FDA Warns Against Concussion-Curing Claims on SupplementsBy
If you’ve sustained a concussion—a brain injury from head trauma that can manifest in such symptoms as headaches, confusion, and amnesia—doctors recommend lots of rest. Taking dietary supplements to accelerate recovery or prevent traumatic brain injury won’t help, they say.
That hasn’t stopped some supplement makers from marketing products as concussion cures, a practice the U.S. Food and Drug Administration warned consumers about this week. “We were taken aback that anyone would make a claim that a supplement could treat [traumatic brain injury],” FDA regulator Jason Humbert said in the agency’s alert. Claims that supplements can help heal concussions could be dangerous if they led athletes with head injuries to return to play before they’re ready, the FDA says.
In 2012 the agency warned two companies that made such claims. The FDA sent a warning letter to a third, Star Scientific, on Dec. 20. The FDA learned about the claims from the military, the agency said.
News of concussions’ lasting effects on football players has increased public awareness of traumatic brain injuries. Heightened concerns may have led to new purported treatments, says Gerald Gioia, chief of pediatric neuropsychology and director of the concussion recovery program at the Children’s National Health System. “We see more and more unfounded claims, whether it’s a protective device, it’s something like this—a supplement, or some treatment … that claims to treat concussions,” he says. “There is no evidence at this point that any of these kinds of claims are justified.”
Manufacturing vitamins and supplements is an estimated $14 billion business in the U.S., according to market researcher IBISWorld, and it’s one that increasingly interests pharmaceutical companies. Supplements don’t require pre-market approval from the FDA. As such, they need not go through the rigorous, years-long clinical testing that FDA-approved drugs must undergo.
Because vitamins and supplements aren’t vetted before they hit the market, companies selling them cannot legally claim they cure or prevent diseases. When the FDA discovers marketing claims that cross the line, the agency’s first step is to issue a warning.
For example, Star Scientific, is a Nasdaq-listed developer of so-called nutraceutical dietary supplements that makes a product from anatabine, a plant-derived substance. The FDA flagged materials on the company’s website that claimed the substance “has the potential to alleviate the negative consequences of traumatic brain injury” and appears “to completely prevent the loss of spatial memory retention following TBI,” among other things. A 300-pill bottle costs $99.99. (It’s also sold as a facial cleanser starting at $25 per tube, according to the company’s website.)
Star Scientific has removed some portions of its website, spokeswoman Talhia Tuck says. A company statement issued on Dec. 31 says Star Scientific has told the FDA “that it intends to work cooperatively to resolve these issues.” The company’s shares dropped 14 percent, to $1.02, in two trading days since the FDA letter was made public.
There’s a growing drumbeat from the medical community warning consumers that vitamins and supplements are generally useless and potentially harmful. (This feature by Paul Offit in The Atlantic last July offers a good history of the science and pseudoscience behind supplement claims.) Doctors pulled no punches in a December editorial in the Annals of Internal Medicine:
Most supplements do not prevent chronic disease or death, their use is not justified, and they should be avoided. This message is especially true for the general population with no clear evidence of micronutrient deficiencies, who represent most supplement users in the United States and in other countries.
Loose regulations mean marketing will often outpace watchdogs’ ability to police supplement makers’ claims. As the FDA itself notes, “with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.”