FDA Warning Letters

TruVision Health Formally Warned – “Misbranded”, “Adulterated” Supplements

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:

truWeight & Energy™ Gen 2 is sold with non-allowed claims about insulin.

An archived page showing one of the insulin-related claims specifically mentioned by FDA in its warning letter to TruVision.

Ubiquinol

The company’s Ubiquinol supplement made a more direct promise, claiming that it could lower “bad” cholesterol levels:

Thus ubiquinol actually keeps your LDL (often referred to as the “bad” cholesterol) reduced.

TruVision’s cholesterol claim made for its Ubiquinol supplement was another health promise that got the company in trouble.

Pycnogenol

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:

FDA fires warning letter about TruVision's Pycnogenol product.

Saying that its Pycnogenol supplement could aid sufferers of conditions like Alzheimer’s, cancer, M.S., dementia, coronary failure, stroke, and pulmonary disease only deepened TruVision’s troubles.

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.

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