or conscious feedback. For all individuals, and especially for children, the feedback “produces a measurable change in the brainwaves without conscious effort from the individual receiving the feedback, and does not rely on the therapist conducting the session,” according to Kessel..
“We conducted a pilot study with the NFL Alumni Chapter in Chicago and were able to achieve tremendous improvement for many of the former athletes,” he said. “We are hoping that by exposing more athletes and more of the NFL community to the capability of our system that we will be able to provide tangible relief for many of the current and former NFL players.”
The HeadRehab System is “a comprehensive virtual reality system” that can measure attention, balance, memory, and reaction time. The system can be used as a general baseline test as well as a training system to improve athlete performance.
“HeadRehab is a terrific system which incorporates the latest virtual reality technologies to provide the ability to test athletes in a dynamic environment rather than just sitting a desk with the traditional computerized exams,” said Kessel.
He added that Sports Brain is “very excited to have a strong presence at the NFL Combine this year. Given the nature of the NFL Combine, this is an ideal environment for individual players and stakeholders to understand and learn more about the role baseline testing and performance enhancement can play in their career.”
The non-profit Sports Legacy Institute (www.sportslegacy.org) announced earlier this week “a major advance in the effort to prevent concussions and brain damage in contact sports” with the launch of the Hit Count® certification program after two years of development.
Hit Count® builds on the progress that head sensor device companies have made in developing devices that can measure acceleration of the head. Current products used on the field are focused on alerting coaches, medical professionals, and parents when a potential concussive impact occurs.
Inspired by Pitch Counts baseball, which set limits to the number of times a player throws from the mound to prevent arm injury, Hit Count® Certified Devices will have a second function that measures and “Counts” impacts that exceed the Hit Count® Threshold, set by a committee of leading scientists, with the goal of minimizing brain injury.
“Research using sensor devices has revealed that each year in the United States, there are over 1.5 billion impacts to the heads of youth and high school football players,” said Chris Nowinski, Founding Executive Director of SLI who launched the Hit Count® initiative in 2012 with SLI Medical Director Dr. Robert Cantu. “Most hits are unnecessary and occur in practice. By utilizing Hit Count® certified products as a teaching tool for coaches and a behavior modification tool for athletes, we can eliminate over 500 million head impacts next season.”
Committee member Gerry Gioia, PhD, of Children’s National Medical Center and George Washington University School of Medicine, unveiled that the Hit Count® Threshold will be set at the subconcussive level of 20 g’s of linear acceleration. “This is the beginning of a major research and public health effort to limit brain trauma in sports. While current science does not provide a “safe” or “unsafe” Hit Count®, our goal is to eventually provide clear guidance for coaches and parents. We will need the youth sports, sensor manufacturer, and medical science communities to work together to provide reliable answers.”
Hit Count® Certified products will go through “a rigorous test protocol” developed by the University of Ottawa Neurotrauma Impact Laboratory in conjunction with engineers from the six Hit Count® Initiative sponsors, including Battle Sports Science, G-Force Tracker, i1Biometrics, Impakt Protective, MC10, and Triax.
“Head sensor devices involve complex technology, and many sensors on the market today are not accurate,” said Dr. Blaine Hoshizaki, Director of the Neurotrauma Lab that developed the test, which is open to any company in the space. “Hit Count® Certification, the first and only sensor certification in the marketplace, will give consumer and research scientists the confidence that the sensors are accurately measuring impacts, providing simple and actionable data.”
G-Force Tracker, which is implanted inside football, ice hockey, and lacrosse helmets, is the first company to be Hit Count® Certified, with more products expected to be tested and certified later this year.
The “blue ribbon” consensus committee that set the threshold included Drs. Robert Cantu and Ann McKee of Boston University, Kevin Guskiewicz of the University of North Carolina, David Hovda of UCLA, Gerry Gioia of Children’s National Medical Center, Blain Hoshizaki of the University of Ottawa, William Meehan of Harvard Medical School, and Kelly Sarmiento of the U.S. Centers for Disease Control and Prevention (CDC).