The U.S. Food and Drug Administration (FDA) has issued an alert warning consumers to avoid dietary supplements marketed with claims to prevent, treat or cure concussions and other traumatic brain injuries (TBIs) because the claims are not backed with “scientific evidence that the products are safe or effective.”The alert identified one manufacturer, the Virginia-based Star Scientific, Inc., which FDA accused in a December 20, 2013 warning letter
(summarized elsewhere in this Report) of illegally marketing its anti-inflamma- tory product, Anatabloc, as effective in treating TBIs.
Calling such products “untested, unproven and possibly dangerous,” the agency cites a growing body of research which indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. “As amazing as the marketing claims here are, the science doesn’t support the use of any dietary supplements for the prevention of concussions or the reduction of post-concussion symptoms that would enable one to return to playing a sport faster,” said Daniel Fabricant, director of FDA’s Division of Dietary Supple- ment Programs.
The agency has also criticized manufacturers of exploiting increasing public interest in concussion injuries as research about head trauma in athletics allegedly linking repeated concussions to brain problems later in life continues to mount. FDA stated that it would monitor the marketplace for products with similar fraudulent claims and will take appropriate regulatory action to protect the public health. “We can’t guarantee you won’t see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them,” said FDA National Health Fraud Coordinator Gary Coody. “If someone tells you otherwise, walk away.”