In a recent statement, the agency notes that some supplement manufacturers are “exploiting the public’s rising concern about concussions” by “offering untested, unproven, and possibly dangerous products” regarding concussions and other TBIs.
The FDA is issuing warning letters to supplement manufacturers for them to stop making claims that their products can help prevent or treat TBIs, “because the claims are not backed with scientific evidence that the products are safe or effective for such purposes,” according to the agency’s statement.
One manufacturer actually claimed it could create faster healing after a TBI. If that were even true, the claim could be unsafe.
"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," says Gary Coody, FDA’s National Health Fraud Coodinator. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."
A TBI can be caused by a blow to the head, or by violent shaking of the head and upper body, and it requires treatment by a heath care professional. Resuming activities that caused a TBI in the first place too quickly can lead to a second concussion with can cause morebrain damage or even death, according to the FDA statement.
“There is simply no scientific evidence to support the use of any dietary supplement for the prevention of concussions or the reduction of post-concussion symptoms that would allow athletes to return to play sooner,” says Charlotte Christin, acting director of FDA’s Division of Dietary Supplement Programs.
The FDA acknowledges that some supplements making false claims can fall through the cracks. Unlike prescription drugs, there is no registration process for them to market their products, and there are 85,000 supplements on the market.
Dietary supplements making the false claim for TBI contain ingredients such as turmeric (an Indian spice), and high levels of omega-3 fatty acids from fish oil, neither of which have been tested to treat TBI. The FDA notes that one manufacturer made the claim that it was "the world's first supplement formulated specifically to assist concussion recovery," with “the dynamic ability to minimize long-term effects and decrease recovery time."
That company and another which was cited by the FDA have changed their websites and product labeling.