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The agency issued a warning against these products in response to a number of false claims, including promises to promote faster healing times after a concussion or other traumatic brain injury (TBI).
No scientific evidence exists to support this claim or others, according to a recent FDA news release. The agency advised consumers to avoid these products, which are marketed on social media sites such as Twitter and Facebook and sold online and in various retail stores.
"As amazing as the marketing claims 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," Daniel Fabricant, director of the FDA's division of dietary supplement programmes, said in the news release.
Read: TBI – The facts
Supplements dangerous and untested
The FDA pointed out that dietary supplements marketed as cures or treatments for concussions or other traumatic brain injuries are not only untested, but also possibly dangerous.
These supplements typically contain the Indian spice turmeric and high doses
of omega-3 fatty acids.
The FDA recommends taking no more than 3 grams of omega-3s daily due to increased risk of bleeding, high cholesterol and problems controlling blood sugar levels.
Even if the ingredients in the products aren't harmful, the agency is concerned that those who believe the claims might not take the proper precautions to prevent a concussion or heal properly after such an injury.
What is concussion?
A concussion is a type of serious brain injury that can occur after a hit to the head or rigorous shaking of the head or upper body. These head injuries must be properly diagnosed and treated by a doctor, experts say.
Although the long-term effects of concussions have been the subject of recent debate, research suggests that people who sustain a concussion and resume playing sports or participating in strenuous activities too soon are at greater risk for another concussion. Experts note that concussions have a cumulative effect on the brain, which can cause brain swelling, permanent brain damage or even death.
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 US Department of Defence."We first learned from the military about a product 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."
Two companies identified
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".
Read: Concussion guidelines
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 recognised 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 labelling on their products and updated their websites, according to the news release.
Fake online drugs a health risk
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