FDA Sends Warnings to PruTect Rx, Trinity Sports Group
The FDA has issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., of Plano, Texas, for promoting dietary supplements with claims that they 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, in capsule and powder forms.
None of the products have been approved by the FDA for treatment of concussions or for prevention or treatment of post-concussion syndrome or other neurological disorders. In addition, the FDA says that the products have not been shown to be safe and effective for these purposes.