FDA cracks down on illegal concussion claims

SILVER SPRING, Md. — The Food and Drug Administration is cracking down on companies claiming their products can speed recovery from concussions, according to a consumer update posted Wednesday. 

"The Food and Drug Administration is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms — the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment or prevention of disease," the agency stated. "The agency also is warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat or cure concussions and other traumatic brain injuries because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and are marketed to consumers using social media, including Facebook and Twitter."

One common claim is that a particular dietary supplement promotes faster healing times after a concussion or other TBI. "Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous," stated Gary Coody, FDA's National Health Fraud Coordinator. "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," he said. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."

A growing body of scientific evidence 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. Moreover, repeat concussions can have a cumulative effect on the brain, with consequences that can include brain swelling, permanent brain damage, long-term disability and death.

"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," added Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs. 

One of the first alarms raised about dietary supplements being promoted to treat TBI came from 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. We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue," said Jason Humbert, a senior regulatory manager with FDA's Office of Regulatory Affairs. "That sparked our surveillance."

Typically, products promising relief from TBIs tout the benefits of such ingredients as turmeric and high levels of omega-3 fatty acids derived from fish oil.

In December 2013, FDA issued a warning letter to Star Scientific for marketing its product Anatabloc with claims to treat TBIs.

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