FDA Warning for Concussion Supplement Claims

September 11, 2012 — The manufacturers of three supplements marketed for the treatment of concussions have received warning letters from the U.S. Food and Drug Administration (FDA) for promoting unapproved products as drugs. The products include Trinity Sports Group’s Neuro Impact Concussion Response Formula, and PruTect Rx’s NeuroPruTect and Omega3PruTect. The two companies, Trinity Sports Group and PruTect Rx, are based in Colorado and Texas.

According to Dara A. Corrigan, FDA associate commissioner for regulatory affairs, “The FDA has taken these actions because companies may not sell new drugs unless the drugs have been tested by the sponsor and approved by FDA, and they may not make false or unsubstantiated claims about drugs they sell.” Furthermore, “Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.”

A concussion is a minor traumatic brain injury that can affect brain function. It can cause headache, loss of consciousness, or changes in alertness. Severe concussions can cause convulsions, seizures, persistent confusion, coma, muscle weakness, and other long-term side effects. Any time a concussion is suspected, medical care should be sought immediately.

The dietary supplements Neuro Impact, NeuroPruTect, and Omega3PruTect are not FDA approved to treat concussions or any other neurological disorder. These products are not shown to be safe or effective to treat these conditions.

Manufacturers of dietary supplements are not allowed to claim their supplement can diagnose, treat, cure, prevent, or mitigate any disease. It is illegal under the Federal Food, Drug, and Cosmetic Act (FFDCA), which allows only drugs (not dietary supplements) to claim their product has health benefits. Supplements are regulated much differently than drugs. Drug companies must gain FDA approval before they can sell their product, and they are usually required to conduct safety studies. If a dietary supplement is marketed as a drug, the FDA can take enforcement action against the manufacturers.

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