FDA Warns Against 'Concussion' Supplement Claims
The FDA is warning consumers to avoid dietary supplements marketed with claims to prevent, treat, or cure concussions and other traumatic brain injuries (TBIs) because there is no scientific evidence to support these purposes.
A common claim states that using a particular dietary supplement promotes faster healing times after a concussion or other TBIs. Products being promoted for TBI relief include turmeric and high levels of omega-3 fatty acids.
For omega-3, a maximum daily level of 3g per day is recommended by the FDA since higher levels have been associated with bleeding risk, possible increases in cholesterol, and problems with regulating blood sugar.
One of the earliest claims raised about dietary supplements treating TBIs came from the U.S. Department of Defense. The FDA also identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs.
In 2012, the FDA responded with warnings to both companies that their products were not generally recognized as safe and effective for treating TBIs, and that the products were misbranded.
Recently, the FDA issued a warning letter to Star Scientific for marketing Anatabloc with claims to treat TBIs.
The FDA is continuing to monitor the marketplace for products with similar false claims.
For more information call (888) 463-6332 or visit the FDA Safety Alert page.