FDA Warns About Supplement Claims to Treat, Cure Concussions

Supplement-Claims-to-Treat-Cure-ConcussionsThe U.S Food and Drug Administration (FDA) just issued a warning concerning supplement claims to treat or cure concussions.

According to the agency, no proof exists that dietary supplements treat or cure concussions, according to KSBY.com. Also, while supplements may not contain dangerous ingredients, experts point out that the bogus claims may convince athletes, coaches, or parents that the injured person is ready to return to normal activities before it is safe to do so.

The FDA warns that, with school starting, football, soccer, and other sports practices may be beginning and that there is the potential for injuries due to violent jarring and shocks. The FDA also notes that some supplement makers are offering untested and unproven products that may be dangerous and that claim to prevent, treat, or cure traumatic brain injuries (TBIs), such as concussions. The FDA described these marketing practices as exploiting the public’s mounting concern about these injuries.

The agency announced that it is monitoring the marketplace and taking enforcement actions when needed, such as issuing warning letters to firms, which is the typical first step when claims are received involving products labeled as dietary supplements and also labeled for use in the cure, mitigation, treatment, or prevention of disease. The FDA warns consumers against using purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs as these claims are not backed by scientific evidence concerning the safety or efficacy of these products for these purposes.

The U.S. Department of Defense was the first to raise concerns. “We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, which is a hot-button issue,” said Jason Humbert, senior regulatory manager with FDA’s Office of Regulatory Affairs. “That triggered our surveillance.”

At its first review, the FDA identified two companies selling a number of products claiming to prevent and treat concussions and other TBIs. In 2012, the agency sent warning letters to both companies. Both companies changed their websites and labeling. In December 2013, the agency issued a warning letter to another company and indicated that it would take appropriate regulatory action to protect the public health.

One of the claims involved that use of a particular dietary supplement promoted quicker healing following a TBI. This type of claim may pose dangers, even if the supplement does not contain harmful ingredients, said Gary Coody, FDA’s National Health Fraud Coordinator. “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,” Coody added. “Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs.”

Concussion are brain injuries caused by a blow to the head, or by a violent shaking of the head and upper body. These, and other TBIs are serious medical conditions, which should be appropriately diagnosed, treated, and monitored by a health care professional. Increasing evidence reveals that should concussion victims resume strenuous activities—football, soccer, or hockey, etc.—too quickly, they are at increased risks for suffering another concussion. Repeat concussion are known to have cumulative brain effects that may be catastrophic, such as brain swelling, permanent brain damage, long-term disability, and death.

“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,” said Charlotte Christin, acting director of FDA’s Division of Dietary Supplement Programs. “As we continue to work on this problem, we can’t guarantee you won’t see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them,” said Coody. “If someone tells you otherwise, walk away.”

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2020 Parker Waichman LLP ®. All Rights Reserved.