The U.S. Food & Drug Administration (FDA) just issued warning letters to the makers of dietary supplements that purport to treat concussions.
The warnings letters were issued to the PruTect Rx, of Highlands Ranch, Colorado and Trinity Sports Group Inc., of Plano, Texas, for promoting products labeled as dietary supplements and which claim to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.
The products cited are Trinity Sports Group’s Neuro Impact Concussion Response Formula and PruTect Rx’s NeuroPruTect and Omega3PruTect, which are made in capsule and powder forms. The supplements are marketed online in the United States as well as internationally.
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), a product is deemed 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 U.S. without prior FDA approval. Neuro Impact, NeuroPruTect, and Omega3PruTect are marketed as dietary supplements, but are promoted as drugs through claims made on the firms’ web sites.
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; the drugs have also not been shown to be safe and effective for these purposes.
“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,” Corrigan added.
The FDA advises consumers to contact a physician or health care provider if they believe they have suffered a concussion, or if they have experienced problems related to taking or using these products.
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: Online, go to www.fda.gov/medwatch/report.htm or by regular mail or fax, use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm, and either mail to the address on the pre-addressed form or fax to 1.800.FDA.0178.