Utah-based TruVision Health and owner David Brown have been formally warned by the U.S. Food and Drug Administration, or FDA, for what the agency calls “serious violations” of FDA regulations covering supplements. The official warning letter, which was dated November 30, 2017, alleges that TruVision made claims that show Brown’s intention to hawk his company’s products not as dietary supplements but as drugs for serious medical conditions like depression, high cholesterol and even Alzheimer’s disease.
truWeight & Energy™ Gen 2
TruVision’s truWeight & Energy Gen 2 product is made with several ingredients Brown touted with non-allowed claims relating to muscle pain, depression, insulin spikes, migraine and high cholesterol. Here is an example of TruVision attaching a blood sugar claim to its benzylamine component:
The company’s Ubiquinol supplement made a more direct promise, claiming that it could lower “bad” cholesterol levels:
Another supplement that drew FDA’s ire was the company’s Pycnogenol product. Claiming that the compound’s antioxidant action might play a role for sufferers of multiple sclerosis, Alzheimer’s disease, heart failure, prostate issues and more simply went to far, says the agency:
As you might expect, FDA says that none of these supplements, nor the others mentioned in the letter, are officially sanctioned as safe or effective for any of those conditions.
And some of TruVision’s products are further troublesome because they’re peddled for serious medical issues the average person cannot accurately self-diagnose or effectively self-treat treat with over-the-counter supplements.
The company was given the standard 15 working days to address the alleged issues.
Categories: FDA Warning Letters