FDA: No matter that firms market concussion treatments as supplements; they're unapproved drugs

SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group, of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.

The products cited in the warning letters include Trinity Sports Group’s Neuro Impact Concussion Response Formula and PruTect Rx’s NeuroPruTect and Omega3PruTect. These products are in capsule and powder forms. They are marketed online in the United States and internationally.

Under the Federal Food, Drug, and Cosmetic Act, a product is a drug and not a supplement if it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. New drugs may not be legally marketed in the United States without prior FDA approval. Although Neuro Impact, NeuroPruTect and Omega3PruTect are marketed as dietary supplements, they are promoted as drugs through claims made on the firms’ websites.

“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,” stated Dara 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.”

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