The U.S. Food and Drug Administration 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 issued Monday 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 warning comes as school is starting up again many student athletes are getting back into competitive sports that can lead to concussion and other serious injuries. The risk for head trauma from contact sports, such as football and wrestling, has provided another marketing opportunity for companies to make false claims that certain dietary supplements can help cure or prevent these types of injuries.
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. Joe Ford, who helped develop NeuroImpact, produced by Trinity Sports Group, said he received a letter from the FDA two years ago telling his company to change its marketing language. "Initially it was promoted as a concussion recovery dietary supplement," he told CBS News. "We certainly never intended for it to come across as a cure." His company now markets the product as a "body and brain support for active lifestyles."
Ford said his product, which contains 18 different ingredients, is the first to be patented as a supplement for full and healthy brain function. There isn't any information about the compound ingredients on the company website. The company says the product is used and endorsed by a number of athletes, including Ben Watson of the New Orleans Saints and Sammy Morris of the Dallas Cowboys, as well as several professional mixed martial arts fighters.
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.
"I think the bigger problem here is that we don't want people to have the impression that there's a pill they can take that substitutes [for] being careful," Lipton told CBS News.
Some products marketed for traumatic brain injury and concussion contain turmeric and large doses of omega-3 fatty acids from fish oil. A mouse 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.
Athletes who suffer repeated concussions, or insist on getting back in the game too soon, are at risk for long-term cognitive health problems including CTE, or chronic traumatic encephalopathy. There currently isn't a way to expedite the recovery from concussion. Doctors typically recommend a patient gets plenty of rest and allows the body to heal naturally at its own pace, which varies from person to person but can take weeks. Lipton also recommends his patients stay well hydrated and eat healthfully.
"The only way to prevent a concussion is to not have a head injury," said Lipton "The mainstay of treatment for concussion is letting the brain heal by giving it enough time without physical and cognitive stress."