FDA Warns Against Concussion-Curing Claims on Supplements

If youve sustained a concussiona brain injury from head trauma that can manifest in such symptoms as headaches, confusion, and amnesiadoctors recommendlots of rest. Taking dietary supplements to accelerate recovery or prevent traumatic brain injury wont help, they say.

That hasnt stopped some supplement makers from marketing products as concussion cures, a practice the U.S. Food and Drug Administrationwarned 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 agencys alert.Claims that supplements can help heal concussions could be dangerous if they led athletes with head injuries to return to play before theyre ready, the FDA says.

In 2012 the agency warnedtwo companies that made such claims. The FDA sent a warning letter to a third, Star Scientific (STSI), on Dec. 20. The FDA learned about the claims from the military, the agency said.

News of concussions lasting effects on football playershas increased public awareness of traumatic brain injuries. Heightened concerns may have led to new purported treatments,saysGerald Gioia, chief of pediatric neuropsychology and director of the concussion recovery program at the Childrens National Health System. We see more and more unfounded claims, whether its a protective device, its something like thisa 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 businessin the U.S., according to market researcher IBISWorld, and its one that increasingly interests pharmaceutical companies.Supplements dont 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 arent 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 agencys 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 companys website thatclaimed 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. (Its also sold as a facial cleanser starting at $25 per tube, according to the companys 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 companys shares dropped 14 percent, to $1.02, in two trading days since the FDA letter was made public.

Theres 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 theAnnals 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.

Continue reading here:
FDA Warns Against Concussion-Curing Claims on Supplements