FDA Warning

2015-0104 FDA

According to CBS News. “The U.S. Food and Drug Administration (FDA) is warning consumers about dietary supplements that falsely claim to prevent or cure concussions or other traumatic brain injuries. The FDA says supplements with labels that make these claims are not backed up by scientific evidence, and in a consumer alert it urged users to beware.”

“Additionally, the FDA says some companies have marketed these products to military service members and veterans who have sustained combat-related traumatic brain injuries. The U.S. Department of Defense was among the first to raise concerns.”

“The FDA has taken action in the past to crack down on companies touting medical benefits that have not been proven. In 2012, the FDA issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., of Plano, Texas, for marketing supplements for post-concussion syndrome. Both companies made the required changes.”

“Dr. Michael Lipton, associate director of Albert Einstein College of Medicine’s Gruss Magnetic Resonance Research Center and medical director of MRI services at Montefiore Medical Center in New York, said ‘such products send the wrong message, and could be dangerous because athletes may come to believe their false claims.'”

“Some products marketed for traumatic brain injury and concussion contain turmeric and large doses of omega-3 fatty acids from fish oil. A study published in the Journal of Neurosurgery in 2012 found fish oil supplements increased levels of omega-3s in the brain, which are said to protect the brain by increasing the ability of neurons to tolerate injury. Though the research is scant, some studies do link omega-3s to reduced brain inflammation. However, Lipton says none of these studies have been replicated in humans.”

Note: an FDA warning implies the products in the warning have not been proven to work as indicated. The warning is not an implication the products do not work as indicated.

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