7 Sep 2012 --- The U.S. Food and Drug Administration today issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., 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 (FFDCA), a product is a drug 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,” 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.”
Neuro Impact, NeuroPruTect, and Omega3PruTect have not been approved by the FDA for treatment of concussions or for prevention or treatment of post-concussion syndrome or other neurological disorders, nor have the products been shown to be safe and effective for these purposes. Consumers should contact a physician or health care provider if they believe they have suffered a concussion, or if they have experienced any problems that may be related to taking or using these products.
MedWatch is the FDA’s program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.