The Food and Drug Administration has put industry on notice that it won’t tolerate the rising tide of dietary supplement ingredients being marketed for their role in ameliorating the effects of traumatic brain injury.
Traumatic brain injury (TBI) has increasingly become a public health concern, starting with the military’s concern about the role TBI plays in Post Traumatic Stress Syndrome (PTSD). With better medical care in the field and better protective equipment, more and more soldiers survive being close to explosions, when they may have died in the past. Now health care professionals are looking at TBI and the resultant degradation of brain tissue as a physical link in PTSD, which was looked at primarily as a purely psychological condition in the past.
And the rash of cases of cognitive disability among former NFL players who suffered multiple concussions in their careers and the resulting large-scale (and recently settled) lawsuit against the league filed by former players raised awareness of the condition, too.
On Dec. 31 FDA issued a consumer alert on the subject . The agency noted that a common claim made by marketers of these supplements is that they promote faster healing times after a concussion or other TBI, a claim the agency calls potentially dangerous.
"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. Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs," said Gary Coody, FDA's National Health Fraud Coordinator.
Among the ingredients promoted for neuroprotectie properties in conjunction with TBIs are omega-3s and turmeric, the agency said. FDA issued two warning letters in 2012 to companies marketing supplements based on those ingredients that claims to protect against post concussion syndrome And it recently cited Star Scientific for making similar claims for its Anatabloc dietary supplement, based on a molecule called anatabine (FDA took the company to task on a number of other issues, too ).
“There is no dietary supplement that has been shown to prevent or treat (TBIs). If someone tells you otherwise, walk away,” Coody said.
Niagen for neuroprotection
Chromadex, and analytical testing, consulting and ingredient development firm, has an ingredient, Niagen, that has been studied for its neuroprotective properties. A company called High Performance Nutrition launched a supplement based on the ingredient aimed at a market of participants in contact sports.
HPN’s product, called N(R), was be launched at the National Athletic Trainer's Association 64th Annual Meeting & Clinical Symposia last summer.
"N(R) addresses the recent discovery that protection from brain injury should start off the field before it continues on the field with barriers such as helmets," said Sean Torbati, CEO and president of HPN at the time of the launch.
Chromadex has been accumulating the IP surrounding nicotinamide riboside (NR) for a couple of years, having licensed patents from Cornell University, Dartmouth College, and Washington University in St Louis. The Washington patent related to the use of NR for the prevention or treatment of neuropathies caused by axon degeneration.
Frank Jaksch, founder and CEO of ChromaDex, told NutraIngredients-USA at the time of the HPN launch that there is data showing that taking NR in advance of neuronal or axon trauma may prevent damage to the axon. The ingredient has clear potential in sports nutrition where the prevalence of repeated blows to the head in contact sports such as football, soccer and hockey has raised the concern of scientists, public officials, athletes and parents.
Agrees with warning
As far as FDA’s consumer warning is concerned, Jaksch had this to say: I agree with what they are saying. You can’t promote a supplement to treat disease. We have to be pretty crafty about how we structure that language of what we say.”
“Those companies that have been warned about that should have been more mindful about that. It’s not a big surprise that FDA came out with this warning, because those companies were making claims that were way beyond aggressive in terms of the benefit that they were promoting.
“We are way more guarded in what we say, although we are aggressively pursuing this category, because we believe that there are some potential benefits of Niagen in this area,” Jaksch said.