FDA warns dietary supplement manufacturers for promoting products as drugs

The FDA issued warnings on Sept. 6 to two dietary supplement manufacturers for promoting unapproved products as treatments for neurological disorders such as concussions, according to a press release.

PruTect Rx received the warning for its NeuroPruTect and Omega3PruTect products, and Trinity Sports Group was warned for its Neuro Impact Concussion Response Formula. The products, sold online in the United States and worldwide, are available in capsule and powder forms.

The FDA said the products, marketed as dietary supplements, are promoted on the companies’ respective websites as drugs. None of the supplements has received FDA approval for treating neurological conditions, and no evidence of their safety or efficacy for this indication has been established, according to the release.

“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 the FDA, and they may not make false or unsubstantiated claims about drugs they sell,” Dara A. Corrigan, associate commissioner for regulatory affairs, said in the release. “Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.”

The FDA issued warnings on Sept. 6 to two dietary supplement manufacturers for promoting unapproved products as treatments for neurological disorders such as concussions, according to a press release.

PruTect Rx received the warning for its NeuroPruTect and Omega3PruTect products, and Trinity Sports Group was warned for its Neuro Impact Concussion Response Formula. The products, sold online in the United States and worldwide, are available in capsule and powder forms.

The FDA said the products, marketed as dietary supplements, are promoted on the companies’ respective websites as drugs. None of the supplements has received FDA approval for treating neurological conditions, and no evidence of their safety or efficacy for this indication has been established, according to the release.

“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 the FDA, and they may not make false or unsubstantiated claims about drugs they sell,” Dara A. Corrigan, associate commissioner for regulatory affairs, said in the release. “Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.”