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FDA Warning for Concussion Supplement Claims

FDA Warning for Concussion Supplement Claims

September 11, 2012 — The U.S. Food and Drug Administration (FDA) has sent a warning letter to several dietary supplement companies who claimed their products could treat concussions, post-concussion syndrome, or other neurological disorders. The warning letters were sent to two companies based in Colorado and Texas. The products cited in the letter include Trinity Sports Group’s Neuro Impact Concussion Response Formula and PruTect Rx’s NeuroPruTect and Omega3PruTect.

“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,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.”

The FDA has not approved Neuro Impact, NeuroPruTect, or Omega3PruTect for the treatment of concussions or other neurological disorders. The FDA also warns that these products have not been shown to be safe or effective for the treatment of these conditions. The FDA also recommends that people who suffer a concussion or side effects from these supplements should contact a physician immediately.

Dietary supplement manufactures are prohibited from claiming their product can diagnose, mitigate, treat, prevent, or cure any disease or injury. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), a product is a drug — not a supplement — if manufacturers claim it has health benefits. Drugs must receive approval from the FDA before they can be legally marketed in the United States. If the FDA determines that a dietary supplement is actually a drug, the agency can take enforcement action against the manufacturers, including forcibly seizing their products or issuing fines.

Do I have a Dietary Supplement Lawsuit?

The Schmidt Firm, PLLC is currently accepting dietary supplement induced injury cases in all 50 states. If you or somebody you know has been injured by Neuro Impact, NeuroPruTect, or Omega3PruTect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dietary Supplement Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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