FDA Issues Warning Against Supplements Claiming To Treat TBI

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It is one thing for someone you know to offer you an untested household remedy for an injury. It is an entirely other issue when companies begin to do the same thing as a way to sell their products.


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Yet, that is exactly what many supplement makers have been doing, according to a warning from the U.S. Food and Drug Administration. These supplement manufacturers are marketing products as concussion cures or treatments without evidence to support their clams.

“We were taken aback that anyone would make a claim that a supplement could treat [traumatic brain injury],” FDA regulator Jason Humbert stated in the release. Bloomberg Businessweek points out this is especially dangerous. The claims that supplements could heal a concussion may lead athletes with head injuries to believe they are ready to return to play before they are actually healthy enough to participate again.

With brain injuries in the headlines and parents across the nation concerned about the health of their young athletes, many are willing to turn to any product which claims to prevent or treat brain injuries. However, the heightened attention has also brought many less reputable companies into the foray.

Manufacturing vitamins and supplements is an estimated $14 billion business in the U.S. alone, but these supplements are not bound by the regulations of the FDA. They do not go through the rigorous testing or approval, so they can be marketed as a treatment for any illness without any supporting evidence.

“We see more and more unfounded claims, whether it’s a protective device, it’s something like this – a supplement, or some treatment … that claims to treat concussions,” Gerald Gioia, chief pediatric neuropsychology and director at the Children’s National Health System told Businessweek. “There is no evidence at this point that any of these kinds of claims are justified.”

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