With sports equipment hinting -- and sometimes claiming outright -- that their products can prevent concussions, U.S. Sen. Tom Udall (D-N.M.) is pressing the Federal Trade Commission (FTC) to be more vigilant monitoring these claims.
Last week, Udall asked FTC chairwoman Edith Ramirez to examine marketing claims made by the company , the official mouthguard of NFL-backed USA Football, which had on its website: "Absorbs shock to help protect against brain concussions.... Shock absorbing jaw pads help protect against concussions," read ads that the company has since removed.
Udall's request followed a letter he and Sen. Bill Nelson (D-Fla.) asking FTC to investigate companies making alleged false claims about their headgear's ability to prevent or mitigate head injuries in soccer.
In 2014 FTC warned five major retailers to address claims made by mouthguards they carried. And before that, FTC warned 18 companies about mouthguard claims, to stop its mouthguard claims, and settled similar charges against helmet manufacturer Riddell.
The process has frustrated Udall, who has previously said , and accused some in the industry, without naming specific companies, of making false marketing claims. "It is past time to put an end to these dangerous 'anti concussion' marketing claims for youth sports gear," he said in a Senate Commerce Committee hearing Sept. 27.
Ramirez responded to Udall: "I assure you that we will take a very close look." FTC could not confirm nor comment on the headgear or Shock Doctor investigations, spokesman Mitchell Katz said, because they are not public information. "We take all of these requests seriously," he said.
An FTC assistant director in 2014: "The Commission plans to continue monitoring the market for products making these claims, to ensure that advertisers do not mislead consumers about their products' capabilities or about the science underlying them.
"At the same time, we are mindful of the need to tread carefully, so as to avoid inadvertently chilling research or impeding the development of new technologies and products that truly do provide concussion protection."
Hard Evidence Lacking
Up to now, have found little or no evidence that , soccer headgear, or other protective equipment prevent concussion, a recent review found.
"Existing prospective trials show no difference in the relative risk of concussion in athletes wearing novel protective equipment relative to athletes wearing standard equipment," a team led by , of Cincinnati Children's Hospital Medical Center published in the British Journal of Sports Medicine in June. They added: "It is necessary to evaluate other modalities to identify more optimal prevention strategies."
"Protective equipment, including headgear, helmets, mouthguards and face shields, may play roles in reducing the incidence of concussion," Myer and colleagues wrote, "but evidence from existing prospective studies indicates that the preventative effects of these items as a group may be limited."
Regarding mouthguards specifically, they added: "The use of mouthguards in combination with helmets in sports such as football, where helmet use is already the norm, begs the question as to whether mouthguards (and consequently, mouthguard type) are even relevant for concussion prevention strategies. A need exists for closer and more rigorous examination of the mouthguard as a concussion prevention tool, with attention paid to mouthguard type and thickness and consideration given to the mechanism of injury in each sport studied."
But Myer and colleagues saved their strongest language for football helmets, saying they "do nothing to mitigate the effect of brain slosh. Therefore, in terms of concussion prevention, football helmet improvements may be reaching a point of diminishing returns and are not likely to be the solution to the concussion issue."
Legislation in Congress
The FTC was instructed to patrol companies' concussion prevention claims Udall included in the omnibus appropriations measure passed in December.
Udall also has co-authored The Youth Sports Concussion Act, which would allow FTC to increase penalties to companies for such claims. the Senate Commerce Committee earlier this year and Udall hopes it will be enacted soon. "It's a reasonable possibility," spokeswoman Jennifer Talhelm said. The bill is supported by organizations including the American Academy of Neurology, American Academy of Pediatrics and Cleveland Clinic -- as well as the NBA and NFL.
Shock Doctor, that , sells more than 5 million mouthguards annually, according to the Orange County (Calif.) Register.
The company declined to speak with MedPage Today. After asking for questions to be emailed, a spokeswoman did not answer them, writing: “In response to your questions, Shock Doctor remains focused on our core mission of educating athletes on the benefits of mouthguards to protect against oral-facial and tooth injury. While that’s all of the information I have to share at this time, certainly appreciate you reaching out.â€
Brain-Pad, meanwhile, now as "reduc[ing] the impact energy entering the TMJ [temporomandibular joint] and base of the skull," as well as a that "reduces impact energy up to 50%." But it does not currently claim a reduction in concussion risk. That “energy†language is based on scientific evidence posted on the company’s website, company CEO Joseph Manzo told MedPage Today.
In 2012, when the FTC charged the company with making false or misleading claims, the agency provided stating explicitly that its products reduce risk of concussions.
Nevertheless, when contacted for this article, Manzo said in an email, "We have never made a claim of concussion prevention in the 20 years I've been with the company. If the FTC and Senator Udall say that no one in the equipment industry can say that their products prevent concussions how can you do a story on concussion prevention equipment?"
Manzo added that his company doesn't "want to give a false impression. All we can do is state the facts and test results and let people make up their own minds. If we don't take a scientific approach nothing will ever improve."