FDA Issues Two Warning Letters for Product That Purport to Treat Concussions

The Food and Drug Administration (FDA) has issued warning letters to PruTect Rx and Trinity Sports Group Inc. for promoting products labeled as dietary supplements but, in reality, are new drugs. The products claim to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders, according to an FDA news release. Claiming to treat these conditions is a mislabeling of the product as these conditions require a medical professional for treatment.

Products

These determinations were made after a review of websites, Facebook pages, and Twitter postings about the products. The products are Neuro Impact Concussion Response Formula appearing on the trintysportsgroupinc.com and neuroimpact.net websites and NeuroPruTect, Omega3PruTect, VitaminD3PruTect, and OsteoPruTect appearing on the prutectrx.com website.

A review of the websites on which these products were promoted show that their intended use was to cure, mitigate, treat or prevent disease and, as such, they are new drugs as defined by sec. 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FFDCA). New drugs under section 201(p) of the FFDCA or  21 U.S.C. §351(f)(1) may not be legally marketed in the United States without prior approval from the FDA.      

In addition, these products are offered for conditions that are not suitable for self-diagnosis and treatment by individuals who are not medical practitioners. For that reason, it is not possible for adequate directions to be written for use of these substances so a layperson could use these substances for their intended purposes. For these reasons, the products are in violation of 21 U.S.C. §352(f)(1) in that their labeling fails to contain adequate direction for use.

Actions to Take

“Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatment,” said Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. These products have not been approved for the treatment of concussions. Individuals are encouraged to contact a physician or health care provider if they believe they have suffered a concussion or if they have experienced problems as a result of taking or using these products, said the FDA news release. Adverse reactions from these products maybe reported to FDA’s MedWatch Adverse Event Reporting Program.

The two companies were given 15 days from the date of the letters to change the language on their websites and provide documentation showing how the promoting of these products is in compliance with the law.