Some Dietary Supplements Claim to be a Concussion Cure, FDA Issues Warnings

As public concern over concussions, especially sports-related concussions in teenage football and soccer players, grows, some supplement manufacturers are exploiting the fear and marketing their supplements as Concussion cures.

On Monday, August 25th, the US Food and Drug Administration announced its awareness of the problem on its website, stating that the public should not purchase supplements to treat concussion symptoms.

Dietary supplements do not face the same strenuous guidelines and regulations as prescription medications, which has created a boom in the herbal and all-natural dietary supplement industry. However, investigations into the ingredients in these supplements has shown that many contain unregulated active pharmaceutical ingredients, or even banned pharmaceuticals. For example, a vitamin B supplement, called Healthy Life Chemistry by Purity B-50, manufactured by Mira Health Products Ltd. of Farmingdale, was found to contain an undeclared anabolic steroid; MyNicKnaxs, LLC, based in Florida, issued a drug recall for Reduce Weight Fruta Planta because it contained a little more than 10 mg of Phenolphthalein, or FenPhen, a banned weight loss drug; Nova Products, Inc issued a voluntary drug recall for several sexual enhancement supplements due to undeclared, FDA-approved drugs that are normally used to treat erectile dysfunction, which can interfere with heart and blood-thinning medications; and, most notoriously, a workout energy supplement, OxyElite Pro, was recalled by the FDA because an undeclared and untested active ingredient caused hepatitis and liver failure in several consumers.

Not only can supplements have undeclared active pharmaceutical ingredients, they can also make bogus claims about their effectiveness that the FDA cannot regulate.

“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,” said Gary Coody, FDA’s National Health Fraud Coordinator. “Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs.”

Growing evidence from concussion and TBI studies shows that the best treatment for a concussion is rest from physical and mental activities. Anything that encourages “faster recovery” could potentially injure the brain further.

“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.

The bogus concussion cure supplements are being marketed aggressively through social media, according to the FDA. Parents of children participating in sports are encouraged not to purchase the supplements, and instead, if their child sustains a blow to the head during practice or a game, to take their child to the doctor and follow the doctor’s advice to treat a potential concussion.

“As we continue to work on this problem, we can’t guarantee you won’t see a claim about [traumatic brain injuries],” Coody said. “But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them. If someone tells you otherwise, walk away.”

The Strom Law Firm Can Help with Dangerous Drug Recall Cases

The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs such as dietary or weight loss supplements with undeclared ingredients, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800