Dietary Supplements Can't Treat or Cure Concussions
Agency tells consumers to ignore manufacturer claims and 'walk away' from these products
"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," Gary Coody, the FDA's national health fraud coordinator, said in the news release. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBI."
Jason Humbert, a senior regulatory manager with the FDA's Office of Regulatory Affairs, said the agency was first notified about dietary supplements being sold as cures or treatments for concussions by the U.S. Department of Defense.
"We first learned from the military about a product being marketed to treat TBI -- obviously a concern with wounded veterans," Humbert said. "We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue. That sparked our surveillance."
The FDA has so far identified two companies that sell more than one product promising to prevent and treat concussions or other types of traumatic brain injuries.
One company claimed its product has "the dynamic ability to minimize long-term effects and decrease recovery time," according to the FDA. A National Football League player also vouched for the product's "proven results" in his own recovery from a concussion. Meanwhile, an unidentified "licensed trainer" reportedly uses the product in his "concussion-management protocol."
The second company made similar claims for four products it is selling.
The FDA sent letters of warning to both companies in 2012, which stated that the supplements did not have adequate directions for their use and were generally not recognized as safe and effective for treating concussions or other brain injuries. The FDA notified the companies that legal action, such as seizure or injunction, could result if violations were not corrected. Since then, both companies have changed the labeling on their products and updated their websites, according to the news release.
In 2013, the FDA also sent a warning letter to Star Scientific, Inc., in response to claims that its product Anatablo treats traumatic brain injuries. The agency said it continues to screen the marketplace for other supplements with similar bogus claims and will take the necessary action to protect the public.
"As we continue to work on this problem, we can't guarantee you won't see a claim about TBIs," Coody said. "But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them. If someone tells you otherwise, walk away."