Medical Devices and Prescription Drug Policy

FTC bars false safety claims in concussion case

The company Brain-Pad was brought up as making dubious claims about its product at a hearing last year in the Senate Commerce, Science and Transportation Committee.

{mosads}Brain-Pad advertised that its mouthpiece “creates a new safety space” and “reduces risk of concussions.”

But the FTC said scientific evidence didn’t back up the claim made by the company. The commission, however, said the product can reduce impact on the lower jaw and help protect teeth.

“It’s a big leap to say these devices can also reduce the risk of concussions. The scientific evidence to make that claim just isn’t adequate,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection, in a statement.

Brain-Pad CEO and President Joe Manzo said the company agreed on a settlement, in part, to avoid a legal battle with the FTC and has already altered its advertising claims. But the company does not agree with the FTC claims, he said.

“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,” according to a statement from Brain-Pad.

The commission also issued an administrative complaint against Brain-Pad, in addition to the settlement, that has the potential to carry with it a $16,000 fine. The final ruling will come in late September, according to the FTC.

Udall introduced legislation last March that would require football helmets to meet safety standards and would increase potential penalties on manufacturers that made false health claims about their safety products.

Companion legislation was introduced in the House. The bill hasn’t made it out of committee.

This story was updated on Aug. 17, 2012 at 4:07 p.m.


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